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

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

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

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

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

BACKGROUND University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. OBJECTIVE The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. METHODS This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. RESULTS The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. CONCLUSIONS The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. CLINICALTRIAL Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 INTERNATIONAL REGISTERED REPORT DERR1-10.2196/21307

scholarly journals The Web-Based Uprise Program for Mental Health in Australian University Students: Protocol for a Pilot Randomized Controlled Trial

10.2196/21307 ◽  
2020 ◽  
Vol 9 (12) ◽  
pp. e21307
Author(s):  
Karra D Harrington ◽  
Robert Eres ◽  
Michelle H Lim
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
University Students ◽  
Health Program ◽  
Controlled Trial ◽  
Mental Health Program ◽  
Web Based ◽  
Safety And Efficacy ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

Background University students are vulnerable to poor mental health, psychological distress, and loneliness relative to nonuniversity student peers. However, the rate of seeking mental health treatment among university students is low. Web-based psychological interventions may provide an opportunity for supporting vulnerable university students who are unlikely to otherwise seek support. Objective The aim of this study is to examine the feasibility, acceptability, safety, and efficacy of an existing web-based transdiagnostic cognitive behavioral therapy (CBT) mental health program for use among Australian university students. Methods This is a pilot randomized controlled trial comparing a self-directed web-based CBT mental health program with a waitlist control. The self-directed modules will be augmented with optional webchat or telephone coaching with a therapist. The recruitment target is 70 university students who do not present with a clinical mental health disorder. Allocation will be made in a 1:1 ratio and will occur after the initial baseline assessment. Assessments will be completed at baseline, upon completion of a 4-week waitlist (waitlist group only), upon completion of the program, and at 3 months after completion of the program. Results The trial was funded in June 2018, and the protocol was approved by the Swinburne University Human Research Ethics Committee in September 2018. Recruitment commenced in October 2018, with the first participant allocated in November 2018. A total of 70 participants were recruited to the trial. The trial recruitment ceased in June 2019, and data collection was finalized in December 2019. We expect the final data analysis to be completed by November 2020 and results to be published early in 2021. The primary outcomes are feasibility, acceptability, safety, and symptoms of depression, anxiety, and stress. The secondary outcomes are psychological wellbeing, quality of life, loneliness, self-reported physical health status, emotion regulation, and cognitive and mindfulness processes. Conclusions The acceptability, feasibility, safety, and efficacy of a web-based mental health program in university students will be evaluated. Web-based mental health programs offer the opportunity to engage university students who may be reluctant to seek support through traditional face-to-face mental health services, and the transdiagnostic approach of the program has the potential to address the breadth of mental health concerns of university students. Trial Registration Australian New Zealand Clinical Trial Registry ACTRN12618001604291; https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?ACTRN=12618001604291 International Registered Report Identifier (IRRID) DERR1-10.2196/21307

scholarly journals Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial (Preprint)

2020 ◽  
Author(s):  
Emma Bruehlman-Senecal ◽  
Cayce J Hook ◽  
Jennifer H Pfeifer ◽  
Caroline FitzGerald ◽  
Brittany Davis ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
College Adjustment ◽  
Controlled Trial ◽  
Smartphone App ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial ◽  
Adjustment Outcomes

BACKGROUND Loneliness is a widespread and significant problem on college campuses. Prolonged loneliness in young adulthood is a risk factor for concurrent and future mental health problems and attrition, making college a critical time for support. Cognitive and behavioral interventions show promise for decreasing loneliness and can be widely disseminated through technology. OBJECTIVE This pilot randomized controlled trial was conducted to examine the initial efficacy, feasibility, and desirability of a smartphone app, Nod, designed to deliver cognitive and behavioral skill-building exercises to reduce loneliness during the transition to college. METHODS First-year college students (N=221, mean age 18.7 years, 59% female) were recruited online during incoming student orientation, and randomized to either receive immediate access to Nod (experimental group, n=100) or access after 4 weeks (control group, n=121). The app delivered skills via fully automated (1) “social challenges,” suggested activities designed to build social connections; (2) reflections, brief cognitive reframing exercises; and (3) student testimonials that encouraged a growth mindset toward social connection building. Main intention-to-treat analyses were used to compare the conditions on self-assessed loneliness, depressive symptoms, and other mental health and college adjustment outcomes at week 4, controlling for baseline values on those variables. Analyses were also performed to test the hypothesis that the treatment benefits would be particularly pronounced for participants with heightened psychological vulnerability at baseline (ie, higher baseline depressive symptoms and loneliness). RESULTS Retention was 97% at week 4, and participants viewed an average 36.7 pages of app content. There were no significant condition differences in loneliness at week 4 (<i>F</i><sub>1, 211</sub>=0.05, <i>P=</i>.82; η<sub>p</sub><sup>2</sup> &lt;.001). However, there was a significant condition-by-baseline depression interaction to predict week-4 loneliness (<i>F</i><sub>1,209</sub>=9.65, <i>P=</i>.002; η<sub>p</sub><sup>2</sup> =.04). Simple slope analyses indicated that baseline depression positively predicted week-4 loneliness among control participants (<i>r</i>=0.30, t<sub>209</sub>=3.81, <i>P</i>&lt;.001), but not among experimental participants (<i>r</i>=–0.09, t<sub>209</sub>=–0.84, <i>P</i>=.40), suggesting that Nod buffered participants with high baseline depression scores from experiencing heightened midquarter loneliness. Similarly, there were no significant condition differences in other week-4 outcomes. However, moderation by baseline vulnerability was found for week-4 depressive symptoms, sleep quality, and indices of college adjustment (eg, perceived social support and campus belonging). CONCLUSIONS Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students. The results of this trial suggest that cognitive and behavioral skills delivered via a mobile app can buffer psychologically vulnerable college students against heightened loneliness and depressive symptoms, as well as other negative college adjustment outcomes. Future work will aim to improve upon app engagement, and to address loneliness among other key populations. CLINICALTRIAL ClinicalTrials.gov NCT04164654; https://clinicaltrials.gov/ct2/show/NCT04164654

