A protocol for a pilot randomized controlled trial of guided self-help Behavioral Activation intervention for geriatric depression

AbstractBackgroundAging is a social concern. Despite increased incidence of depression in Chinese older populations, they are often misdiagnosed and undertreated, which pose a challenge to our health care system. Depressed older adults often suffer from lack of motivation. Evidence-based guided self-help behavioral activation treatment is effective in reducing anhedonia and amotivation symptoms, however the efficacy in in elderly depressed patients are unknown yet. So the current study aim to pilot the self-help guided intervention for the treatment of depression in elderly patients.Methods/designA pilot randomized controlled trial with 30 elderly inpatients with major depressive disorder will be conducted. Participants attending clinical psychological clinics at Mental Health Center of Chongqing will be randomized to receive guided self-help BA intervention or to a 6-week waiting list control. Participants in the treatment group will receive 6 sessions of guided self-help BA intervention delivered over the telephone. The waiting list control group will receive the intervention after a waiting period of 6 weeks. Exclusion criteria are limited to those at significant risk of harm to self or others, the presence of primary mental health disorder other than depression or intellectual disability at a level meaning potential participants would be unable to access the intervention. The study has ethical approval from the Chinese Research Ethics Committee. Our hypothesis is that guided self-help BA will effective when compared with the waiting-list intervention.ResultsEffects of the treatment were observed on three outcomes domains: (1) clinical outcomes (symptom severity, recovery rates); (2) process variables (patient satisfaction, attendance, dropout); and (3) economic outcomes (cost and resource use). We also examine mediators of outcomes in terms of patient variables (behavioral activation/inhibition motivation). Results will be disseminated to patients, the wider public, clinicians and researchers through publication in journals and presentation at conferences.DiscussionThis is the first study to investigate guided self-help interventions for China geriatric depressed patients, a group which is currently under-represented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression (BATD). The generalizability and broad inclusion criteria are strengths but may also lead to some weaknesses.

Download Full-text

Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial

JMIR Research Protocols ◽

10.2196/18259 ◽

2020 ◽

Vol 9 (9) ◽

pp. e18259

Author(s):

Xiaoxia Wang ◽

Xiaoyan Zhou ◽

Hui Yang

Keyword(s):

Mental Health ◽

Older Adults ◽

Randomized Controlled Trial ◽

Health Center ◽

Behavioral Activation ◽

Mental Health Center ◽

Controlled Trial ◽

Randomized Controlled ◽

Self Help ◽

Pilot Randomized Controlled Trial

Background Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known. Objective The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults. Methods This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect. Results The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences. Conclusions This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths. Trial Registration Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548 International Registered Report Identifier (IRRID) PRR1-10.2196/18259

Download Full-text

Guided Self-Help Behavioral Activation Intervention for Geriatric Depression: Protocol for Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.18259 ◽

2020 ◽

Author(s):

Xiaoxia Wang ◽

Xiaoyan Zhou ◽

Hui Yang

Keyword(s):

