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Results | PMC10580601 | |||
Participants | arthritis | ARTHRITIS | Initially, 120 eligible participants were recruited in this study and participated in SCET. Of these, 14 were excluded due to poor attendance < 70%, and 106 participants completed pre- and post-intervention measures and were included in data analysis. Four of the 106 participants were diagnosed with arthritis, and 3 of the 4 were taking medication for arthritis. SST performance when tasked with BBT and FD performance when tasked with BBT were significantly improved in all participants who participated in SCET (SST:
Participant characteristicsNote. Education, years of formal education. MMSE, Mini-Mental Status Examination; MoCA, Montreal Cognitive Assessment. Based on the result of independent | PMC10580601 |
Responsiveness | Table
Responsiveness to simultaneous cognitive-exercise training across two groupsNote. ES, effect size; SRM, standardized response mean; Crt No, corrected number = correct responses -incorrect responses; No, number of blocks | PMC10580601 | ||
MCID | The anchor-based MCID was calculated as the average score change of participants whose improved score was equal to or greater than one-half of the SD of MoCA at pre-intervention. One-half of the SDs of MoCA were 0.69 and 2.05 for the CH and the CI groups, respectively (Table
Dual-task measures across two groupsNote. M, mean; SD, standard deviation; MoCA, Montreal Cognitive Assessment; Crt No, corrected number = correct responses - incorrect responses; No, number of blocks
Distribution- and anchor-based MCID of the two dual-task measures across two groupsNote. Crt No, corrected number = correct responses - incorrect responses; No, number of blocks | PMC10580601 | ||
Discussion | cognitive auditory discrimination | To the best of our knowledge, this study is the first to estimate the responsiveness and MCID of dual task performance involving cognition and hand function for older adults with and without CI after SCET. Among the sample of CH adults, there were small yet consistent intervention effects to the cognitive components of different dual task paradigms; the effect on the exercise task was stronger when paired with the cognitive mental arithmetic task than when paired with cognitive auditory discrimination task.This study suggests that the dual tasks combining cognition and hand function in the CH group show fair responsiveness to the SCET intervention. In the CH group, the dual task measures showed small responsiveness, except BBT performance when tasked with FD; in the CI group, only FD performance when tasked with BBT showed small-to-medium responsiveness. Both dual tasks may represent different levels of difficulty in successful execution. The dual task of SST and BBT required higher cognitive demand that SST involves working memory [For the CH group, there may be a ceiling effect [For participants in the CI group, the dual task of SST and BBT may be too challenging to be responsive to change and a floor effect [The estimates of distribution-based MCID are greater than those of anchor-based MCID of all dual task measures in both groups (distribution-based MCIDs: CH group: 1.20–5.99; CI group: 1.24–7.69; anchor-based MCIDs: CH group: 0.32–3.77; CI group: 0.67–1.47). The observed discrepancy between the two methods may be due to the different ways in which changes are detected. The distribution-based approach measures changes by calculating the statistical properties of the observed sample, including participants who improved or declined after the intervention. The anchor-based approach uses an external criterion is used as a reference for measuring changes [Our findings indicate that SST performance when tasked with BBT may serve as a MCID index for the CH group following SCET, while FD performance when tasked with BBT may serve as a MCID index for the CI group following SCET. Participants in the CH group achieved meaningful change along with a greater MCID estimate of SST performance when tasked with BBT (MCIDs = 2.09–2.36) than those in the CI group (MCIDs = 0.67–1.24). As noted earlier, the dual task of SST and BBT requires higher cognitive demand and is more complex than the dual task of FD and BBT. Accordingly, the findings suggest that participants in the CH group had better cognitive abilities and potential for improvement in the progress of cognitive performance and may have greater potential improvement from the SCET compared to those in the CI group. In terms of FD performance when tasked with BBT, participants in the CI group achieved meaningful change along with a greater MCID estimate (MCIDs = 1.47–2.18) than those in the CH group (MCIDs = 1.00-1.20). It is possible that the CI group had worse baseline FD performance when tasked with BBT (mean = 13.60) and more room to be improved than those in the CH group (mean = 15.79) when performing the easier dual task requiring the fundamental cognitive ability of sustained attention.Given the small responsiveness of BBT performance when tasked with SST and with FD and the huge ranges between distribution- and anchor-based MCID estimates for both groups, BBT performance when tasked with SST and with FD were not suggested to be used as a MCID index after SCET for either group. Also, considering that the SCET intervention did not demonstrate significant improvements in BBT performance among older adults with CI, it may be worthwhile to explore alternative physical tasks such as marching on the spot or performing upper/lower limb workouts with resistance in future dual task paradigms for this specific population.The results of the 12-week SCET intervention in a group-based setting, combining various cognitive tasks with multiple exercises for a total dose of 1080–1440 min, indicate improvements in attention (FD) and working memory (SST) performance during dual task conditions, as well as EFs (dual task performance) in CH older adults. These findings are aligned with previous SCET studies that employed multicomponent cognitive training (involving attention, memory, arithmetic, and language) combined with physical exercises (aerobic and resistance exercises) and reported improved attention and working memory performance in CH older adults [In the CI group, attention showed improvement, which is consistent with previous research using multicomponent SCET [ | PMC10580601 | |
