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Background | The World Health Organization recommends birth companionship for all women in labor. There is insufficient evidence on birth companionship in low-income settings and it is not clear if role orientation impacts effectiveness. The aim of this study was to assess the efficacy of midwife-led role orientation of birth companions of on maternal satisfaction and birth outcomes in a sub-region in Uganda. | PMC10506214 | ||
Methods | A stepped wedge cluster randomized trial conducted (control | PMC10506214 | ||
Results | Mean maternal satisfaction rate was significantly higher in the intervention period compared to the control period ( | PMC10506214 | ||
Conclusion | birth companions | Midwife-led role orientation of birth companions increased maternal satisfaction. Nevertheless, no significant effect was noted in the mode of delivery, length of labor, Apgar score, and need to augment labor. Findings could inform the integration of birth companions in the admission process of the woman in labor in similar settings. | PMC10506214 | |
Trial registration number | NCT04771325. | PMC10506214 | ||
Keywords | PMC10506214 | |||
Background | There has been progress in the maternal and neonatal mortality rates in Uganda. This has been mainly attributed to skilled birth attendance [The World Health Organization (WHO) recommends that every woman be supported continuously throughout labor by a companion of choice to promote a positive childbirth experience [Several barriers have been identified in the implementation of the presence of a companion of choice at birth in resource strained hospital settings. Amongst these is the absence of clear communication with the companion about their role [There is a deficit of evidence on the effect of continuous labor support in low-income settings. Also, it is still unknown if training improves the effectiveness of continuous labor support [ | PMC10506214 | ||
Methods | PMC10506214 | |||
Study setting | The study was carried out in the Bugisu sub-region located in the Eastern part of Uganda. The Bugisu sub-region consists of six districts, including Manafwa, Mbale, Bududa, Sironko, Namisindwa, and Bulambuli. According to the Uganda National Bureau of Statistics, the sub-region is home mainly to the Gisu people with an average household size of 4.8 and a literacy rate of 51.5% [ | PMC10506214 | ||
Control (usual care) | Women are escorted to the health facilities by one or more family members or friends. One person is allowed besides her to provide support. The support persons do not receive any orientation sessions and have no designated roles. Information is provided on the need arise basis. That is; when the midwife needs anything in particular or help from the birth companion. Routine analgesia is not given. Midwives, medical officers, and obstetricians provide skilled care. Typically, two to three midwives are allocated per 8-h shift managing about six laboring women at a given time. | PMC10506214 | ||
Outcomes | birth companions, anxiety | DILATION, SECONDARY | The primary outcome was the chance of having a spontaneous vaginal delivery. The secondary outcomes were; the incidence of having a spontaneous vaginal delivery, length of labor, Apgar score, coping, anxiety and maternal satisfaction. Maternal anxiety and coping during labor are reported in another article and can be accessed at Sample size and randomization: The sample size for this trial was calculated based on the primary outcome (incidence of having a spontaneous vaginal delivery). The baseline rate for having a spontaneous delivery was 87%. We assumed that guiding birth companions on continuous labor support contributed to a 10% difference (minimally relevant difference between the two groups as 0.1). We set Alpha at 95% CI (0.05 = 1.96), β multiplier for 80% at 0.842. A sample size of 290 participants per period was calculated. The number of study participants was selected proportionately; that is, according to the patient volumes of the particular facilities. Approximately 12,500 women delivered during the study period including the 6 months break of the COVID-19 lockdown (see Fig. Maternal satisfaction across study periodsRandomization for stepped wedge trials is not performed individually but rather involves the crossover of clusters from control to intervention until all clusters are exposed [Data were collected from the woman’s labor clinical notes using a data abstraction form. The first part entailed the woman’s socio-demographic information and obstetrical information including; parity, weeks of gestation, status of membranes on admission and birth weight. The second part contained the time of admission and cervical dilation on admission, time of delivery, duration of 1 | PMC10506214 |
Data management and analysis | Data was entered using excel and imported to STATA 14 for analysis [ | PMC10506214 | ||
Results | PMC10506214 | |||
Discussion | birth companions, anxiety | In this study, we assessed the efficacy of midwife-led role orientation of birth companions of on maternal satisfaction and labor outcomes. Results from our study showed that the mean maternal satisfaction rate was significantly higher in the intervention period compared to the control period. And, there were no statistically significant differences between mode of delivery, length of labor, Apgar score, and need to augment labor.The World Health Organization framework for improving quality of care for pregnant women during childbirth highlights experience of care as important as clinical care provision in achieving desired person-centred outcomes [High maternal satisfaction levels from sub-group analysis were noted among the women who were; at the regional referral hospital, younger, first-time mothers, and unmarried. Better results reported at the referral hospital could be attributed to the seniority of the midwives. Additionally, this was in a fairly urban setting and the effectiveness of the intervention was probably associated with income, and educational level of birth companions [Support during childbirth is an important aspect of maternal satisfaction with care. Findings from a study conducted in Uganda showed that women desired the presence of someone most especially when health workers were not available. They needed reassurance, encouragement, and motivation for them to ably navigate through the birthing process [Non-significant findings on birth outcomes are similar to findings from a study where the rates of cesarean section delivery were almost identical in the intervention and control groups. Moreover no significant differences were noted in maternal and neonatal outcomes [A possible explanation for the contrast of findings in our study could be attributed to short duration of the intervention. The birth companions in our study had one session of orientation for 20 min on admission; this was probably not enough to make a difference. The current study found that orientation had a greater effect on the psychological outcomes (anxiety, coping and maternal satisfaction) [Whereas the midwife providing an orientation for birth companions had no significant effect on the biological process of labor, it had an immediate positive effect on how women experienced care given. We also recognize that midwives providing a detailed orientation for birth companions may perhaps be a challenge with large numbers of women in labor at a given time. Also, the short time of interaction may limit building good relations with the midwife lessening the effect of the intervention. Midwives could consider group sessions, illustration chats and videos in the admission areas of busy maternity units. Evaluation of the acceptability and perceptions of birth companions and midwives regarding orienting birth companions is essential for implementation. Furthermore, we excluded women with special needs like mental illness, deaf or mute. Future studies could explore birth companionship for such women because they might need even more support during childbirth. | PMC10506214 | |
