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Ethics approval and consent to participate | This research was reviewed and approved by the Kaiser Foundation Research Institute Institutional Review Board (IRB) FW00002344 of Kaiser Permanente Washington. All methods were carried out in accordance with relevant guidelines and regulations as assessed by the IRB. IRB-approved procedures were used to obtain informe... | PMC9874175 | ||
Consent for publication | Not applicable. | PMC9874175 | ||
Competing interests | The authors have no conflicts of interest relevant to this article to disclose. The authors have no financial relationships relevant to this article to disclose. | PMC9874175 | ||
References | PMC9874175 | |||
Subject terms | TRD, treatment-resistant depression, ideation | ADVERSE EVENTS, REMISSION, DRUG WITHDRAWAL | Psilocybin is being investigated as a treatment in adults with treatment-resistant depression (TRD). Withdrawal from serotonergic antidepressant drugs is a common prerequisite for taking part in trials of psilocybin due to the possibility of ongoing antidepressant drugs altering the psychedelic effect. This phase II, e... | PMC10425429 |
Introduction | TRD, treatment-resistant depression, depressive disorder, treatment-resistant, MDD, cancer-related depression | Psilocybin has demonstrated antidepressant properties in preclinical models and small trials of participants with cancer-related depression, major depressive disorder (MDD), and treatment-resistant depression (TRD) [Reports from surveys suggest that the acute subjective psychedelic effects of psilocybin, and of another... | PMC10425429 | |
Materials and methods | PMC10425429 | |||
Trial oversight | treatment-resistant MDD | This was a phase II, exploratory, fixed-dose, open-label study conducted between August 2020 and September 2021. This trial explored the safety and efficacy of a single dose of 25 mg of the investigational drug COMP360, a proprietary pharmaceutical-grade synthetic psilocybin formulation, optimized for stability and pur... | PMC10425429 | |
Participants | TRD, psychiatric | DISORDER, DISORDERS | This study recruited adults aged 18 years or older who were outpatients and referred by practitioners from specialized psychiatric services or word of mouth from primary care services. Participants were experiencing TRD, defined by meeting the Diagnostic and Statistical Manual of Mental Disorders (5Participants were ta... | PMC10425429 |
Study design and procedures | C-SSRS | BLOOD | Eligible participants entered the screening period and attended the clinic weekly for three weeks prior to the psilocybin administration session. During this time, eligibility and safety assessments took place including monitoring of medication changes, suicidality (C-SSRS), electrocardiograms (ECGs), blood tests, and ... | PMC10425429 |
Safety end points | ideation | ADVERSE EVENTS, EVENTS | Safety outcomes included ECG, clinical laboratory tests, vital signs, incidence of adverse events, and change from Baseline in suicidal ideation and behavior measured by the C-SSRS.Adverse events were examined at every visit and followed until resolved or stable. Treatment-emergent adverse events (TEAEs) were coded usi... | PMC10425429 |
Efficacy end points | Depression, ill | SECONDARY, REMISSION | The primary efficacy end point was the change in Montgomery-Åsberg Depression Rating Scale (MADRS) total score from Baseline (Day -1) to three weeks post-psilocybin administration (Week 3) [Key secondary end points included the proportion of participants with a response (defined as a ≥50% improvement in MADRS total sco... | PMC10425429 |
Exploratory end points | depression, Depressive, Anxiety, anxiety | DISORDER | Exploratory end points included change in total score from Baseline to Week 3 in participant EQ-5D-3 level (EQ-5D-3L) which captures an index of health state based on response to five dimensions of quality of life on a three-point scale ranging from “no problems” to “extreme problems” and additionally includes the EQ-V... | PMC10425429 |
Statistical analysis | suicidality | SECONDARY | No formal sample size calculations were performed for this study. There was no imputation for missing efficacy data and the observed data were used in statistical analyses.Safety analyses were performed on the safety analysis set which included all participants who received psilocybin. Descriptive statistics were used ... | PMC10425429 |