Study limitations | hearing loss | HEARING LOSS, HARD OF HEARING | This study has some limitations that should be noted. Firstly, the sample size was small, and there was an uneven distribution of sexes, which may affect the generalizability of our results to other populations. The psychometric properties vary, which depends on participant characteristics. Therefore, our findings are more properly generalizable to community-dwelling female older adults with or without CI than other populations. Secondly, only participants who attended more than 70% of the sessions were included, limiting the generalizability to those with high motivation for participation. Thirdly, the participants’ medical conditions were collected through self- or informant-report. Based on this information, participants with a diagnosis of hearing loss or hard of hearing were excluded from the study. However, no formal assessment was conducted to determine the hearing status of the participants. Fourthly, we did not consider the significant difference in years of formal education between the two groups when analyzing dual task performance, as we did with the MoCA score. Education level can influence cognitive abilities and task performance, and it should have been considered to control for potential confounding effects. Lastly, participants were grouped into two categories based on their pre-intervention MoCA score, but CI is diverse and can have varying levels. Future research with a larger sample size should explore psychometric properties for individuals with different levels of CI. | PMC10580601 |
Conclusions | This study suggests that when evaluating the benefits of SCET for CH older adults and those with CI using responsiveness and MCID of dual tasks involving cognition and hand function, SST performance when tasked with BBT and FD performance when tasked with BBT should be used as indices, respectively. A change in SST performance when tasked with BBT between 2.09 and 2.36 corrected numbers is considered meaningful for CH older adults. In comparison, a change in FD performance when tasked with BBT between 1.47 and 2.18 corrected numbers is considered a meaningful change for CI older adults. | PMC10580601 | ||
Acknowledgements | RECRUITMENT | We thank all participants who participated in this study and all occupational therapists who helped with recruitment. The project was funded by Healthy Aging Research Center at Chang Gung University [EMRPD1M0411], Chang Gung Medical Research Center at Chang Gung Memorial Hospital [CMRPD1L0193], Chang Gung Memorial Hospital [BMRPJ29], and the Ministry of Science and Technology, Taiwan [MOST 111-2314-B-182-039-MY3]. | PMC10580601 | |
Authors’ contributions | All authors contributed to the study conception and design. Material preparation and data collection were performed by ICChuang and KCC. Data analysis was performed by ICChen and CYW. The first draft of the manuscript was written by ICChen and CYW, and all authors commented on previous versions of the manuscript. All authors have read and agreed to the published version of the manuscript. | PMC10580601 | ||
Funding | This project was partly supported by the Healthy Aging Research Center at Chang Gung University [EMRPD1M0411], Chang Gung Medical Research Center at Chang Gung Memorial Hospital [CMRPD1L0193], Chang Gung Memorial Hospital [BMRPJ29], and the Ministry of Science and Technology, Taiwan [MOST 111-2314-B-182-039-MY3]. | PMC10580601 | ||
Data Availability | The datasets used and/or analyzed during the current study are available from the corresponding author on reasonable request. | PMC10580601 | ||
Declarations | PMC10580601 | |||
Ethics approval and consent to participate | The study was conducted in accordance with the Declaration of Helsinki and approved by the Research Ethics Committee of National Taiwan University (201912EM016) for studies involving humans. Before conducting this study, all participants were provided a written and oral explanation of the study protocol. After written informed consent was obtained, participants started involving research participation. Since this article does not include identifiable data of any participants in any form, consent for publication is not applicable here. | PMC10580601 | ||
Consent for publication | Not applicable. | PMC10580601 | ||
Competing interests | The authors declare no competing interests. | PMC10580601 | ||
References | PMC10580601 | |||
Background | DISORDERS | The Unified Protocol (UP) is a transdiagnostic intervention based on emotional regulation for the treatment of emotional disorders. Its application in individual and group formats has been studied worldwide, obtaining similar results to specific protocols but with a lower drop-out rate and improving the cost–benefit ratio, since a larger number of patients can benefit from it. Moreover, the inclusion of digital technologies in psychotherapy aims to improve the accessibility of treatments, especially since the pandemic of COVID-19 that forced the implementation of treatments through teletherapy increasing its use. To date, no studies have been carried out in Argentina on the application of the UP in a group format and through teletherapy. The aim of the present study is to evaluate the efficacy of the UP in a group format and through teletherapy in the Argentine population. | PMC10588128 | |
Methods | Depression, Anxiety | SECONDARY, POSITIVE | A parallel-group, controlled, randomized trial, with pre-post and repeated follow-up measures intergroup design will be conducted. One hundred eighty patients will be randomized to one of the following conditions: an online, group-based UP intervention or a waiting list. The Beck Depression Inventory-II and the Beck Anxiety Inventory will be used to compare primary outcomes and the Beck Hopelessness Scale, Difficulties in Emotion Regulation Scale, Positive Affect and Negative Affect Scale, and Multicultural Quality of Life Index will be administered for secondary outcomes at baseline, post-intervention, and 3 months follow-up. Ad-hoc questionnaires will be used to assess patients’ experiences and treatment satisfaction. | PMC10588128 |
Discussion | depressive | The purpose of this trial is to evaluate the efficacy of the online and group application of the UP in the Argentine population, as well as to evaluate the patient’s experience and satisfaction with the treatment. It is expected that the findings of this study will be useful in reducing anxious and depressive symptomatology, will allow us to adapt the UP to our culture, and will improve accessibility to treatment. | PMC10588128 | |
Trial registration | ClinicalTrials.gov NCT05275322. Registered on 11 March 2022.