Strengths and limitations of the study | The selected study design had the following strengths; Firstly, the facilities were their own controls hence buffering the effects of heterogeneity. Secondly, the stepped wedge design limited contamination of the intervention arm considering the socio nature of the intervention. Also, subgroup analysis of treatment effects of clusters and participants provided useful information for specific baseline characteristics of women. These findings could be used to tailor specific interventions for women.On the other hand, caution should be taken in generalizing the findings. The clusters were few and had a low power to determine true statistical differences. Secondly, observations collected soon after the roll-out of the intervention and observations collected after sometime could have been different which might have affected the overall treatment effect. Furthermore, only one session of orientation was done and this could have lessened the effect of the intervention. Also birth attendant details like sociodemographic characteristics and years of experience were not captured and could have affected the delivery of the intervention. | PMC10506214 | ||
Acknowledgements | The authors recognize the Swedish International development Agency for funding the study and the participants of this study who voluntarily agreed to take part in this research. | PMC10506214 | ||
Authors’ contributions | GN | SIDA | EWW conceived and designed the study. EWW, GN and NMT implemented the study and conducted data analysis. GN, JKB, and NMT supervised the study. EWW, GN, JKB, and NMT interpreted study results: EWW wrote the first draft of the manuscript. EWW, GN, JKB and NMT reviewed and corrected the draft manuscript. All authors read and approved the final manuscript. This study is part of EWW’s doctoral research funded by (SIDA) through a Makerere-Sweden Research collaboration. | PMC10506214 |
Funding | SIDA | This study is part of EWW’s doctoral research funded by the Swedish International development Agency (SIDA) through a Makerere-Sweden Research collaboration. | PMC10506214 | |
Availability of data and materials | The data that support the findings of this study are available from the first and corresponding author, Eva Wodeya Wanyenze. | PMC10506214 | ||
Declarations | PMC10506214 | |||
Ethics approval and consent to participate | This study was approved by the Makerere School of Health Sciences Research Ethics Committee (SHSREC REF: 2017–54) and the Uganda National Council for Science and Technology (HS377ES). Administrative clearance was also obtained from the health facility (UG-REC-011). Written informed consent was sought from participants prior to enrollment in the study. In Uganda, emancipated minors are individuals below the age of 18 who are pregnant, married, have a child or cater for their own livelihood [ | PMC10506214 | ||
Consent for publication | Not applicable. | PMC10506214 | ||
Competing interests | The authors declare no competing interests. | PMC10506214 | ||
References | PMC10506214 | |||
Purpose | OBSTRUCTIVE SLEEP APNEA SYNDROME | The aim of the present study was to assess the efficacy of the Ronch®AP palatal device in treating patients with moderate and severe forms of obstructive sleep apnea syndrome. | PMC10066138 | |
Methods | Daytime sleepiness, apnea | In a randomized controlled trial 22 patients were examined with the Ronch®AP palatal device after 4 weeks of usage. Their results were compared to a control group of 30 patients who did not receive any treatment during this time. All patients included did not tolerate CPAP therapy. Among other parameters the apnea–hypopnea index (AHI) was measured using nocturnal cardiorespiratory polysomnography. Daytime sleepiness was assessed using Epworth Sleepiness Scale. Pittsburgh Sleep Quality Index was used to analyze sleep quality. | PMC10066138 | |
Results | Using the Ronch®AP palatal device AHI was reduced from an average of 35.34 ± 14.9/h to 19.18 ± 14.93/h, whereas the control group only showed a minimal mean reduction from 31.32 ± 12.76/h to 29.37 ± 17.11/h. The difference in reduction between the two randomized groups was highly significant ( | PMC10066138 | ||
Conclusions | OBSTRUCTIVE SLEEP APNEA SYNDROME | The Ronch®AP device is an effective alternative treatment option for patients suffering from moderate and severe forms of obstructive sleep apnea syndrome and not tolerating CPAP therapy. | PMC10066138 | |
Trial registration number | DER | 407-16 with approval from the local ethical committee (Ethikkommission der Medizinischen Fakultät der LMU München). | PMC10066138 | |
Keywords | Open Access funding enabled and organized by Projekt DEAL. | PMC10066138 | ||
Introduction | chronic disorder, hypopneas, fatigue, choking, airway obstruction, hypopnea, OSA, apnea, daytime sleepiness, Apnea, snoring, arousals, impaired cognition or cardiovascular events, OSAS, collaps, hypopnea inspiratory airflow | CHRONIC DISORDER, CHOKING, OBSTRUCTIVE SLEEP APNEA SYNDROME, AIRWAY OBSTRUCTION, COLLAPSE, EVENTS, EXCESSIVE SLEEPINESS | Obstructive sleep apnea syndrome (OSAS) is a common chronic disorder caused by repetitive pharyngeal collapse during sleep leading to complete or partial airway obstruction during inspiratory airflow. It is characterized by frequent reoccurrences of hypopneas and apneas resulting in strongly compromised blood oxygenation levels resulting in frequent arousals and disrupted sleep often causing excessive daytime sleepiness [OSAS diagnosis is based on the combined evaluation of clinical symptoms and objective sleep study findings. Cardinal symptoms include loud snoring or choking, frequent awakenings and excessive sleepiness. The gold standard to confirm the clinical suspicion of OSAS is cardiorespiratory polysomnography with its primary diagnostic parameter being the apnea–hypopnea index (AHI). Apnea is defined as the complete absence of inspiratory airflow, whereas during hypopnea inspiratory airflow is only reduced. OSAS is defined as five or more episodes of apnea or hypopnea per hour of sleep in association with clinical symptoms (e.g., excessive daytime sleepiness, fatigue, impaired cognition or cardiovascular events) or 15 or more obstructive apnea–hypopnea events per hour of sleep regardless of any associated symptoms. Polysomnography is not only limited to OSAS diagnosis. It also proves to be a useful instrument in assessing severity and guiding therapeutic intervention [The therapeutic spectrum includes behavioral, conservative and surgical treatment options. Continuous positive airway pressure (CPAP) represents the treatment of choice in most patients suffering from OSAS [In the latter, for example, there is the possibility of Barbed reposition pharyngoplasty or Expansion Sphincter Pharyngoplasty. In case of palatal collaps the outcomes in both procedures appear to be comparable in the improvement of OSA and are considered safe procedures [Conservative treatment approaches include oral appliances, such as mandibular protrusion splints and palatal stenting devices. While the effectiveness of mandibular protrusion splints has been thoroughly examined in recent years, scientific evidence for palatal stenting devices is rather scarce [This study presents the first controlled and randomized clinical trial to examine the effectiveness of the Ronch®AP palatal device in treating OSAS patients with CPAP intolerance. | PMC10066138 |
Materials and methods | PMC10066138 | |||