Results | PMC10425429 | |||
Primary and secondary efficacy results | The mean MADRS total score at Week 3 was 16.8 (95% confidence interval [CI], 11.2–22.4) which equated to a clinically meaningful mean change from Baseline of −14.9 (95% CI, −20.7 to −9.2). This improvement was apparent at Day 2 and maintained throughout the three-week follow-up (Fig. | PMC10425429 | ||
Change from baseline in MADRS total score (full analysis set). | depression | CI confidence interval, MADRS Montgomery-Åsberg depression rating scale, SD standard deviation, SSRI selective serotonin reuptake inhibitor. Note: Baseline mean (SD): COMP360 25 mg + SSRI = 31.7 (5.77).Response (≥50% reduction from Baseline MADRS total score) at Week 3 was evident in eight (42.1%) participants and was ... | PMC10425429 | |
Change from baseline in CGI-S score and proportion of CGI-S responders over time (full analysis set). | CGI-S Clinical Global Impressions – Severity, CI confidence interval, SSRI selective serotonin reuptake inhibitor. Number of CGI-S responders stated in bars. Note: Mean change from Baseline CGI-S score was −1.3 at Week 3.The results from per-protocol analysis of the primary end point were consistent with the full analy... | PMC10425429 | ||
Exploratory results | auditory alterations, depression, anxiety | Improvements in quality of life, wellbeing, anxiety, affect, and self- and clinician-reported depression were evident at all time points following psilocybin administration.Participants’ EQ-5D-3L mean total score at Baseline was 0.51 (SD = 0.333) and improved by an average of 0.18 (SD = 0.310) by Week 3. The EQ-VAS mea... | PMC10425429 | |
Discussion | TRD, depression, TEAE, anxiety | DRUG WITHDRAWAL | In participants with TRD, a single administration of psilocybin 25 mg with psychological support adjunctive to an SSRI demonstrated a generally favorable safety profile and therapeutic efficacy across a range of clinician and self-rated measures. Contrary to speculation in prior literature [Most TEAEs were mild, short-... | PMC10425429 |
Supplementary information | The online version contains supplementary material available at 10.1038/s41386-023-01648-7. | PMC10425429 | ||
Acknowledgements | BREDA | We sincerely thank the participants, without whom this research would not have been possible. We thank the following members of staff at COMPASS Pathfinder Ltd and Worldwide Clinical Trials for their contributions: Molly Lennard-Jones, Rachel Winzer, Batya Septimus, Merve Atli, Ozlem Redjep, Hannah Tadley, Nisha Thiara... | PMC10425429 | |
Author contributions | D.F. | ADVERSE EVENTS | Conception or design of the work (G.G., E.M., L.M., C.S., S.C.S., S.W.); finalization of analysis plans (S.M., H.S., J.T.); the acquisition of the data (D.F., J.R.K., V.OK., S.KP., S.C.S., S.W.); the analysis of the data (S.M., H.S.); the interpretation of data (M.C., G.G., C.S., L.M., S.M., H.S., J.T.). All authors dr... | PMC10425429 |
Funding | This study was funded and sponsored by COMPASS Pathfinder Ltd, London, UK. | PMC10425429 | ||
Competing interests | neuropsychiatric disorders | CEREBRAL PALSY | A contract research organization (Worldwide Clinical Trials), paid by the sponsor, supervised the conduct of the trial under the direction of the sponsor. An independent contract research organization (Worldwide Clinical Trials) were responsible for conducting MADRS assessments with blinded remote raters. The analysis ... | PMC10425429 |
References | PMC10425429 | |||
Materials and methods | Using a single-blinded parallel group randomized controlled trial design, 68 volunteers were assigned to either a study group (SG) or a control group (CG). The SG received information about oral health during pregnancy via Snapchat, while the CG received the same information using WhatsApp. The participants were assess... | PMC9934359 | ||
Results | A total of 63 participants completed the study in the SG or CG. According to paired t-test, total knowledge scores in the SG and CG increased significantly from T1 to T2 ( | PMC9934359 | ||
Conclusions | Using social media (e.g., Snapchat and WhatsApp) as a health-promoting intervention is a promising method for improving women’s knowledge about oral health during pregnancy for short term. However, further studies are needed to compare social media with conventional standard lecturing methods. also, to assess the longe... | PMC9934359 | ||