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Keywords | PMC10588128 | |||
Administrative information |
Investigator-initiated clinical trial:C. J. Garay (Principal Investigator)cristiangaray@psi.uba.ar | PMC10588128 | ||
Introduction | PMC10588128 | |||
Background and rationale {6a} | DISORDERS | Research has established emotional disorders as the mental disorders with the highest prevalence worldwide [These disorders involve significant economic costs for public health given their high prevalence and chronicity. Moreover, access to evidence-based treatments in Argentina is often difficult given the lack of therapists trained in their application [Given the huge gap in access to treatments, the use of technology in mental health and psychological therapy is expected to increase access to effective treatments in populations that do not have access to these treatments. During the last few years, the application of teletherapy in different disorders has been studied and similar outcomes to face-to-face treatments have been obtained [The application of the UP in group and face-to-face formats has been studied around the world [ | PMC10588128 | |
Objectives {7} | anxiety, depressive disorders | The aim of the present study is to evaluate the efficacy of the UP in online and group format in the Argentine population. For this purpose, the following research questions have been formulated:Will the Unified Protocol delivered in an online and group format be more effective than the absence of treatment (control group) for anxiety and depressive disorders in the Argentine population?What are the experiences of patients in online and group therapy? | PMC10588128 | |
Trial design {8} | anxiety/depressive symptoms | DISORDERS | This is the protocol of a parallel-group, controlled, randomized trial, with a pre-post and repeated follow-up measures intergroup design. This trial is framed in the superiority framework.A two-arm trial is going to be carried out. For this reason, a waiting list has been chosen as a comparator. Participants with low to moderate anxiety/depressive symptoms will be randomly assigned to Group 1: Unified Protocol for Transdiagnostic Treatment of Emotional Disorders (UP) intervention, or Group 2: Wait-List Control group.The assessment will be conducted at three-time points for Group 1: an initial assessment before being randomized (pretreatment; T0), at the end of the intervention (post-treatment; T1), and 3 months after the completion of the intervention (T2). Group 2 will be assessed on T0 and T1. T2 would not be measured in this group since after T1 they will start treatment.CONSORT patient’s flowchart is presented in Fig. CONSORT flow diagram | PMC10588128 |
Methods: participants, interventions, and outcomes | PMC10588128 | |||
Study setting {9} | Our research team will conduct this study at the University of Buenos Aires, in Buenos Aires (Argentina), and will be delivered entirely online. | PMC10588128 | ||
Eligibility criteria {10} | substance abuse disorder, borderline personality disorder, comorbidity, anxiety disorder, agoraphobia, ideation, panic disorder, eating disorders, bipolar disorder, depressive disorder, post-traumatic stress disorder, unipolar depression, dysthymia, psychotic disorders, obsessive–compulsive disorder, DSM-5 | To participate in this study, participants must fulfill the following inclusion criteria: (1) ≥ 18 years old; (2) submit informed consent; (3) agree to participate in all the scheduled sessions; (4) agree to have the sessions recorded (both audio and video) for monitoring purposes; (5) meet criteria for a primary diagnosis of an anxiety disorder (e.g., panic disorder; agoraphobia; social anxiety disorder; generalized anxiety disorder; unspecified anxiety disorder), or unipolar depression (major depressive disorder; dysthymia) according to DSM-5; (6) not being currently receiving other psychological treatment.Exclusion criteria will be the following: (1) comorbidity with bipolar disorder, obsessive–compulsive disorder, post-traumatic stress disorder, psychotic disorders, bipolar disorder, eating disorders, borderline personality disorder, substance abuse disorder; (2) presence of suicidal plans and/or acts or having had suicidal plans and/or acts in the last 12 months; (3) having a suicidal ideation score on the Beck Hopelessness Scale (BHS) ≥ 10; (4) being currently receiving psychological treatment or have received psychological treatment within the last year.All candidates who are not included in the study will be informed of this decision and will be given information on places to seek free treatment. | PMC10588128 | |
Who will take informed consent? {26a} | At the initial screening, participants will receive informed consent from the therapist and will have the opportunity to ask questions about their participation. After that, they will receive the informed consent form and will have to sign it online. | PMC10588128 | ||
Additional consent provisions for collection and use of participant data and biological specimens {26b} | In this study, biological samples will not be collected. Participant data will be used only for the research proposes. | PMC10588128 | ||
Interventions | PMC10588128 | |||
Explanation for the choice of comparators {6b} | The present study aims to evaluate the efficacy of the application of the Unified Protocol in a group and online format in the Argentinean population. A two-arm trial is going to be carried out. For this reason, a waiting list has been chosen as a comparator. | PMC10588128 | ||