scholarly journals Smartphone App to Address Loneliness Among College Students: Pilot Randomized Controlled Trial

10.2196/21496 ◽  
2020 ◽  
Vol 7 (10) ◽  
pp. e21496
Author(s):  
Emma Bruehlman-Senecal ◽  
Cayce J Hook ◽  
Jennifer H Pfeifer ◽  
Caroline FitzGerald ◽  
Brittany Davis ◽  
...  
Keyword(s):  
Mental Health ◽  
College Students ◽  
Randomized Controlled Trial ◽  
Depressive Symptoms ◽  
College Adjustment ◽  
Controlled Trial ◽  
Smartphone App ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial ◽  
Adjustment Outcomes

Background Loneliness is a widespread and significant problem on college campuses. Prolonged loneliness in young adulthood is a risk factor for concurrent and future mental health problems and attrition, making college a critical time for support. Cognitive and behavioral interventions show promise for decreasing loneliness and can be widely disseminated through technology. Objective This pilot randomized controlled trial was conducted to examine the initial efficacy, feasibility, and desirability of a smartphone app, Nod, designed to deliver cognitive and behavioral skill-building exercises to reduce loneliness during the transition to college. Methods First-year college students (N=221, mean age 18.7 years, 59% female) were recruited online during incoming student orientation, and randomized to either receive immediate access to Nod (experimental group, n=100) or access after 4 weeks (control group, n=121). The app delivered skills via fully automated (1) “social challenges,” suggested activities designed to build social connections; (2) reflections, brief cognitive reframing exercises; and (3) student testimonials that encouraged a growth mindset toward social connection building. Main intention-to-treat analyses were used to compare the conditions on self-assessed loneliness, depressive symptoms, and other mental health and college adjustment outcomes at week 4, controlling for baseline values on those variables. Analyses were also performed to test the hypothesis that the treatment benefits would be particularly pronounced for participants with heightened psychological vulnerability at baseline (ie, higher baseline depressive symptoms and loneliness). Results Retention was 97% at week 4, and participants viewed an average 36.7 pages of app content. There were no significant condition differences in loneliness at week 4 (F1, 211=0.05, P=.82; ηp2 <.001). However, there was a significant condition-by-baseline depression interaction to predict week-4 loneliness (F1,209=9.65, P=.002; ηp2 =.04). Simple slope analyses indicated that baseline depression positively predicted week-4 loneliness among control participants (r=0.30, t209=3.81, P<.001), but not among experimental participants (r=–0.09, t209=–0.84, P=.40), suggesting that Nod buffered participants with high baseline depression scores from experiencing heightened midquarter loneliness. Similarly, there were no significant condition differences in other week-4 outcomes. However, moderation by baseline vulnerability was found for week-4 depressive symptoms, sleep quality, and indices of college adjustment (eg, perceived social support and campus belonging). Conclusions Although Nod exposure did not impact outcomes for the full sample, these results provide initial evidence of its benefit for vulnerable students. The results of this trial suggest that cognitive and behavioral skills delivered via a mobile app can buffer psychologically vulnerable college students against heightened loneliness and depressive symptoms, as well as other negative college adjustment outcomes. Future work will aim to improve upon app engagement, and to address loneliness among other key populations. Trial Registration ClinicalTrials.gov NCT04164654; https://clinicaltrials.gov/ct2/show/NCT04164654

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

2020 ◽  
Author(s):  
Xiaoxia Wang ◽  
Xiaoyan Zhou ◽  
Hui Yang
Keyword(s):  
Mental Health ◽  
Randomized Controlled Trial ◽  
Behavioral Activation ◽  
Controlled Trial ◽  
Waiting List ◽  
Control Group ◽  
Randomized Controlled ◽  
Depressed Patients ◽  
Self Help ◽  
Pilot Randomized Controlled Trial

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.

scholarly journals The Effectiveness of Web-Based Asthma Self-Management System, My Asthma Portal (MAP): A Pilot Randomized Controlled Trial

2016 ◽  
Vol 18 (12) ◽  
pp. e313 ◽  
Author(s):  
Sara Ahmed ◽  
Pierre Ernst ◽  
Susan J Bartlett ◽  
Marie-France Valois ◽  
Tasneem Zaihra ◽  
...  
Keyword(s):  
Randomized Controlled Trial ◽  
Management System ◽  
Controlled Trial ◽  
Self Management ◽  
Web Based ◽  
Randomized Controlled ◽  
Pilot Randomized Controlled Trial

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

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