Mental Health ◽

Older Adults ◽

Randomized Controlled Trial ◽

Health Center ◽

Behavioral Activation ◽

Mental Health Center ◽

Controlled Trial ◽

Randomized Controlled ◽

Self Help ◽

Pilot Randomized Controlled Trial

BACKGROUND Aging is a social concern. The increased incidence of depression in older populations in China poses a challenge to the health care system. Older adults who are depressed often suffer from a lack of motivation. Behavioral activation treatment, an evidence-based guided self-help treatment, is effective in reducing anhedonia and amotivation in depression; however, the efficacy of guided self-help behavioral activation in older adults with depression is not yet known. OBJECTIVE The aim of this study is to pilot a self-help guided intervention for the treatment of depression in older adults. METHODS This study has been designed as a pilot randomized controlled trial with inpatients (n=60; to be randomly allocated 1:1) between the ages of 60 and 70 and who have major depressive disorder. Patients attending clinical psychological clinics at the Mental Health Center of Chongqing will be randomized to either receive guided self-help behavioral activation (intervention) or to be on a 6-week waiting list (control). Participants in the treatment group will receive 6 sessions of guided self-help behavioral activation delivered over the telephone. The waiting list control group will receive the intervention after a period of 6 weeks. Exclusion criteria will be individuals who are at significant risk of harming themselves or others, who have a primary mental health disorder other than depression, or who have an intellectual disability that would hamper their ability to participate in the intervention. Effects of the treatment will be observed using outcomes in 3 domains: (1) clinical outcomes (symptom severity, recovery rate), (2) process variables (patient satisfaction, attendance, dropout), and (3) economic outcomes (cost and resource use). We will also examine mediators of outcomes in terms of patient variables (behavioral activation or inhibition motivation). We hypothesize that guided self-help behavioral activation will have a beneficial effect. RESULTS The study was approved by the research ethics committee of the Mental Health Center of Chongqing in November 2019. As of July 2020, recruitment had not yet begun. Data collection is expected to be completed by December 2020. Data analysis is expected to be completed by June 2021. Results will then be disseminated to patients, to the public, to clinicians, and to researchers through publications in journals and presentations at conferences. CONCLUSIONS This will be the first study in China to investigate guided self-help interventions for patients who are older adults and who are depressed, a group which is currently underrepresented in mental health research. The intervention is modular and adapted from an empirically supported behavioral activation treatment for depression. The generalizability and broad inclusion criteria are strengths. CLINICALTRIAL Chinese Clinical Trial Register ChiCTR1900026066; http://www.chictr.org.cn/showprojen.aspx?proj=43548 INTERNATIONAL REGISTERED REPORT PRR1-10.2196/18259

Download Full-text

Assessing the Efficacy and Acceptability of a Web-Based Intervention for Resilience Among College Students: Pilot Randomized Controlled Trial

JMIR Formative Research ◽

10.2196/20167 ◽

2020 ◽

Vol 4 (11) ◽

pp. e20167

Author(s):

Angel Enrique Roig ◽

Olwyn Mooney ◽

Alicia Salamanca-Sanabria ◽

Chi Tak Lee ◽

Simon Farrell ◽

...

Keyword(s):

Mental Health ◽

College Students ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Well Being ◽

Waiting List ◽

Web Based ◽

Randomized Controlled ◽

Automated Support ◽

Pilot Randomized Controlled Trial

Background College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. Objective This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. Methods A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor–Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. Results All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. Conclusions Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. Trial Registration International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034 International Registered Report Identifier (IRRID) RR2-10.1016/j.invent.2019.100254

Download Full-text

Assessing the Efficacy and Acceptability of a Web-Based Intervention for Resilience Among College Students: Pilot Randomized Controlled Trial (Preprint)

10.2196/preprints.20167 ◽

2020 ◽

Author(s):

Angel Enrique Roig ◽

Olwyn Mooney ◽

Alicia Salamanca-Sanabria ◽

Chi Tak Lee ◽

Simon Farrell ◽

...

Keyword(s):

Mental Health ◽

College Students ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Well Being ◽

Waiting List ◽

Web Based ◽

Randomized Controlled ◽

Automated Support ◽

Pilot Randomized Controlled Trial

BACKGROUND College students are at elevated risk for developing mental health problems and face specific barriers around accessing evidence-based treatment. Web-based interventions that focus on mental health promotion and strengthening resilience represent one possible solution. Providing support to users has shown to reduce dropout in these interventions. Further research is needed to assess the efficacy and acceptability of these interventions and explore the viability of automating support. OBJECTIVE This study investigated the feasibility of a new web-based resilience program based on positive psychology, provided with human or automated support, in a sample of college students. METHODS A 3-armed closed pilot randomized controlled trial design was used. Participants were randomized to the intervention with human support (n=29), intervention with automated support (n=26), or waiting list (n=28) group. Primary outcomes were resilience and well-being, respectively measured by the Connor–Davidson Resilience Scale and Pemberton Happiness Index. Secondary outcomes included measures of depression and anxiety, self-esteem, and stress. Outcomes were self-assessed through online questionnaires. Intention-to-treat and per-protocol analyses were conducted. RESULTS All participants demonstrated significant improvements in resilience and related outcomes, including an unexpected improvement in the waiting list group. Within- and between-group effect sizes ranged from small to moderate and within-group effects were typically larger for the human than automated support group. A total of 36 participants began the program and completed 46.46% of it on average. Participants were generally satisfied with the program and found it easy to use. CONCLUSIONS Findings support the feasibility of the intervention. Preliminary evidence for the equal benefit of human and automated support needs to be supported by further research with a larger sample. Results of this study will inform the development of a full-scale trial, from which stronger conclusions may be drawn. CLINICALTRIAL International Standard Randomized Controlled Trial Number (ISRCTN) 11866034; http://www.isrctn.com/ISRCTN11866034 INTERNATIONAL REGISTERED REPORT RR2-10.1016/j.invent.2019.100254