Intervention description {11a} | PMC10588128 | |||
Unified Protocol | Emotion-Driven Behaviors, cognitive suppression | SESSION, DISORDERS | The UP focuses on different strategies of emotion regulation to address neuroticism, a common factor in all emotional disorders (ED). This intervention intends to address dysfunctional emotional regulation strategies in participants and encourages the use of more adaptive strategies to promote tolerance to intense negative emotions. Participants will receive online, synchronous group therapy based on the UP model for 10 subsequent weeks, with a duration of 90 min for each meeting. After every session, they will receive the chapter of the UP’s Spanish patient’s workbook [Contents of each session:Session 1:Coordinators’ and participants’ introductions. Session framework. Introduction to the approach and ED. Conceptualization of ED and identification of their own intense emotions, aversive reactions, and avoidance efforts.Session 2:Module 1: Motivation for change and commitment to treatment. Describing issues, goals, and steps to accomplish them. Introduction to change motivation. Decision balance exercise.Session 3:Module 2: Understanding emotions. Introduction to the topic of this session (psychoeducation of emotions). Presentation of the three-component model and introduction to the concept of Emotion-Driven Behaviors (EDBs), as well as the antecedents and consequences of emotional experiences.Session 4:Module 3: Emotional awareness training. Introduction to mindfulness. Non-judgment emotional awareness exercises will be carried out during the session, and participants will receive afterwards by email with the taped audio so as to do it during the week. Introduction to emotional induction and practicing mindfulness when facing stimuli that trigger emotions (videos/audio). Introduction to anchoring in the present.Session 5:Module 5: Cognitive flexibility. Introduction to cognitive flexibility. Ambiguous image exercise. Introduction to mind traps and cognitive re-evaluation exercise during the session.Session 6:Module 5: Emotional avoidance and EDBs. Introduction to emotional behaviors. Introduction to EDBs and avoidance types. A cognitive suppression exercise will be carried out during the session. Working with alternative actions.Session 7:Module 6: Physical sensations tolerance. Introduction to interoceptive exposure. Interoceptive exposure exercises during the session: hyperventilating, running on the spot, jumping, breathing through a straw, and twirling.Sessions 8 and 9:Module 7: Emotional exposure. Introduction to the exposure to intense emotions. Building the exposure hierarchy. Introduction to the emotional exposure form.Session 10:Module 8: Maintenance of treatment gains and relapse prevention. Introduction to relapse prevention and plans for future practice. Closure and group farewell among therapists and participants. | PMC10588128 |
Wait-List Control | Participants in the waiting list control will receive the same intervention as described above after the end of the group intervention. Participants on the waiting list will complete the same assessments as the intervention group (T0, T1), except the last one (T2). | PMC10588128 | ||
Criteria for discontinuing or modifying allocated interventions {11b} | In this study, the criteria for discontinuing the intervention will be (1) participants who fail to attend two or more sessions, (2) participants who have current suicidal plans or acts, and (3) participants who request to withdraw from the trial.Participants who have current suicidal plans or acts will be withdrawn from the trial and will receive individual care. | PMC10588128 | ||
Strategies to improve adherence to interventions {11c} | The therapists will encourage the importance of attending scheduled sessions and completing the exercises learned between sessions. After each session, an email will be sent to remind this. If a participant is absent from one session, a member of the research group will contact him/her by phone. | PMC10588128 | ||
Relevant concomitant care permitted or prohibited during the trial {11d} | In this trial, participants who receive another psychological intervention during their participation in the study will be excluded. Psychopharmacological interventions are permitted with the regard that the dose dosage remains stable during the trial. | PMC10588128 | ||
Provisions for post-trial care {30} | No potential harm is expected from this study. | PMC10588128 | ||
Outcomes {12} | PMC10588128 | |||
Primary outcomes | depression, anxiety | In this study, participants are expected to show improvement in anxiety (BAI), and depression (BDI II) at post-treatment (T1) compared to pre-treatment (T0), and this result is expected to remain stable for 3 months (T2). In Wait-List Control, it is expected that there would not be a significant improvement in these variables at T1 compared to T0.The clinical cut-off point for these scales in the Argentine population is 10 points. A cut-off score ≥ 10 in the BDI and BAI indicates clinical anxiety or depression (mild, moderate, or severe). A score ≤ 10 indicates that symptoms of anxiety or depression are not clinically relevant. | PMC10588128 | |
Secondary outcomes | Participants are expected to show improvement in emotion regulation (DERS), quality of life (MQLI), positive and negative affect (PANAS), and hopelessness (BHS) at post-treatment (T1) compared to pre-treatment (T0), and this result is expected to remain stable for 3 months (T2). No significant changes in Wait-List Control on these variables are expected at T1 compared to T0. | PMC10588128 | ||