Patients and features | OSAS, daytime sleepiness | CAVITY | From October 2016 to August 2019, 60 patients were evaluated at the Department of Otorhinolaryngology of the Ludwig-Maximilians-University Clinic in Munich. The study examining the effectiveness of the Ronch®AP palatal device in treating OSAS was designed as a randomized and controlled trial. The functional principle of the Ronch®AP is based on the external stenting of the retropalatal space and follows a conservative treatment approach. It is based on the nocturnal usage of an individually adjusted plasticized wire construction with memory effect (Fig. Ronch®AP palatal device: relative size to a paper clip. Source: RonchoLine®Positioning of Ronch®AP palatal device. Source: RonchoLine®Only patients suffering from moderate to severe OSAS with an AHI ≥ 15, and who did not tolerate CPAP therapy, were included. Moderate OSAS was defined as AHI ≥ 15/h, severe OSAS as AHI ≥ 30/h. All patients went through a diligent ENT examination including rhinoscopy, pharyngoscopy and inspection of the oral cavity. If OSAS had previously not been formally diagnosed, but was assumed based on the results of clinical screening and analysis of risk factors, standardized cardiorespiratory polysomnography was conducted for verification. Polysomnographic testing was conducted at the sleep laboratory of the Department of Otorhinolaryngology of the Ludwig-Maximilians-University Clinic in Munich in accordance with AASM guidelines [In addition to polysomnographic parameters daytime sleepiness was assessed using Epworth Sleepiness Scale (ESS) [ | PMC10066138 |
Randomization | Afterward, patients were randomized into one group set to receive therapeutic intervention by Ronch®AP and a control group. For randomization an envelope containing equal amounts of batches for both groups was used. Each group consisted of 30 patients. | PMC10066138 | ||
Statistical analysis | Program R (Version 4.0.1, R Core Team, 2020) was applied for statistical evaluation. For descriptive analysis of parameters absolute values as well as margins were used. Mean value, standard deviation, minimum and maximum were calculated. Two sample | PMC10066138 | ||
Results | sleepiness, OSAS, daytime sleepiness | After the adjustment period was completed, 22 out of 30 patients tolerated Ronch®AP and were approved for polysomnographic testing. In accordance with the study’s protocol 30 patients of the control group did not receive any treatment. 14 women (23.3%) and 46 men (76.75) were included in the study. 32 patients suffered from moderate (AHI < 30/h) and 28 from severe OSAS (AHI ≥ 30/h). Patients suffering from mild OSAS could not be included. Mean age was 58.7 ± 10.9 years and mean body mass index (BMI) 26.8 ± 3.1 kg/mComparability of baseline parameters after randomizationThe effectiveness of the Ronch®AP palatal device was analyzed through the difference in parameter value between the two different times of measurement Effect of Ronch®AP therapy in comparison with no treatment: Baseline values and follow-up results after 1 month (absolute value)AHICorrespondingly, the analysis of treatment success in relation to AHI showed that the different criteria for successful treatment were more often met within the therapy group. 40.9% (Treatment success in regard to AHIEvaluating possible predictors for treatment success, the results showed that the Ronch®AP appliance proved to be more efficient in treating patients with a BMI < 30 kg/mWhile acknowledging that Ronch®AP therapy successfully reduced AHI, other sleep parameters showed no statistically significant improvement in comparison with the control group (Tables Effect of Ronch®AP therapy in comparison with no treatment: parameter differences Differences Apnea obstructivApnea centralApnea obstructivApnea centralResponse rate of treatment success in regard to different success criteria17/0100%/0%13/0100%/0%24/0)100%/0%6/0100%/0%15/1550%/50%28/293.3%/6.7%8/280%/20%10/283.3%/16.7%14/477.8%/22.2%4/0100%/0%9/1340.9%/59.1%20/290.9%/9.1%16/194.1%/5.9%12/192.3%/7.7%23/195.8%/4.2%5/183.3%/16.7%14/1646.7%/53.3%27/390%/10%6/460%/40%9/375%/25%12/666.7%/33.3%3/175%/25%6/1627.3%/72.7%20/290.9%/9.116/194.1%/5.9%8/561.5%/38.5%18/675%/25%6/0100%/0%17/770.8%/29.2%26/292.9%/7.1%6/460%/40%7/558.3%/41.7%10/855.6%/44.4%3/175%/25%6/1331.6%/68.4%16/672.7%/27.3%Subjective treatment effectiveness was evaluated by ESS and PSQI. ESS score showed a reduction in daytime sleepiness from initial 9.18 ± 4.73 to 7.82 ± 4.14 under Ronch®AP therapy, whereas the control group showed increased levels of sleepiness (ESSESS and PSQI22 patients of the therapy group answered the Ronch®AP questionnaire (Tables Therapy adherence and influential variables of Ronch®AP therapySide effects of Ronch®AP therapyCorrelation between side effects and willingness to continue treatment and | PMC10066138 | |
Discussion | hypopneas, respiratory effort-related arousals, obstructive apneas, hypopnea, apnea, daytime sleepiness, snoring, arousals, OSAS, AHI reduction, Daytime sleepiness | MINOR, RESPIRATORY EFFORT-RELATED AROUSAL, POSITIVE | The presented study examined the Ronch®AP palatal device as an alternative conservative treatment option in OSAS therapy. Even though the therapeutic approach to treat OSAS by stenting the retropalatinal space is not novel, little research has been published [The effectiveness of Ronch®AP was examined in a randomized controlled clinical trial over 4 weeks. The study’s strength lies in its design. A controlled, randomized trial minimizes the risk of selection bias. Moreover, cardiorespiratory polysomnography represents the highest diagnostic standard for OSAS and therapeutic management. All polysomnographic testing was conducted in accordance with international standards. The observation interval of 4 weeks was considered suitable for the studies' objective. It allowed the evaluation of the effectiveness of Ronch®AP while upholding ethical standards. As the control group did not receive any treatment during the 4-week time interval, a longer observation period would not have been ethically acceptable.In comparison with the control collective, AHI was significantly reduced from 35.34 ± 14.9/h to 19.18 ± 14.93/h (Analyzing treatment success in regard to different AHI-related success criteria shows that the therapy group performed better in all three categories. By reducing AHI < 10 31.8% patients (The lack of statistical significance in regard to these predictors might be attributed to the modest size of the examined subgroups.The statistically relevant improvement of AHI under Ronch®AP compared to the control group was not found in other sleeping parameters. However, measured by their baseline values significant improvements were observed within the therapy group in regard to apnea index and hypopnea index, the total amount of snoring sounds and snoring index. Positive trends transpired in regard to the total amount of obstructive apneas and hypopneas and the amount of respiratory effort-related arousals. In addition, a minor shift in the sleep profile toward a higher share in deep sleep at the expense of light sleep must be positively acknowledged. Patients under Ronch®AP therapy were five times less likely to awaken after sleep onset. In contrast to the Ronch®AP treatment that had no effect on minimal and average oxygen desaturation, De Bruijn observed a significant increase in both parameters under Velumount® [The fact that objective improvements (e.g., AHI reduction) are also reflected in patients’ positive subjective assessment of treatment effectiveness is highly beneficial for compliance and therapy adherence. Daytime sleepiness and sleep quality were significantly improved compared to patients without treatment. Considering that daytime sleepiness is one of the main symptoms of OSAS and that patients frequently suffer