Data Availability | All relevant data are within the paper and its | PMC9934359 | ||
Introduction | tooth mobility, xerostomia, granuloma, caries | XEROSTOMIA, PREGNANCY GINGIVITIS, GRANULOMA, CARIES | Social media is defined as any of a collection of applications that use the internet to create technical and ideological foundations that permit generating and sharing of content [Pregnancy is a unique health phase in a woman’s life, as it is influenced by complicated physiological changes that can have a negative impa... | PMC9934359 |
Aim | The aim of this study was to evaluate the effects of social media (specifically Snapchat) health-promoting interventions on oral health knowledge during pregnancy among pregnant women. | PMC9934359 | ||
Materials and methods | PMC9934359 | |||
Study design and participants | This study used a single-blinded parallel group RCT design in which study group (SG) participants received information about oral health during pregnancy via the Snapchat mobile application. Only participants were blinded, while examiners and statistician were not. The participants in the control group (CG) received th... | PMC9934359 | ||
Participant interaction flowchart. | CONSORT guidelines were used to document this study. The participants were all pregnant women living in Saudi Arabia (at any city), and they were recruited using convenience sampling through invitations to social media groups about pregnancy in Saudi Arabia. This includes WhatsApp, Twitter, and other social media platf... | PMC9934359 | ||
Setting | blindness | BLINDNESS | After an initial agreement to participate in the study, an invitation was sent as a message to potential participants’ mobile phones using the WhatsApp platform, which allowed for communication between the participants and the research team and sending or receipt of the consent, intervention/CG flyer, and the online qu... | PMC9934359 |
Intervention and control | The trail started at 03/11/2021. Participants in the SG received information regarding oral health during pregnancy using the Snapchat mobile application. The oral health information was retrieved from previous studies [The stories were presented as a diary of the research team members, like most of the stories on Snap... | PMC9934359 | ||
Assessment | Questionnaires in a self-reported soft copy format were distributed to both groups at the three time points previously discussed: T1, T2, and T3. All identifiable data used to match participant data in T1, T2, and T3 were discarded after completing the T3 data collection. The questionnaires were identical for both grou... | PMC9934359 | ||
Contents of questionnaire at T1, T2, and T3. | The first part of the questionnaire included questions to collect demographic information on age, marital status, education level, family monthly income, regular visits to a dentist, number of children, month of current pregnancy, and sources of dental information. The second part included questions about the use of so... | PMC9934359 | ||
Incentives and ethical considerations | MINOR, -11 | After data collection at T3, all identifiable data were completely discarded. Participation was voluntary, and as an incentive, the participants were entered into six separate random prize drawings for 50 Saudi Riyals (USD 13.33) in the form of local bookstore gift cards. Before participating in the intervention, all p... | PMC9934359 | |
Data analysis | The statistically significant level was set at 0.05. The data were gathered, tabulated, and statistically analyzed using SPSS software package version 27 (IBM Corp., Armonk, NY, USA). Chi-square, t-test, Fisher’s exact test, and paired t-test were used to analyze the data collected in this study. The family monthly inc... | PMC9934359 | ||
Results | A total of 90 participants were invited to this study, but only 68 agreed to participate (response rate = 75.55%). The randomization process yielded 34 participants in the SG and a similar number in the CG. A total of 5 participants dropped out of the study, resulting in 30 participants in the SG and 33 participants ... | PMC9934359 | ||
Demographic variables of the pregnant women in this study. | PMC9934359 | |||
Frequency of using social media by pregnant women in Saudi Arabia in the current study. | " | PMC9934359 | ||