Participant timeline {13} | The schedule of enrolment, interventions, and assessments are shown in Fig. Schedule of enrolment, interventions, and assessments
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Sample size {14} | DISORDERS | The sample size has been estimated based on a meta-analysis of previous studies of the application of the Unified Protocol in emotional disorders compared to a control group [ | PMC10588128 | |
Recruitment {15} | Participants in this study will be recruited via flyers on social media (Facebook and Instagram), from references from colleagues (university faculty members, clinicians, and researchers), and via flyers/posters on the University of Buenos Aires. | PMC10588128 | ||
Assignment of interventions: allocation | PMC10588128 | |||
Sequence generation {16a} | Simple randomization will be used in this study. Participants who met the inclusion criteria will be randomized to either treatment condition (UP) or Wait-List Control, using specific online software ( | PMC10588128 | ||
Concealment mechanism {16b} | Treatment group assignment to participants or therapists cannot be concealed due to the nature of psychotherapy interventions. The allocation will be made by a member of the research team who will not be involved in the screening or group treatment. | PMC10588128 | ||
Implementation {16c} | RECRUITMENT | A member of the research team who will not be involved in patient recruitment, assessment, or delivering the treatment will perform randomization and allocation. | PMC10588128 | |
Assignment of interventions: blinding | PMC10588128 | |||
Who will be blinded {17a} | Due to the nature of this intervention, treatment allocation cannot be blinded to the therapist or participants. Participants will not receive details about the research aims. | PMC10588128 | ||
Procedure for unblinding if needed {17b} | This trial is not blinded. Unblinding the allocation will not be necessary at any point. | PMC10588128 | ||
Data collection and management | PMC10588128 | |||
Plans for assessment and collection of outcomes {18a} | PMC10588128 | |||
Diagnosis (DSM-5 criteria) | DSM-5 | DISORDERS | A semi-structured online interview will be carried out in order to assess major psychiatric disorders according to the DSM-5 [ | PMC10588128 |
Demographic and satisfaction/acceptability information | PMC10588128 | |||
Ad-hoc socio-demographic questionnaire | An ad-hoc sociodemographic questionnaire was developed in order to assess age, self-perceived gender, place of residence, and educational level. | PMC10588128 | ||
Ad-hoc acceptability and perceived satisfaction with the treatment questionnaire | An ad-hoc questionnaire was developed with the aim of evaluating the experience with the treatment and the acceptability of the intervention. For this purpose, 9 items were constructed with a Likert-type response format from 1 to 10. This questionnaire was based on the previous study of Osma et al. [ | PMC10588128 | ||
Primary outcome measures | PMC10588128 | |||
Secondary outcome measures | depressive, ’ depressive, anxiety | The BDI II is a questionnaire that was designed to measure the severity of individuals’ depressive symptoms. It contains 21 items that explore the typical symptoms of a major depressive episode. Each item presents 4 alternatives, ranging from 0 (not at all) to 3 (severe, almost intolerable), on a Likert-type scale. It was validated and adapted to the Argentine population, with an appropriate internal consistency (Cronbach’s alpha coefficient of 0.88.)It is a scale proposed to measure the severity of anxiety symptoms. It is composed of 21 items and each of these items scores from 0 (not at all) to 4 (I could hardly bear it) on a Likert scale. It has been validated in the Argentine population and shows a good internal consistency (Cronbach alpha coefficient of 0.93). | PMC10588128 | |
Plans to promote participant retention and complete follow-up {18b} | This instrument was created to measure pessimism and hopelessness. It consists of 20 items with a true or false response format, with a possible score that ranges from 0 to 20, with higher scores indicating the presence of strong hopelessness. This instrument was previously validated and adapted to Argentina (Cronbach's alpha coefficient of 0.78).This scale measures the degree to which individuals use different emotional regulation strategies. The adapted scale consists of 30 self-administered items with a five-choice Likert-type scale that ranges from 1 (almost never) to 5 (almost always). This scale presents a robust Cronbach's alpha coefficient of 0.94.This scale was created to measure the quality of life in a brief, multicultural, and multidimensional way. In this self-administered 10-item instrument, each item addresses an area of functioning on a Likert-type scale ranging from 1 (poor) to 10 (excellent). All these items are summarized to obtain a Global Quality of Life Index. This instrument was validated and adapted to the Argentine context with a Cronbach’s alpha coefficient of 0.85.This inventory has been designed to measure affect in a dimensionally way (negative affect and positive affect). It comprises four dimensions: trait positive affect (five items), trait negative affect (five items), state positive affect (five items), and state negative affect (five items). Each item uses a Likert-type scale ranging from 1 (not at all) to 5 (very much or completely). It was validated in Argentina with a good internal consistency (Cronbach’s alpha coefficient of 0.73).Upon completion of the intervention, participants will be contacted by e-mail and phone calls to encourage them to complete the follow-up. | PMC10588128 | ||