from poor sleep quality due to frequent awakenings and arousals, these results are encouraging. Different studies on Velumount® therapy support the evidence given in the presented study that palatal oral appliances reduce ESS. This is seen in patients’ positive evaluation of palatal appliances in OSAS therapy [In total, this study’s findings are promising. However, the results should be seen in the light of their limitations. The analysis performed only included patients with moderate and severe OSAS. Even though the results for the presented cohort are significant, the study is not able to give evidence for the effectiveness of Ronch®AP therapy for mild forms of OSAS. Furthermore, in future studies reliability and quality of results could be enhanced by choosing larger patient cohorts and assessing the influence of interesting variables, such as location of obstruction occurrence. Data were reduced by early drop-outs in the adjustment process and by incomplete records. It will be interesting to assess if potential predictors for treatment success are identified in future studies with larger sampling sizes. However, the acknowledgement of drop-outs provides intrinsic information on tolerance capacity of Ronch®AP. As the study presents a first-time scientific evaluation of Ronch®AP, the chosen observation period of 4 weeks surely allowed obtaining important information on principal treatment effectiveness. On the other hand the study was not designed to obtain information on long-term compliance and treatment success. | PMC10066138 |
Funding | Open Access funding enabled and organized by Projekt DEAL. | PMC10066138 | ||
Data, materials and/or code availability | Data are available by the authors. | PMC10066138 | ||
Declarations | PMC10066138 | |||
Conflict of interest | The authors have no relevant financial or non-financial interests to disclose. | PMC10066138 | ||
Ethical approval | DER | This study was performed in line with the principles of the Declaration of Helsinki. Trial registration number: 407-16 with approval from the local ethical committee (Ethikkommission der Medizinischen Fakultät der LMU München). | PMC10066138 | |
Informed consent | Informed consent was obtained from all individual participants included in the study. | PMC10066138 | ||
References | PMC10066138 | |||
Background | disability, chronic mental illness, Obsessive-compulsive disorder, OCD | Obsessive-compulsive disorder (OCD) is a common and chronic mental illness with a high rate of disability. Internet-based cognitive behavioral therapy (ICBT) makes online treatment available to patients and has been shown to be effective. However, 3-arm trials on ICBT, face-to-face cognitive behavioral group therapy (CBGT), and only medication are still lacking. | PMC10248767 | |
Objective | OCD | This study is a randomized, controlled, assessor-blinded trial of 3 groups for OCD: ICBT combined with medication, CBGT combined with medication, and conventional medical treatment (ie, treatment as usual [TAU]). The study aims to investigate the efficacy and cost-effectiveness of ICBT related to CBGT and TAU for adults with OCD in China. | PMC10248767 | |
Methods | Obsessive-Compulsive, OCD | SECONDARY | In total, 99 patients with OCD were selected and randomly assigned to the ICBT, CBGT, and TAU groups for treatment for 6 weeks. The primary outcomes were the Yale-Brown Obsessive-Compulsive Scale (YBOCS) and the self-rating Florida Obsessive-Compulsive Inventory (FOCI), compared at baseline, during treatment (3 weeks), and after treatment (6 weeks), to analyze efficacy. The secondary outcome was the EuroQol Visual Analogue Scale (EQ-VAS) scores of the EuroQol 5D Questionnaire (EQ-5D). The cost questionnaires were recorded to analyze cost-effectiveness. | PMC10248767 |
Results | Repeated-measures ANOVA was used for data analysis, and the final effective sample size was 93 (ICBT: n=32, 34.4%; CBGT: n=28, 30.1%; TAU: n=33, 35.5%). After 6-week treatment, the YBOCS scores of the 3 groups significantly decreased ( | PMC10248767 | ||
Conclusions | OCD | Therapist-guided ICBT combined with medication is as effective as face-to-face CBGT combined with medication for OCD. ICBT combined with medication is more cost-effective than CBGT combined with medication and conventional medical treatment. It is expected to become an efficacious and economic alternative for adults with OCD when face-to-face CBGT is not available. | PMC10248767 | |
Trial Registration | Chinese Clinical Trial Registry ChiCTR1900023840; https://www.chictr.org.cn/showproj.html?proj=39294 | PMC10248767 | ||
Introduction | obsessive-compulsive, Obsessive-compulsive disorder, depressive, OCD, chronic mental illness, disability | Obsessive-compulsive disorder (OCD) is a common and chronic mental illness with a high rate of disability [Internet-based cognitive behavioral therapy (ICBT) makes online treatment available to patients. ICBT is divided into therapist-guided ICBT and self-guided ICBT. ICBT has the advantages of convenience and time saving, which can solve the problem of uneven distribution of medical resources and make up for the limitations of conventional CBT. The results of meta-analyses have shown that therapist-guided ICBT is as effective as face-to-face CBT (ffCBT) for various mental health conditions [ICBT for OCD has been generally proven to be effective. A randomized controlled trial (RCT) in 2013 showed that ICBT and the iCBT program in book format (bCBT) were more effective than the waiting treatment group (waitlist) in improving the obsessive-compulsive and depressive symptoms of patients with OCD [At present, although the number of international studies on the treatment of OCD with ICBT is gradually increasing, most RCTs conducted only set a waitlist or traditional medicine group to compare with ICBT and do not use ffCBT as the control group. In most cases, these waitlist controls are not restricted to take part in any psychotherapy or physiotherapy other than ffCBT, which introduces irrelevant variables. In addition, many current studies on ICBT for OCD are affected by comorbidities and heterogeneous medications. The latest ICBT research on OCD mainly focuses on children and adolescents, and there is a lack of research on adults. Up to now, there is no research on ICBT for OCD and its health economics analysis of OCD in China. Given these deficiencies, the efficacy and costs of ICBT for OCD in China deserve further research. Considering feasibility and cost-effectiveness, cognitive behavioral group therapy (CBGT) was set as the ffCBT active control group in this study. In a meta-analysis of CBT for OCD, individual CBT showed small and nonsignificant effect sizes (0.17) compared to CBGT and showed a noninferior efficacy of CBGT to individual CBT [The study conducted an RCT to compare the feasibility, safety, efficacy, and cost-effectiveness of ICBT, CBGT, and TAU in patients with OCD. TAU involved the administration of psychotropic medications as usual. Both ICBT and CBGT were combined with medical treatment, and patients in the ICBT or the CBGT group also took psychotropic medications as usual. The study used therapist-guided ICBT because a meta-analysis showed that therapist-guided ICBT has better effects than self-guided ICBT [The study aimed to investigate the efficacy and cost-effectiveness of ICBT related to CBGT and TAU for adults with OCD in China. The study was a noninferiority trial and hypothesized that the efficacy of therapist-guided ICBT is no less than that of face-to-face CBGT and medical treatment for OCD. In addition, ICBT was expected to be more cost-effective due to lower costs of treatment. | PMC10248767 | |
Methods | PMC10248767 | |||