Mean knowledge scores of the pregnant women in the study and control groups at T1, T2, and T3. | Using independent t-test, no significant differences were found between the SG and CG at T2 (t(61) = −1.148, The total knowledge score in the SG increased significantly from T1 to T2 with t(29) = −6.304, " | PMC9934359 | ||
Changes in total knowledge scores over time. | PMC9934359 | |||
Differences in total knowledge scores of the pregnant women at T1, T2, and T3. | " | PMC9934359 | ||
Study participants’ responses to receiving information in Snapchat (study group) or WhatsApp (control group). | PMC9934359 | |||
Discussion | The aim of this study was to evaluate social media (Snapchat) health-promoting interventions on knowledge about oral health during pregnancy among pregnant women in Saudi Arabia. The findings revealed that participants in both the study and control groups had significant improvements in their knowledge immediately afte... | PMC9934359 | ||
Conclusion | Social media (Snapchat and WhatsApp) seem to be promising tools for promotional interventions to improve public health and dental knowledge among pregnant women, as well as with other health care topics. However, Snapchat is not superior to WhatsApp in terms of effectiveness. Snapchat is easy and popularly used among p... | PMC9934359 | ||
Supporting information | PMC9934359 | |||
Study protocol in details. | (PDF)Click here for additional data file. | PMC9934359 | ||
Study raw data. | (PDF)Click here for additional data file. | PMC9934359 | ||
List of abbreviations | Control groupRandomized controlled trialStandard deviationStudy group | PMC9934359 | ||
References | PMC9934359 | |||
Abstract | PMC10315809 | |||
Background | breast cancer | BREAST CANCER DIAGNOSIS, BREAST CANCER | Breast cancer diagnosis and treatment increase the potential psychological impact on breast cancer survivors (BCS). The objective of this study was to assess the effects of an interdisciplinary intervention during follow‐up in BCS and identify variables related to improvements in HRQoL. | PMC10315809 |
Materials and Methods | depression, generalised, anxiety | In a non‐randomised quasi‐experimental design performed on an outpatient basis in a hospital gynaecology and oncology unit, 60 BCS were assigned to an interdisciplinary experimental group (EG) or a usual care group (CG). The EG underwent 12 sessions of an interdisciplinary program which included Mindfulness and physiot... | PMC10315809 | |
Results | depression, anxiety, fatigue, pain | After 6 weeks, statistically significant differences were apparent in global and cancer‐related health symptoms such as fatigue and pain in the EORTC QLQ‐C30 and in anxiety and depression, among the EG ( | PMC10315809 | |
Conclusions | depression, 6‐week, anxiety | The results of our study suggest that a 6‐week interdisciplinary intervention may improve HRQoL and symptomatology of anxiety and depression in BCS patients at 3 months. The study presents data that the intervention for BCS appears promising and warrants further study in a randomised controlled trial.
| PMC10315809 | |
INTRODUCTION | cancers, breast cancer, cancer, tumour, Cancer | CANCERS, RECURRENCE, BREAST CANCER, CANCER, DISEASE, TUMOUR, CANCER | Although breast cancer (BC) remains a highly prevalent form of cancer in women around the world, advances in early diagnosis and treatment have resulted in increased survival. In Spain, it remains the most frequent tumour among women and is one of the cancers with the highest rate of incidence, mortality and recurrence... | PMC10315809 |
MATERIALS AND METHODS | PMC10315809 | |||
Subjects | psychiatric | ORGANIC DISORDER | The study population was drawn prospectively from patients who had been referred to the gynaecology and oncology unit of Galdakao‐Usansolo Hospital. Women aged over 18 who had been diagnosed and treated for BC 2 years earlier were included. Patients who declined to participate in the study or were suffering from a seve... | PMC10315809 |
Study design and intervention | BREAST CANCER | We used a non‐randomised quasi‐experimental design.A total of 87 BCS were invited to participate in the study. Of these, 60 women who had survived BC voluntarily agreed to take part in the study (Figure Flowchart of the sample of patients with breast cancer. CG, Control Group; EG, Experimental Group. | PMC10315809 | |
The interdisciplinary group intervention | The In the | PMC10315809 | ||
Instruments and data collection | PMC10315809 | |||
Clinical data | PATHOLOGY |