Data management {19} | DSM-5 | All data obtained from the screening will be recorded automatically by the secured platform. Patients will accept the informed consent and will be contacted by a researcher of the team for the online interview. The members of the research team in charge of the diagnoses interviews will be trained and will be provided with a semi-structured interview based on DSM-5 in order to unify the criteria. Interview notes will be stored in a secure office at the University of Buenos Aires.After that, patients’ data will be anonymized by a unique ID code on the dataset and will be stored in a secure server and the computer will have a password to be accessed only by the principal investigators. | PMC10588128 | |
Confidentiality {27} | Before entering the study, participants will complete the initial screening and the informed consent. Participants’ information will be encoded with a unique ID number in order to maintain confidentiality. The database will be protected on a computer with password security on a secured platform. Only the principal investigator in the research team will have access to the data. | PMC10588128 | ||
Plans for collection, laboratory evaluation, and storage of biological specimens for genetic or molecular analysis in this trial/future use {33} | N/A, no biological samples will be collected. | PMC10588128 | ||
Statistical methods | PMC10588128 | |||
Statistical methods for primary and secondary outcomes {20a} | SECONDARY | Statistical analysis will be performed with the latest version of SPSS for Windows or R. Sociodemographic variables will be analyzed using descriptive statistics and will be presented in tables. Means and standard deviations will be calculated for numerical variables and frequencies and percentages for categorical variables. The chi-square test and For primary and secondary outcomes, longitudinal changes in each group (T0, T1, T2) and changes between groups will be calculated with a mixed linear model (MANOVA). The effect size for pre and post-treatment and between groups will also be calculated.A Bonferroni-Holm correction will be conducted as a multivariate correction method to address the issue of multiple comparisons. | PMC10588128 | |
Interim analyses {21b} | No interim analysis will be carried out in this trial. | PMC10588128 | ||
Methods for additional analyses (e.g., subgroup analyses) {20b} | In this study, additional analyses have not been planned. | PMC10588128 | ||
Methods in analysis to handle protocol non-adherence and any statistical methods to handle missing data {20c} | To address protocol non-adherence, participant education will emphasize the importance of adhering to the protocol, while clear instructions and materials will be provided. Investigators and research staff will receive training and ongoing support. For this, monitoring and supervision procedures will be implemented to detect and correct deviations. Standardization of intervention and data collection procedures across sites will be ensured. Moreover, motivational strategies will be carried out to encourage adherence while barriers to adherence will be identified and addressed.Missing data will be imputed using the random forest method. | PMC10588128 | ||
Plans to give access to the full protocol, participant-level data, and statistical code {31c} | The corresponding author will provide access to the anonymized data upon reasonable request. | PMC10588128 | ||
Oversight and monitoring | PMC10588128 | |||
Composition of the coordinating center and trial steering committee {5d} | In this trial, members of the research team and the principal researcher will be in charge of and responsible for monitoring the research. | PMC10588128 | ||
Composition of the data monitoring committee, its role and reporting structure {21a} | In this trial, a data monitoring committee (DMC) is not planned due to not expecting any harm to participants. | PMC10588128 | ||
Adverse event reporting and harms {22} | ADVERSE EVENTS | In this study, no harm or adverse events are anticipated (a pilot study has been conducted previously). However, in case of any adverse events, psychotherapists will take appropriate actions to address them. Patients will be encouraged to express any discomfort associated with the intervention and will be provided with information on public places for consultation/treatment. | PMC10588128 | |
Frequency and plans for auditing trial conduct {23} | The School of Psychology of the University of Buenos Aires does not have a department dedicated to auditing current studies. However, the research team meets weekly to monitor the study and its procedures. | PMC10588128 | ||
Plans for communicating important protocol amendments to relevant parties (e.g., trial participants, ethical committees) {25} | All changes in the protocol must be approved by the University of Buenos Aires. If any changes to the protocol are required during this trial, a new protocol will be designed and submitted to the ethics committee for approval before implementation. | PMC10588128 | ||
