scholarly journals Induction of Efficacy Expectancies in an Ambulatory Smartphone-based Digital Placebo Mental Health Intervention: Randomized Controlled Trial (Preprint)

10.2196/20329 ◽  
2020 ◽  
Author(s):  
Esther Stalujanis ◽  
Joel Neufeld ◽  
Martina Glaus Stalder ◽  
Angelo Belardi ◽  
Marion Tegethoff ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Controlled Trial ◽  
Health Intervention ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Efficacy Expectancies

scholarly journals A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial

10.2196/30339 ◽  
2021 ◽  
Vol 10 (10) ◽  
pp. e30339
Author(s):  
Pattie P Gonsalves ◽  
Rhea Sharma ◽  
Eleanor Hodgson ◽  
Bhargav Bhat ◽  
Abhijeet Jambhale ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Secondary School ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Sample Size Calculation ◽  
Health Intervention ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background “POD Adventures” is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. Objective Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. Methods We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. Results The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. Conclusions This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. Trial Registration ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 International Registered Report Identifier (IRRID) DERR1-10.2196/30339

scholarly journals A digital mental health intervention to reduce depressive symptoms among overseas Filipino workers: protocol for a pilot hybrid type 1 effectiveness-implementation randomized controlled trial

2020 ◽  
Vol 1 (1) ◽  
Author(s):  
Andrian Liem ◽  
Melissa R. Garabiles ◽  
Karmia A. Pakingan ◽  
Wen Chen ◽  
Agnes Iok Fong Lam ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
Controlled Trial ◽  
Health Intervention ◽  
Anxiety Symptoms ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Hybrid Type

Abstract Background The current pilot randomized controlled trial (RCT) protocol will comprehensively describe the implementation of a culturally adapted Filipino version of the World Health Organization Step-by-Step (SbS-F) program, unguided online psychological intervention for people with depression based on behavioral activation, among overseas Filipino workers (OFWs) in Macao (Special Administrative Region). The main objective of this pilot study is to explore the preliminary effectiveness of the SbS-F program to decrease participant-reported depressive symptoms compared to enhanced care as usual (ECAU); and the secondary objectives are to explore the preliminary effectiveness of the SbS-F to decrease participant-reported anxiety symptoms and improve wellbeing, and to evaluate the potential for SbS-F implementation in real-world settings. Methods This trial will follow an effectiveness-implementation hybrid type 1 trial design and utilize the Reach, Efficacy/Effectiveness, Adoption, Implementation, and Maintenance (RE-AIM) framework to accelerate the translation of clinical research into more effective implementation strategies and policies. Participants will be randomized 1:1 to control and treatment groups. Control group participants will receive ECAU that consists of brief depression psychoeducation and referral to local community partners. Treatment group participants will receive a 5-session of digital intervention through a mobile phone application. The primary outcome (depression) and psychological secondary outcomes (anxiety symptoms and wellbeing) will be measured using validated instruments. To evaluate study implementation, an embedded mixed-methods design will be used to collect data from various stakeholders. Data then will be analyzed using intention to treat principle and reported following the Consolidated Standards of Reporting Trials (CONSORT) guideline. Discussion This study will provide important new knowledge about the preliminary effectiveness of SbS-F, a mobile application, as a digital mental health intervention and its scalability. If SbS-F shows positive results among OFWs in Macao, it has strong potential to be used by OFWs in other countries that may also experience depression and difficulty accessing mental health services. Trial registration Prospective registration, Chinese Clinical Trial Registry (ChiCTR2000034959) on 26/07/2020.

scholarly journals A Guided Internet-Based Problem-Solving Intervention Delivered Through Smartphones for Secondary School Pupils During the COVID-19 Pandemic in India: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2021 ◽  
Author(s):  
Pattie P Gonsalves ◽  
Rhea Sharma ◽  
Eleanor Hodgson ◽  
Bhargav Bhat ◽  
Abhijeet Jambhale ◽  
...  
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Secondary School ◽  
Controlled Trial ◽  
Pilot Trial ◽  
Sample Size Calculation ◽  
Health Intervention ◽  
Mental Health Intervention ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND “POD Adventures” is a gamified mental health intervention delivered via a smartphone app and supported by counsellors for a target population of secondary school students in India. This paper describes the protocol for a pilot randomized controlled trial of a remotely delivered version of the intervention in the context of COVID-19 restrictions. OBJECTIVE Our objectives are to assess the feasibility of research procedures and intervention delivery and to generate preliminary estimates of the effectiveness of the intervention to inform the sample size calculation of a full-scale trial. METHODS We will conduct a parallel, 2-arm, individually randomized pilot controlled trial in 11 secondary schools in Goa, India. This pilot trial aims to recruit 70 participants with a felt need for psychological support. Participants will receive either the POD Adventures intervention delivered over 4 weeks or usual care comprising information about local mental health services and national helplines. Outcomes will be assessed at two timepoints: baseline and 6 weeks post randomization. RESULTS The first participant was enrolled on January 28, 2021, and 6-week assessment completed on April 4, 2021. Owing to a second wave of the COVID-19 pandemic in India, schools in Goa were closed on April 22, 2021. Trial participants are currently receiving the intervention or completing follow-up assessments. CONCLUSIONS This pilot trial will help understand the feasibility of implementing and evaluating a remotely delivered digital mental health intervention in a low-resource setting. Our findings will be used to design future trials that can address difficulties of accessing psychosocial support in-person and support wider efforts to scale up evidence-based mental health interventions for young people. CLINICALTRIAL ClinicalTrials.gov NCT04672486; https://clinicaltrials.gov/ct2/show/NCT04672486 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/30339

scholarly journals Manipulating efficacy expectancies in an ambulatory smartphone-based digital placebo mental health intervention: a randomized controlled trial (Preprint)