Trial Design | OCD | SECONDARY, RECRUITMENT | The study was a 6-week, assessor-blinded, clinical RCT with patients with OCD allocated 1:1:1 to the ICBT, CBGT, and TAU groups. Primary and secondary outcomes were measured 3 times: at baseline (0 weeks), during treatment (3 weeks), and after treatment (6 weeks). The study was carried out at the Shanghai Mental Health Center in Shanghai, China, and was registered in the Clinical Trial Registry (registration no. ChiCTR1900023840). Recruitment and intervention for the trial started in 2018. | PMC10248767 |
Ethical Considerations | The study adhered to the Consolidated Standards of Reporting Trials (CONSORT) and was approved by the Shanghai Ethical Review Committee (2018-57). | PMC10248767 | ||
Participants | psychiatric, OCD | The study subjects were 99 patients with OCD who were consecutively enrolled from a public psychiatric hospital. Information about the trial was sent to clinicians and advertised on posters in the clinic lobby and the online WeChat public account. Participation was referred by psychiatrists or via self-referral, and both were diagnosed as OCD by psychiatrists at the Shanghai Mental Health Center, China. After that, participants were asked to complete an online screening and a brief phone interview. Suitable participants were invited to take part in a face-to-face psychiatric assessment conducted by trained evaluators on duty to determine inclusion or exclusion. The evaluator used the Mini-International Neuropsychiatric Interview (MINI) [The inclusion criteria were(1) age between 18 and 54 years, (2) being satisfied with the diagnostic criteria for OCD in the | PMC10248767 | |
Interventions | All patients in the 3 groups had taken medication before the start of the experiment, 84.9% (n=79) of the patients had taken medication stably for more than 8 weeks, most of the remaining patients had taken medication stably for less than 8 weeks, and a few patients had discontinued medication before enrollment. The types of medications were SSRIs, and the types/doses were not changed during the study. | PMC10248767 | ||
CBGT Intervention | The CBGT group was headed by a nationally registered therapist who had received systematic training. The group was closed and homogeneous, and all face-to-face sessions were audio-recorded to ensure that therapists adhered to the treatment manual. Each subgroup included 6-8 patients, who were treated twice a week for a total of 12 treatments, each 120 minutes long, which lasted 6 weeks. A professional group cognitive therapist supervised this group during treatment. The treatment location was the group psychotherapy room of the Shanghai Mental Health Center. The treatment room was not changed during the treatment period.The structure, content, and number of treatments followed the For handling other special situations, patients who were absent from a certain treatment for some reason were informed of the homework via telephone and email, and those who had difficulty completing the homework could listen to the recording with the researcher for the retrospective study. Patients were deemed to have dropped out of the study if they were absent 3 times in total. | PMC10248767 | ||
TAU Intervention | sleep disorders, OCD | The TAU group was treated with only medication. The medication interventions of the 3 groups were under the charge of an associate chief psychiatrist, who was unaware of the grouping of patients. The medicines used for the treatment of OCD in this study were SSRIs approved by the State Food and Drug Administration (SFDA). The medication treatment lasted for 6 weeks. Patients with sleep disorders could use benzodiazepines in combination, but benzodiazepines should not be taken continuously for more than 2 weeks, and other psychotropic medicines were not used in combination. The medicines used in this study were commonly used in the clinic, which had good safety and fewer side effects. The evaluations of patients’ side effects and adverse information by an outpatient doctor were collected regularly. If patients failed to comply with the agreement and stopped the medicines by themselves, they were deemed to have withdrawn from the study. | PMC10248767 | |
Outcome Measures | Obsessive-compulsive | ADVERSE EVENTS | The demographic data of the 3 groups were collected during the enrollment assessment. Obsessive-compulsive symptoms, the quality of life, and costs were collected 3 times: at baseline, during treatment (3 weeks), and after treatment (6 weeks). All assessments at baseline were offline, and subsequent assessments in the ICBT and TAU groups were conducted online. In addition, the study collected process indexes and recorded adverse events to assess feasibility and safety. The process indexes included the attendance rate, dropout rate, homework completion, and subjective satisfaction of patients. | PMC10248767 |
Primary Outcome | Obsessive-compulsive | Obsessive-compulsive symptoms were measured using a masked assessor–rated YBOCS [ | PMC10248767 | |
Secondary Outcome | The quality of life was measured using the EQ-VAS score of the EQ-5D [ | PMC10248767 | ||
Cost Data | confusion | The study designed the Sinicized Cost Questionnaire based on Trimbos and the Institute of Medical Technology Assessment Cost Questionnaire for Psychiatry [Direct costs included registration, psychological treatment, medication, and rehabilitation. Indirect costs included transportation expenses, accommodation expenses, food expenses, medical and health care expenses due to illness, and the loss of productivity for patients and their families. To avoid confusion regarding the inability to work/study due to illness with unemployment/dropout, only the time spent in the hospital for consultation and treatment was counted as the number of days the patient was unable to work/study.The cost-effectiveness analysis (CEA) method was used to measure the spending of the 3 groups. The results of the total cost divided by the reduction in the YBOCS total score reflected the cost required to obtain each unit of curative effect. | PMC10248767 | |
Sample Size | The statistical method suitable for this study was 2-way (1 within-subject and 1 between-subject factor) repeated-measures ANOVA. According to the theoretical considerations [and the minimum sample size was nl=n2=n3=23. Considering the dropout rate and clinical operability, the TAU, ICBT, and CBGT groups should each have had 33 patients, so finally, 99 patients meeting the criteria were included. | PMC10248767 | ||
Randomization and Blinding | BLIND | Random sequences were generated in Microsoft Excel with the RAND function, and all eligible patients were randomized 1:1:1 to the ICBT, CBGT, and TAU groups. The evaluators were blind to the patients’ treatment. At the same time, patients were asked not to mention the psychotherapeutic conditions to the evaluator during assessment. The arrangement of the time and location of the assessments for the 99 patients was the responsibility of the coordinator, who did not disclose the grouping of patients. | PMC10248767 | |