Download Full-text

Effect of an mHealth self‐help intervention on readmission after adult cardiac surgery: Protocol for a pilot randomized controlled trial

Journal of Advanced Nursing ◽

10.1111/jan.15104 ◽

2021 ◽

Author(s):

Rochelle Wynne ◽

Joanne Nolte ◽

Stacey Matthews ◽

Jennifer Angel ◽

Ann Le ◽

...

Keyword(s):

Randomized Controlled Trial ◽

Cardiac Surgery ◽

Controlled Trial ◽

Randomized Controlled ◽

Self Help ◽

Pilot Randomized Controlled Trial ◽

Adult Cardiac Surgery

Download Full-text

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

JMIR Research Protocols ◽

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

Download Full-text

StudiCare mindfulness—study protocol of a randomized controlled trial evaluating an internet- and mobile-based intervention for college students with no and “on demand” guidance

Trials ◽

10.1186/s13063-020-04868-0 ◽

2020 ◽

Vol 21 (1) ◽

Author(s):

Ann-Marie Küchler ◽

Dana Schultchen ◽

Olga Pollatos ◽

Morten Moshagen ◽

David D. Ebert ◽

...

Keyword(s):

Mental Health ◽

College Students ◽

Randomized Controlled Trial ◽

Controlled Trial ◽

Population Level ◽

Control Group ◽

Cognitive Fusion ◽

On Demand ◽

Randomized Controlled ◽

Increased Risk

Abstract Background College is an exciting but also challenging time with an increased risk for mental health issues. Only a minority of the college students concerned get professional help, a problem that might be improvable by internet- and mobile-based interventions (IMIs). However, adherence of IMIs is a concern. While guidance might be a solution, it is resource-intensive, derailing potential implementation on population level. The first aim of this trial is to evaluate the efficacy of the IMI StudiCare Mindfulness (StudiCare-M) for college students with “on demand” and no guidance. The second aim is to examine potential moderators and mediators, contributing to the questions of “how” and “for whom” such interventions work. Methods In this three-armed randomized controlled trial, both an unguided and “guidance on demand” (GoD) condition of StudiCare-M are compared to a waitlist control group. StudiCare-M is based on principles of acceptance and commitment therapy and stress management and consists of 7 modules plus two booster sessions. Participants in the GoD condition may ask their e-coach for support whenever needed. A total of 387 college students with moderate to low mindfulness are recruited at 15+ cooperating universities in Germany, Austria, and Switzerland via circular emails. Assessments take place before as well as 1, 2, and 6 months after randomization. The primary outcome is mindfulness. Secondary outcomes include stress, depression, anxiety, interoception, presenteeism, wellbeing, intervention satisfaction, adherence, and potential side effects. Among examined moderators and mediators are sociodemographic variables, pre-treatment symptomatology, treatment expectancy, self-efficacy, cognitive fusion, emotion regulation, and alexithymia. All data will be analyzed according to intention-to-treat (ITT) principles. Discussion Providing effective interventions to help college students become more resilient can make a valuable contribution to the health and functionality of future society. If effective under the condition of minimal or no guidance, StudiCare-M offers a low-threshold potentially resource-efficient possibility to enhance college student mental health on a population level. Moderation- and mediation analyses will deliver further insights for optimization of target groups and intervention content. Trial registration WHO International Clinical Trials Registry Platform via the German Clinical Studies Trial Register DRKS00014774. Registered on 18 May 2018.

Download Full-text