2020 ◽  
Author(s):  
Esther Stalujanis ◽  
Joel Neufeld ◽  
Martina Glaus Stalder ◽  
Angelo Belardi ◽  
Gunther Meinlschmidt
Keyword(s):  
Mental Health ◽  
Controlled Trial ◽  
Health Intervention ◽  
Health Interventions ◽  
Mental Health Intervention ◽  
Placebo Effects ◽  
Intention To Treat ◽  
Randomized Controlled ◽  
Mental Health Interventions ◽  
Efficacy Expectancies

BACKGROUND Smartphone-based mental health interventions provide new ways to treat mental disorders. There is certain evidence on the efficacy of such interventions. Placebo effects represent a substantial element of the mechanisms of action of face-to-face mental health interventions. OBJECTIVE We manipulated efficacy expectancies and investigated whether time trajectories of efficacy expectancies differed between conditions across a smartphone-based digital placebo mental health intervention. METHODS We conducted a randomized, controlled, single-blinded superiority trial with a multi-arm parallel design. Participants underwent a smartphone-based digital placebo mental health intervention for 20 consecutive days. We induced prospective efficacy expectancies by manipulating initial instructions on the purpose of the intervention and retrospective efficacy expectancies by manipulating feedback on the success of the intervention at days 1, 4, 7, 10, and 13. 132 healthy participants were randomized to four conditions: prospective expectancy only (n=33), retrospective expectancy only (n=33), combined expectancy (n=34), or control (n=32). Changes in efficacy expectancies were assessed with the Credibility Expectancy Questionnaire, at the introductory session and on intervention days 1, 7, 14, and 20. We performed our analyses for the intention-to-treat sample using a random effects model, with intervention day as time variable and condition as two factors: prospective expectancy (yes vs. no), and retrospective expectancy (yes vs.no), allowed to vary over participant and intervention day. RESULTS Credibility (b = -1.63, 95%confidence interval (CI) [-2.37, -0.89], P < 0.001) and expectancy (b = -0.77, 95%CI [-1.49, -0.05], P = 0.04) decreased across intervention days. For credibility and expectancy, we found significant three-way interactions intervention day*prospective expectancy*retrospective expectancy (b = 2.05, 95%CI [0.60, 3.50], P < 0.01 resp. b = 1.55, 95%CI [0.14, 2.95] P = 0.03). Efficacy expectancies decreased least in the combined expectancy and in the control condition, most in the prospective expectancy only and the retrospective expectancy only condition. CONCLUSIONS This is the first study investigating the induction of efficacy expectancies across a placebo smartphone-based mental health intervention. Efficacy expectancies decreased throughout intervention days and differed between conditions. Our findings may pave the way for diminishing and exploiting digital placebo effects and help to improve treatment efficacy of digital mental health interventions. CLINICALTRIAL ClinicalTrials.gov Identifier: NCT02365220. Registered February 18, 2015.

scholarly journals Effect of Paula exercise method on functional outcomes of women with post fistula repair incontinence: a protocol for randomized controlled trial

2021 ◽  
Vol 21 (1) ◽  
Author(s):  
Saratu Umar Aliyu ◽  
Shmaila M. Hanif ◽  
Isa Usman Lawal
Keyword(s):  
Quality Of Life ◽  
Mental Health ◽  
Randomized Controlled Trial ◽  
Pelvic Floor ◽  
Controlled Trial ◽  
Fistula Repair ◽  
Randomized Controlled ◽  
Urine Leakage ◽  
Pelvic Floor Strength

Abstract Background Post-fistula-repair incontinence (PFRI) is a common complication of vesicovaginal fistula (VVF) surgeries. It entails continuous leakage of urine after successful VVF closure. Pelvic Floor Muscle Training (PFMT) plays a vital role in the management of PFRI, however, an evolving exercise approach is the Paula Exercise Method (PEM) which has shown a promising effect in stopping urinary incontinence, but there is no data on its effect on PFRI. This study therefore, proposes to primarily investigate the effect of PEM on urine leakage and secondarily, pelvic floor strength (PFS), quality of life (QoL), sexual function (SF), and mental health (MH) in women with PFRI. Methods This is a study protocol for a randomized controlled trial. A total of 182 participants are expected to participate in the study after satisfying the inclusion criteria. The participants will be randomized into either PEM or PFMT study groups. The demographic data of all the participants will be recorded. Each participant will be assessed for urine leakage, PFS, QoL, SF, and MH at baseline and subsequently, at four, eight and 12 weeks of intervention. Demographic parameters will be summarized using descriptive statistics. Continuous data will be computed for differences using inferential statistic of Analysis of variance, t-test and Man Whitney U as appropriate. All analyses will be performed using SPSS version 22.0 with probability set at 0.05 alpha level. Discussion It is hoped that the outcome of this study will determine the effect of the Paula exercise method on urine leakage, pelvic floor strength, quality of life, sexual function, and mental health among women with post-fistula-repair incontinence and also provide evidence for the use of the Paula method in urinary incontinence. Trial registration: Pan African Clinical Trials Registry (www.pactr.org), identifier PACTR201906515532827.

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