Statistical Analysis | SD | DISEASE | Statistical data were analyzed with SPSS 25.0 (IBM Corporation). All outcome analyses were conducted according to the intention-to-treat principle, and the missing data were dealt with using conditional mean imputation [The study repeated the analysis for the primary outcome using 2 different approaches as sensitivity analyses to assess the robustness of our conclusions. The first approach was complete case analysis. In this situation, only cases that completed all the follow-up measures (n=80, 86.0%) were analyzed, while cases with missing values were removed. The second approach was analysis with the addition of covariates. In this case, demographic variables, such as age, years of education, age at first onset, and total duration of the disease, were included as covariates in the repeated-measures ANOVA.In cost analyses, the total cost was the sum of direct and indirect costs. The total direct/indirect cost of each group was obtained by adding the direct/indirect cost provided by each group. To quantify the cost of lost productivity in the indirect cost, the study averaged China's 2018 annual per capita income (renminbi [RMB] 27,996 [US $4235.40]) for 365 days (RMB 76.70 [US $11.60]) and then multiplied it by the number of patient working days lost. The mean (95% CI) and SD of costs were described. The cost-effectiveness ratio (CER) for each group was the result of the total cost divided by the total reduction in the YBOCS score, which was the amount of money spent for each reduction in the YBOCS score. The incremental cost-effectiveness ratio (ICER) took the cost of the group with the least expenditure as the standard to compare the additional expenditure of the other groups per reduction in the YBOCS score. The yuan (RMB) is the national currency of the People’s Republic of China, and the average exchange rate was US $1.00=RMB 6.61 for 2018. | PMC10248767 |
Results | PMC10248767 | |||
Feasibility and Safety | anxiety, vertigo | ADVERSE EVENTS | In the ICBT group, 7 (21.2%) of 33 patients dropped out (n=3, 42.9%, men): 1 (14.3%) patient lost contact before the start of treatment, 3 (42.9%) patients discontinued the medication because their condition improved, and 3 (42.9%) patients withdrew because they could not receive online treatment. In the CBGT group, 7 (21.2%) of 33 patients dropped out (n=4, 57.1%, men): 5 (71.4%) patients dropped out because they could not wait until the treatment group was assembled, 1 (14.3%) patient withdrew because they discontinued medication themselves, and 1 (14.3%) female patient dropped out due to the lack of female patients in the group. In the TAU group, 5 (15.2%) patients dropped out (n=3, 60.0%, men) because they discontinued medication themselves. There was no statistically significant difference in the dropout rate among the 3 groups (In conclusion, a total of 19 (19.2%) of 99 patients dropped out from the 3 groups during treatment. Of them, 6 (31.6%) patients did not participate in the treatment (n=5, 83.3%, in the CBGT group; n=1, 16.7%, in the ICBT group) and had no baseline data. The remaining 13 (68.4%) patients dropped out in the middle of treatment (n=2, 15.4%, in the CBGT group; n=6, 46.2%, in the ICBT group; and n=5, 38.4%, in the TAU group). According to the intention-to-treat principle, we replaced the of these 13 (68.4%) patients with the mean imputation, and the final effective data of 93 patients (ICBT: n=32, 34.4%; CBGT: n=28, 30.1%; TAU: n=33, 35.5%) were considered.The results of the 7-level satisfaction scale evaluation of the 3 groups were as follows:ICBT group: 3-week mean 5.73 (SD 0.96); 6-week mean 5.77 (SD 0.82)CBGT group: 3-week mean 5.19 (SD 0.94); 6-week mean 5.30 (SD 0.97)TAU group: 3-week mean 4.86 (SD 0.76); 6-week mean 4.67 (SD 0.81)During the treatment (3 weeks), the satisfaction degree of the TAU (Among the 12 treatments, there was no significant difference between the ICBT (18.59%) and CBGT (13.14%) groups in the absence rate (This study recorded 2 adverse events: 1 (3.1%) patient in the ICBT group expressed anxiety and vertigo symptoms during the reading text of module training and finally terminated the treatment and withdrew from the study, while 1 (3.6%) female patient in the CBGT group felt uncomfortable and withdrew from the study due to the lack of female members in the group. No serious adverse events occurred in this study. | PMC10248767 |
Secondary Outcome | OCD, obsessive-compulsive disorder | The VAS scores in the EQ-5D scale for the 3 groups had no significant differences at baseline (Secondary outcome of VAS in a study of the effect of ICBT vs CBGT vs TAU on OCD symptoms in adults. CBGT: cognitive behavioral group therapy; ICBT: internet-based cognitive behavioral therapy; OCD: obsessive-compulsive disorder; TAU: treatment as usual; VAS: visual analogue scale. | PMC10248767 | |
Health Economics Analyses | PMC10248767 | |||
Therapist Time Consumption | This study did not include the time of therapists for cost calculation but collected the total time of the therapists occupied by the 3 groups of interventions. The results showed that patients in the ICBT group consumed a total of 1078 minutes of the therapist’s time during the 6-week treatment, with an average of 32.67 (SD 13.37) minutes per person; the CBGT group consumed a total of 2880 minutes of the therapist’s time during the 6-week treatment, with an average of 102.86 (SD 0) minutes per person. Compared to the CBGT group, the ICBT group saved a total of 1802 minutes of the therapist’s time, with an average of 70.19 (SD 13.37) minutes saved per person. | PMC10248767 | ||
Sensitivity Analysis | The study performed complete case analysis (n=80, 86.0%) and analysis with the addition of covariates, and the results of the 2 sensitivity analyses were consistent with those of the primary analyses, suggesting the robustness of our conclusions. | PMC10248767 | ||
Discussion | PMC10248767 | |||
Principal Findings | YBOCS, anxiety, vertigo, obsessive-compulsive symptoms, assessor-rated, OCD | ADVERSE EVENTS, BLIND | This study was an RCT of ICBT, CBGT, and conventional medical treatment for OCD in China, which aimed to evaluate the efficacy and cost-effectiveness of therapist-guided ICBT for Chinese patients with OCD. All 3 groups had curative effects and improved quality of life after treatment for 6 weeks, and the ICBT group was more cost-effective than the other groups. The satisfaction of patients was high, and there were no serious adverse events.In terms of efficacy, the significant efficacy of SSRIs was consistent with the results shown in earlier studies [A difference between the results of the YBOCS and FOCI was found in this study. After treatment (6 weeks), the FOCI score of the ICBT and CBGT groups was significantly lower than that of the TAU group, while this difference was not detected in the YBOCS. It was probably because the YBOCS is an assessor-rated scale, while FOCI is a self-rating scale. Patients may have more acute observations of the changes in their own obsessive-compulsive symptoms and experience. This might be more sensitively reflected in the FOCI score after ICBT/CBGT rather than the blind assessor–rated YBOCS. In addition, the satisfaction degree of treatment in the ICBT/CBGT group was higher than that in the TAU group, which might also affect the self-rating scores.With regard to feasibility, the results showed that the TAU group had the lowest dropout rate, and the ICBT group had the same dropout rate as the CBGT group. Half of the patients dropped out in the ICBT group due to discomfort with reading text on an electronic screen. Completing therapy and homework by reading and typing on the keyboard might be unfriendly to some people, especially older patients. A patient in the ICBT group withdrew from the study because of anxiety and vertigo symptoms during training and reading. It was difficult for ICBT when the patient was not accustomed to using the computer, lacked motivation for treatment, or had too severe symptoms. Patient compliance did correlate with treatment modality, and some patients who dropped out reported that they were not used to online therapy. A previous paper indicated that a single human-computer interaction might lack face-to-face treatment, resulting in decreased compliance of patients during treatment [Health economics results showed that ICBT is significantly less expensive than CBGT and was the most cost-effective option of the 3. The cost savings of the ICBT group might be achieved by less transportation expenses, accommodation expenses, food expenses, and productivity loss because patients in the ICBT group could choose their own ERP practice time at home without extra transportation, accommodation, and work absence compared to the CBGT group. From health organizational perspectives (ie, therapist time) due to the online technology and the therapist-guided self-help mode, compared to the CBGT group, the ICBT group saved time for therapists, with an average of 76.43 minutes per person, which may help solve the human resource shortage in mental health services in China. Nowadays, the burden on mental health in various countries is increasing. For example, the United States spent more than US $300 billion on mental health each year [ | PMC10248767 |