Related to patients' personal background.Related to the care process.Related to neoadjuvant treatment.Related to anatomical pathology.Related to follow‐up at 2 years and adjuvant treatment. | PMC10315809 | |
Patient‐reported measures |
The self‐report version of the
To determine the patients' opinions of the intervention they had received, an ad‐hoc | PMC10315809 | ||
Statistical analysis | generalised, depression | Descriptive statistics included frequencies and percentages for categorical data and means and standard deviations for continuous variables. Differences between experimental and control groups were evaluated using the Chi‐square or Fisher exact test for categorical variables and Student In all the questionnaires, the d... | PMC10315809 | |
RESULTS | BREAST CANCER | The study sample comprised 87 patients with BC. Of these, 60 patients agreed to participate; all completed the instruments at baseline and 6 weeks and 3 months following the intervention (Figure Table Baseline data on patients with breast cancer, by group (experimental or control).Abbreviations: Data are given as media... | PMC10315809 | |
DISCUSSION | anxiety, fatigue, cancer, 6‐week, pain, depression | CANCER, DISEASE, RECURRENCE | To summarise, BC and its treatment pose many challenges to the patient's physical, emotional, mental and social well‐being and negatively impact the patient's QoL. Furthermore, HRQoL and its domains are important measures for cancer survivorship as they provide prognosticAn interdisciplinary treatment that included coo... | PMC10315809 |
AUTHOR CONTRIBUTIONS | PMC10315809 | |||
FUNDING INFORMATION | Cancer | CANCER | This study was partly financed by funds awarded by the Asociación Española Contra el Cáncer (Spanish Association Against Cancer, Junta de Bizkaia) (AECC14/901) and the Carlos III Health Institute (PI12/01842) to principal investigator Susana García, and the University of the Basque Country UPV/EHU. | PMC10315809 |
CONFLICT OF INTEREST STATEMENT | The authors declare that they have no competing interests. | PMC10315809 | ||
ETHICAL APPROVAL STATEMENT | All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and/or national research committee and with the 1964 Helsinki declaration, subsequent amendments thereto and comparable ethical standards. | PMC10315809 | ||
CLINICAL TRIAL REGISTRATION NUMBER | NCT02439554. | PMC10315809 | ||
Supporting information |
Figure S1
Click here for additional data file.
Table S1
Click here for additional data file.
Table S2
Click here for additional data file.
Table S3
Click here for additional data file. | PMC10315809 | ||
ACKNOWLEDGMENTS | breast cancer | BREAST CANCER | The authors wish to thank the Research Committee of Galdakao‐ Usansolo Hospital for its help in editing this article. We also acknowledge the editorial assistance provided by Tim Nicholson. We are particularly grateful to the women with breast cancer who collaborated in our research. | PMC10315809 |
DATA AVAILABILITY STATEMENT | The data that support the findings of this study are available from the corresponding author at email direction ( | PMC10315809 | ||
REFERENCES | PMC10315809 | |||
Abstract | PMC10098273 | |||
Objectives | This study aims to evaluate the effectiveness of two different distraction techniques (Audio Video Distraction/Video Game Distraction) in the management of anxious pediatric patients during dental treatment. | PMC10098273 | ||
Materials and Methods | pain | GROUP B | One hundred and five children were randomly divided into three groups; Group A: active distraction using video games on a tablet device and wireless joystick (VG). Group B: passive distraction using video on tablet, and wireless headphones (AV). Group C (Control group): basic behavior guidance technique Tell Show Do wa... | PMC10098273 |
Results | pain | One hundred and five children completed the study (57 boys and 48 girls) aged between 6 and 10 years (mean age of 7.4 years). The active distraction (VG) group was superior to the passive distraction (AV) group and the control group (C) on the pain scale with statistically significant differences as appeared in Simplif... | PMC10098273 | |
Conclusion | anxiety, pain | POSITIVE | Positive distraction with video games by wireless joystick displayed on the portable tablet on the dental chair was the best technique for reducing dental anxiety and reported pain in school children (6‐10 years) and was better than negative distraction by video cartoons on the tablet device.