Dissemination plans {31a} | The results of this study will be disseminated in several ways: (1) in scientific conferences and meetings, (2) in university extension activities, and (3) in peer-reviewed indexed journals in the field of clinical psychology. | PMC10588128 | ||
Discussion | depression, anxiety disorders | DISORDERS | The first aim of the present research is to evaluate the efficacy of the group and online application of the UP in the Argentine population. So far, this is the first randomized controlled trial that assesses the efficacy of a cognitive-behavioral transdiagnostic intervention (in this case, the Unified Protocol) compared to a waiting list condition in a group setting and through teletherapy in our country. These studies are relevant in the Argentine context because cognitive-behavioral interventions are usually developed in high-income countries involving other cultural contexts and little is known about the necessary adaptations for such interventions to be effective in Latin American and middle- or low-income countries.Moreover, being a transdiagnostic and group-based intervention, it allows treating diverse patient populations (anxiety disorders, depression, and related disorders) simultaneously. This saves resources and its implementation in the public health system is particularly relevant in our population given that access to evidence-based therapies is scarce.On the other hand, it is expected that remote treatments via teletherapy will increase the accessibility of treatments. This is important in our population, as access to evidence-based treatments and therapists trained in these treatments is often difficult in rural contexts or places far from large urban centers.Therefore, it is expected that the study of this protocol and its subsequent implementation in health care services will have several advantages. In addition to being a group application (more patients receiving treatment in less time), there are the added benefits of virtuality: people who live far away or who do not have access to nearby care facilities can attend these sessions.Another objective of this trial is to evaluate patients’ experiences of the intervention, which will allow us to decide what adaptations are necessary when applying an intervention of these characteristics in our population. It is hoped that adapting the treatment to patients’ preferences will improve adherence and reduce dropout rates.Finally, this study has some limitations. On the one hand, the fact that participants were recruited via social media can be considered a bias. Having a sample of subjects who interact with our social networks or know someone who does decreases the generalizability of the results. At the same time, although the objective of the inclusion of digital technologies in mental health is to increase access to treatment, participation in the study requires a device with Internet access, which may mean that vulnerable populations without access to digital technologies or the Internet are also excluded from access to these treatments. | PMC10588128 |
Trial status | RECRUITMENT | This is the first version of the protocol v01 (published 11.03.2022). The recruitment process started on April 01, 2022, and is expected to be completed in December 2023.
| PMC10588128 | |
Acknowledgements | Not applicable. | PMC10588128 | ||
Authors’ contributions {31} | CJG is the Chief Investigator. CJG and MJE obtained funding for this study. MC and CFC contributed to the study design. MC drafted the original manuscript. All authors read, provided suggestions, and approved the final manuscript. There are no plans to use professional writers. | PMC10588128 | ||
Funding {4} | This research has received funding from the University of Buenos Aires (UBA, PDE 21/2021). | PMC10588128 | ||
Availability of data and materials {29} | In this study, only members of the research team will have access to the data. | PMC10588128 | ||
Declarations | PMC10588128 | |||
Ethics approval and consent to participate {24} | This research obtained approval from the responsible behaviors committee at the University of Buenos Aires and is registered with the international standard randomized controlled trial number: ID NCT05275322 (ClinicalTrials.gov). Written, informed consent to participate will be obtained from all participants. | PMC10588128 | ||
Consent for publication {32} | Not applicable. | PMC10588128 | ||
Competing interests {28} | The authors declare that they have no competing interests. | PMC10588128 | ||
References | PMC10588128 | |||
Introduction | depression, PCOS, anxiety | SECONDARY, POLYCYSTIC OVARY SYNDROME | Women’s mental health has a significant impact on the health of society. Due to the prevalence of mental health problems in women with PCOS, this study aimed to determine the effect of cognitive behavioral therapy on depression and anxiety (primary outcomes) and quality of life (secondary outcomes) in women with polycystic ovary syndrome. | PMC10174601 |
Methods | Depression, Anxiety, PCOS, Spielberger | POLYCYSTIC OVARY SYNDROME (PCOS) | This randomized controlled trial was performed on 84 patients with PCOS referred to Al-Zahra Hospital in Tabriz-Iran, 2021. Participants were randomly assigned to intervention (n = 42) and control (n = 42) groups. Counseling with cognitive behavioral therapy was provided in 8 sessions of 60–90 min weekly in groups with 5 to 7 people in each group for the intervention group. Spielberger State-Trait Anxiety, Beck Depression, and Quality of Life Questionnaire for women with polycystic ovary syndrome (PCOSQ) were used to collect data. Independent t-test and ANCOVA were used to compare the outcomes between the two groups. | PMC10174601 |