Limitations | This study has a few limitations. First, the dose and duration of patients’ SSRI treatment before enrollment were not clearly recorded, which were variables that could be included in the analysis. In addition, 8 weeks should be used as a standard for stable medication to screen subjects to reduce the impact of medication duration on the trial. Furthermore, the mean imputation may underestimate the variability of the data, although the sensitivity analysis of complete cases (n=80) showed consistent results with the primary analyses. In terms of health economics, it would be more comprehensive to include the cost of treatment space and therapists’ time in the cost analyses in the future. For example, CBGT requires renting treatment rooms and takes more time of therapists, which may lead to more costs for CBGT.Based on the results of the equivalent efficacy of ICBT and CBGT, researchers and physicians can provide ICBT as a treatment option for patients in clinical practice, try to enhance the interactivity of ICBT courses or develop a combination of online and offline treatment methods, and gradually carry out some in-depth research in the future. For example, researchers should develop and validate the feasibility and efficacy of combined online and offline treatments. In addition, researchers can try to explore ICBT based on individualized assessment and make better use of the advantages of the online form through a step care model. Multicenter studies need to be carried out in the future. In addition, some studies have focused on the long-term efficacy of ICBT [Second, this study only focused on therapist-guided ICBT and did not explore self-guided ICBT. The latest research has verified the feasibility of self-guided ICBT (unguided ICBT) [ | PMC10248767 | ||
Conclusion | Psychotic Disorders, OCD | Therapist-guided ICBT combined with medication is as effective as face-to-face CBGT combined with medication for OCD. ICBT combined with medication is more cost-effective than CBGT combined with medication and conventional medical treatment. It is expected to become an efficacious and economic alternative for adults with OCD when face-to-face CBGT is not available.This work was supported by the National Natural Science Foundation of China (82230045, 81771460), the General project of Shanghai Municipal Health Commission (202140054), the Academic Leader of Health Discipline of Shanghai Municipal Health Commission (2022XD025), the Shanghai Jiaotong University "star of Jiaotong University" medical engineering cross research fund key project (YG2021ZD28), the Shanghai Science and Technology Committee Project (20DZ2253800), and the Key Laboratory of Psychotic Disorders (13dz2260500).Conflicts of Interest: None declared.CONSORT-eHEALTH checklist (V 1.6.1). | PMC10248767 | |
Abbreviations | Obsessive-Compulsive | cognitive behavioral group therapycognitive behavioral therapyCognitive Behavioral Therapy Chinacost-effectiveness ratioEuroQol 5D QuestionnaireEuroQol Visual Analogue Scaleexposure and response preventionface-to-face CBTFlorida Obsessive-Compulsive Inventoryinternet-based cognitive behavioral therapyincremental cost-effectiveness ratioleast significant differenceobsessive-compulsive disorderrenminbirandomized controlled trialselective serotonin reuptake inhibitortreatment as usualVisual Analogue ScaleYale-Brown Obsessive-Compulsive Scale | PMC10248767 | |
Background | depression | The prevalence of depression is increasing in Japan. Pharmacists play an important role in helping patients use medicines effectively. Several studies had investigated the impact of community pharmacists on patient adherence to antidepressant therapy, and their results indicated that further study was warranted. | PMC9951417 | |
Methods | Depressive, adverse drug reactions, unipolar depression | MAY, ADVERSE DRUG REACTIONS | This study was conducted from June 2019 to May 2020 using a cluster non-randomized, open-label, parallel-group design. Four community pharmacy stores in Osaka and Hyogo Prefectures, Japan, participated in the study, and enrolled patients with unipolar depression. In the intervention group (IG), patients received cognitive behavioral therapy (CBT)-based medication support, and their medication adherence and adverse drug reactions were monitored by telephone. In the control group (CG), the pharmacists engaged in routine interactions with the study participants. Before participating in this study, the intervention-group pharmacists attended a 5-hour training session on CBT-based medication support. The primary outcome of this study was medication adherence, assessed using the Drug Attitude Inventory (DAI)-10. Secondary outcomes included the changes from baseline at 6 months in the following variables: the Patient Health Questionnaire (PHQ)-9 total score, the EQ-5D-5 L (Euro-QOL 5 dimensions 5 levels) score, patient satisfaction, and the Pharmacists’ Confidence Scale about Medication Consultation for Depressive Patients (PCMCD) score. | PMC9951417 |
Results | Four pharmacies (two in IG and two in CG) completed the intervention period. Results were obtained from 19 patients in the IG and 12 patients in the CG. In the IG, the mean DAI-10 score increased from 4.941 at baseline to 6.105, the mean PHQ-9 score decreased from 9.263 to 8.625, and the mean patient satisfaction score increased from 39.947 to 42.211. In the CG, the mean DAI-10 score decreased from 6.333 to 4.167, the mean PHQ-9 score increased from 9.333 to 12.923, and the mean patient satisfaction score decreased from 38.929 to 38.167. | PMC9951417 | ||
Conclusion | depressed | CBT-based medication support provided by community pharmacists may improve patient medication adherence to antidepressant therapy and symptoms. Such support can be expected to facilitate better treatment of depressed patients and may also allow the duration of treatment to be shortened. | PMC9951417 | |
Trial registration | UMIN000037954, Date of first registration: 17/06/2019. | PMC9951417 | ||
Supplementary information | The online version contains supplementary material available at 10.1186/s12888-023-04602-5. | PMC9951417 | ||
Introduction | major depression, cognitive distortions, depressed, depression, Depression | ADVERSE DRUG REACTIONS | The World Health Organization estimated that 264 million people had depression worldwide in 2017, and the global burden of depression is on the rise [Depression generally require a long-term treatment. Treatment of major depression typically consists of three distinctive phases: acute, continuation, and maintenance [Patient adherence to the antidepressant regimen is a critical factor in effective management of symptoms. However, studies show that antidepressant regimens are not sufficiently complied with in many parts of the world. According to Masand, obstacles to adequate antidepressant therapy may involve issues that are attributable to physicians (e.g., inadequate patient education), medications (e.g., adverse drug reactions, delayed onset of action), and patients (poor motivation to continue therapy, concerns about treatment) [Against this background, we hypothesize the following.