This clinical trial was ap... | PMC10098273 |
INTRODUCTION | behavioral disturbance, hearing and vision, anxiety, pain | The foundation of pediatric dental practice is the ability to establish a good dental experience (Avery's et al., For many years the process of leading a child in the dental clinic was called “behavior management” but in 2005 the term “Behavior Guidance” was adopted in the recommendations of the American Academy of Ped... | PMC10098273 | |
MATERIALS AND METHODS | PMC10098273 | |||
Study design | This study was designed as a randomized controlled trial (RCT) to compare the effectiveness of (VG) distraction and (AV) distraction to a control group during pulpotomy in primary mandibular molars in 6–10‐year‐old children.This clinical trial was conducted in the Department of Pediatric Dentistry at Damascus Universit... | PMC10098273 | ||
Sample size calculation | The sample size was calculated using G‐Power 3.1 statistical program with ( | PMC10098273 | ||
Patient selection | DISORDERS | Children were selected from the Department of Pediatric Dentistry, Damascus University, Faculty of Dentistry, based on the following inclusion criteria:
Children required pulpotomy in a primary mandibular molar.Aged between 6 and 10 years.Children were categorized definitely positive or positive ratings on the Frankl s... | PMC10098273 | |
Randomized allocation | The children were randomly assigned according to the website | PMC10098273 | ||
Intervention | AIDS, GROUP B | The pulpotomy technique was performed for all children following the standard protocol and the groups were divided according to the method of distraction (Figure Group A: (VG) active distraction with using video games on a tablet device, wireless joystick, and wireless headphones.Group B: (AV) passive distraction with ... | PMC10098273 | |
Pain assessment scale | pain | The Simplified Wong‐Baker FACES pain rating scale was used in this study due to the reliability that was proved by Haji‐Bakr‐and AL‐monakel (Haji. Baker Rasha, After completing the dental treatment and removing the rubber dam, the children were immediately asked to fill a face of the scale that described how they felt ... | PMC10098273 | |
Behavior assessment scale | pain | The Behavior Rating Scale “HOUPT” for Overall Behavior. The external observer was selected 1 of the 6 scales at the end of treatment. Scales are shown in (Figure Different techniques used in the study: (a) active distraction, (b) passive distraction, and (c) Tell‐Show‐Do.Consort flow diagram.Simplified Wong–Baker FACES... | PMC10098273 | |
Statistical analysis | The statistical analysis was carried out using SPSS 24.0. One‐way ANOVA was used to study the differences between the three groups according to behavioral scale scores (HOUPT score, Simplified Wong‐Baker faces scale). | PMC10098273 | ||
RESULTS | T‐test, pain | GROUP B | A total of 105 children, (57 boys and 48 girls, mean age 7.4) completed the study. In all groups, pain and behavioral scale scores (Simplified W‐B Faces, HOUPT) were recorded. One‐way ANOVA statistical test was done, and a significant difference was noticed between three groups on the overall behavior scale One‐way ANO... | PMC10098273 |
DISCUSSION | vomiting reflex, Inferior Alveolar Nerve Block, anxiety, pain | POSITIVE | Dental fear and anxiety have an impact on the quality of dental treatment (Milgrom et al., Therefore, many procedural, behavioral, and nonpharmacological techniques have been proposed to reduce pain and discomfort during pediatric dental treatment. This study was conducted to compare different distraction techniques (a... | PMC10098273 |
CONCLUSION | anxiety, pain | Within the limits of this study, it can be concluded that the use of video games via joystick on tablets and headphones gave the best result in relieving dental anxiety and pain during pulpotomy in children.Although the use of cartoon films through the tablet and headphones did not reduce the described pain in children... | PMC10098273 | |
DETERMINANTS | BLIND | A limitation of this study was the inability to blind the external investigator from the use of joystick and headphones, and the unacceptability of some children to use joystick and headphones. | PMC10098273 | |
AUTHOR CONTRIBUTIONS | Ekram AlSibai conceived the idea and provided the treatment. Ekram AlSibai contributed to the writing. Hasan Alzoubi to the documenting. Nada Bshara conceived the idea and supervised the treatment. Laith Al Sabek contributed to study design. | PMC10098273 |
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