Results | depression, anxiety | After the intervention, based on ANCOVA test with adjusting the baseline values, mean scores of depression (mean difference (MD): -18.6; 95% confidence interval (95% CI): -19.4 to -17.8: P < 0.001), trait anxiety (MD: -15.0; 95% CI: -16.0 to -13.9; P < 0.001), and state anxiety (MD: -15.3; 95% CI: -16.2 to -14.3; P < 0.001), were significantly lower in the intervention group compared to the control group. The mean score of quality of life (MD: 19.25; 95% CI: 17.66 to 20.84; P < 0.001) was significantly higher in the intervention group compared to the control group. | PMC10174601 | |
Conclusion | depression, PCOS, anxiety | This study showed that CBT was effective in reducing depression and anxiety and improving the quality of life. Therefore it is recommended that health care providers use this approach to improve the mental health and quality of life of women with PCOS. | PMC10174601 | |
Trial registration | Iranian Registry of Clinical Trials (IRCT): IRCT20110826007418N7. Date of registration: 25/10/2021. URL: | PMC10174601 | ||
Keywords | PMC10174601 | |||
Background | Anxiety, endocrine disorder, anxiety, palpitations, depression, PCOS, infertility, amenorrhea, worry, Polycystic ovary syndrome, Depression, uneasiness, hyperandrogenism, polycystic ovary, shortness of breath | IRREGULAR MENSTRUATION, ENDOCRINE DISORDER, HIGH BLOOD PRESSURE, SYNDROME, OLIGOMENORRHEA, POLYCYSTIC OVARY SYNDROME, EXCESSIVE HAIR GROWTH | Polycystic ovary syndrome is characterized by hyperandrogenism, polycystic ovary, oligomenorrhea, and amenorrhea. This syndrome is the most common endocrine disorder of women of reproductive age, and various factors are involved in its occurrence [In PCOS, ovaries are enlarged and may contain multiple small cysts, with one or more symptoms of irregular menstruation, excessive hair growth, and infertility [Depression is one of the most important issues studied by psychologists, psychiatrists, and behavioral scientists worldwide [Anxiety is also a common mental condition today. It is an uncomfortable feeling of uneasiness and worry accompanied by physical symptoms such as shortness of breath, palpitations, high blood pressure, etc. [Relaxation, logotherapy, medication, and electroconvulsive therapy are proven to help treat people with anxiety and depression [So far, very little research has been done on the effect of psychological interventions, especially CBT, on depression and anxiety in women with PCOS [ | PMC10174601 |
Methods | PMC10174601 | |||
Study design and participants | anxiety, epilepsy, PCOS, polycystic ovary syndrome, depression, hypertension, diabetes | POLYCYSTIC OVARIES, THYROID DISEASE, EPILEPSY, DYSFUNCTION, POLYCYSTIC OVARY SYNDROME, SECONDARY, IRON DEFICIENCY ANEMIA, HYPERANDROGENISM, HYPERTENSION, DIABETES | This randomized controlled trial with was performed in a parallel design on 84 patients with polycystic ovary syndrome referred to Al-Zahra Hospital in Tabriz-Iran, from July 2021 to October 2021.Inclusion criteria included a minimum of secondary education, diagnosis of polycystic ovary syndrome by a gynecologist (hyperandrogenism, ovulatory dysfunction, and polycystic ovaries), and a medical record of PCOS. Exclusion criteria included having a history of mental illness according to the person’s statement, hypertension, iron deficiency anemia, diabetes, thyroid disease, epilepsy, pregnant and postpartum women.In this study, the sample size was calculated based on both depression and anxiety variables using G-Power software. Based on the results of the study by Mehrabadi et al. (2018) [ | PMC10174601 |
Sampling | Depression, Anxiety, PCOS, infertility | POLYCYSTIC OVARY SYNDROME (PCOS) | The sampling was started after the approval of the Ethics committee of Tabriz University of Medical Sciences (IR.TBZED.REC.1400.229) and registration in Iranian Registry of Clinical Trials (IRCT20110826007418N7). The researcher was referred to the gynecology & infertility clinic of Al-Zahra Hospital and given the list of women with PCOS. She contacted them and briefly explained the goals and method of the research. They were assessed based on the inclusion and exclusion criteria. Eligible and willing women were invited to attend the clinic at a specific time. The goals and methods were fully explained at the meeting then a written consent form was signed by the ones willing to participate in the study. The questionnaires of Spielberger State-Trait Anxiety Inventory (STAI) and Beck Depression Inventory (BDI) were completed. Women who scored 35–65 on STAI and above 20 on BDI were included. Then the questionnaires of socio-demographic characteristics and quality of life for women with polycystic ovary syndrome (PCOSQ) were completed. Women scored 65 or higher on STAI were referred to a psychiatrist. | PMC10174601 |
Randomization | The participants were divided into the intervention and control groups using block randomization, with 4 and 6 block sizes and an allocation ratio of 1:1; within each of these “blocks,” the conditions occurred in a random order. Random sequence generation was conducted by a person not involved in sampling and data collection. Opaque, sealed envelopes were used for allocation concealment. The envelopes were revealed sequentially as the participants entered the study. | PMC10174601 |
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