Taming their cognitive distortions would help patients adhere to their medication and treatment regimens and alleviate their illnesses.Patient satisfaction with pharmacy services will increase as a result of the aforementioned supports.Pharmacists’ confidence in dealing with depressed patients will increase as they gain experience with the interventions being introduced in this study. | PMC9951417 |
Objectives | unipolar depression | The objective of this study was to investigate whether CBT-based medication support by the community pharmacist would improve the medication adherence, medical status, satisfaction towards the services of pharmacy of patients with unipolar depression. Another objective was to observe changes in pharmacists’ confidence in dealing with patients after gaining experience with the interventions introduced in the study. | PMC9951417 | |
Methods | PMC9951417 | |||
Study design | MAY | This study was a cluster non-randomized, open-label, parallel-group, controlled study, based on the transparent reporting of evaluations with nonrandomized designs statement. This study was conducted from June 2019 to May 2020. Four community pharmacies in Osaka and Hyogo Prefectures, Japan, participated. This study was registered with the University hospital medical information network (UMIN) center (UMIN000037954, Date of first registration: 17/06/2019). | PMC9951417 | |
Participants | PMC9951417 | |||
Pharmacists inclusion criteria | depressive | The inclusion criteria for pharmacists included (i) employed at a community pharmacy that accepts prescriptions mainly from psychosomatic medicine and psychiatry, (ii) routinely provides medication to depressive patients, and (iii) has received an explanation of the purpose of the research from the Investigator, understands the explanation, and wishes to participate of their own will. The type and length of the pharmacists’ work experiences were not taken into account. No particular exclusion criteria were defined. Volunteering pharmacists were explained about the objectives and other details of this study verbally and through written documents, and signed the informed consent form before participating in this study. Before the start of the study interventions, the study investigators met the psychosomatic medicine specialists whose prescriptions were processed by the participating pharmacies, and explained the objectives and other details of this study to obtain their consent to assist with this study. | PMC9951417 | |
Patients inclusion criteria | unipolar depression | RECRUITMENT | Patients were eligible for inclusion if they were (i) diagnosed with unipolar depression, (ii) currently receiving antidepressant prescriptions, and (iii) visiting the participating pharmacy for prescription refills. As part of the patient recruitment process, the participating pharmacist contacted the prescribing physician, and checked the diagnosis of the consenting patient. | PMC9951417 |
Patients exclusion criteria | dementia, schizophrenia, maniac | Exclusion criteria included (i) patients suspected of having maniac episodes, (ii) diagnosis of schizophrenia, (iii) diagnosis of dementia, and (iv) patients not visiting the pharmacy in person. Patients were eligible if their pharmacy visit was accompanied by a helper. | PMC9951417 | |
Allocation | This was a non-randomized study. One of the study investigators (AF) allocated the participating pharmacies to the intervention and control groups. For this purpose, the prescribing practitioners’ receptiveness for the pharmacist interventions, the personal relationship between the pharmacist and patients, and similarity in pharmacy size between the two groups were taken into consideration. | PMC9951417 | ||
Intervention group | adverse drug reactions | ADVERSE DRUG REACTIONS | In the intervention group, patients received CBT-based medication support, and their medication adherence and adverse drug reactions were monitored by telephone calls. | PMC9951417 |
Control group | Control-group pharmacists used their routine interactions with their patients. | PMC9951417 | ||
Educational program | depressed | Before participating in this study, pharmacists attended a 5-hour training course on CBT-based medication support. This training program was developed by Tanuma et al. with a focus on community pharmacists [
The commentary on building basic communication with patients was shortened.The role-playing cases were limited to depressed patients.Added detailed commentary on how to deal with depressed patients.The role-plays were conducted in pairs of three, with the patient, pharmacist, and observer roles, respectively. The person playing the role of the patient responded to the person playing the role of the pharmacist according to his or her preferences. The concept is that the pharmacist uses cognitive reconstruction skills to elicit evidence from the patient’s thoughts and moods, guiding the patient to recognize his or her own rebuttal to the evidence. Observers provide feedback after the role-play. After the role-play, each of the three participants discussed their impressions, what the person who played the role of the pharmacist aimed to achieve, and areas for improvement. The program also uses an original thought record table, and the pharmacists learned how to use it. An example of a role-play and a thought record table are provided in Supplemental Figs. 1 and 2. | PMC9951417 | |
Outcomes | PMC9951417 | |||
Primary outcome | The primary outcomes of this study were medication adherence. Medication adherence was evaluated using the Drug Attitude Inventory (DAI)-10 questionnaire (Japanese version).The DAI-10 questionnaire is a 10-item self-report scale widely used to evaluate patients’ attitudes towards medication. Respondents answer each question by choosing true or false. Each item is scored 1 or − 1, with the total score ranging from − 10 (very poor attitude) to + 10 (best possible attitude). A positive total score indicates a positive subjective response (adherent), whereas a negative total score indicates a negative subjective response (non-adherent) [ | PMC9951417 | ||
Secondary outcomes | SECONDARY | The secondary outcomes of this study were assessed using the Patient Health Questionnaire (PHQ)-9, patient satisfaction [ | PMC9951417 | |
Statistical analysis | REGRESSION | The differences in the study variables between the start (baseline) and end of the study (6-months post-baseline) were evaluated in the per-protocol set. The Between-group differences in the 6-month changes in DAI-10, PHQ-9, and EQ-5D-5 L and PCMCD scores were compared using the unpaired t-test. To examine the factors that influence the DAI-10 scores and their strengthes, a multiple regression analysis was performed with the change in the DAI-10 as the dependent variable.All statistical analyses were performed using the IBM SPSS Statistics Version 26 (IBM Japan, Tokyo). | PMC9951417 | |
Risk management | We had cognited following latent risks in this study;
worsening the relationship between the patients-pharmacist or physician-pharmacist due to the failure or wrong way of CBT-based medication support.1 might worsen the patient’s symptoms.We explained these to the pharmacist in advance, and instructed to exclude the patient from intervention if these happened. | PMC9951417 | ||
Results | PMC9951417 |
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