Online Psychological Group Interventions
A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
2 other identifiers
interventional
400
1 country
1
Brief Summary
The aim is to assess the effectiveness of online group CBT for reducing symptoms of depression and anxiety among university students. The investigators will conduct a four-arm randomised control trial comparing a 10-session online group CBT intervention to three mental health apps (namely SilverCloud guided, SilverCloud unguided, and Mood Flow).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable depression
Started Jul 2021
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
July 26, 2021
CompletedFirst Submitted
Initial submission to the registry
August 4, 2021
CompletedFirst Posted
Study publicly available on registry
August 23, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2022
CompletedAugust 23, 2021
August 1, 2021
10 months
August 4, 2021
August 17, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of depression, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).
Baseline and 3-month follow up assessment for experiment and control interventions groups.
Change from baseline scores in the mean symptoms of anxiety as measured by the GAD-7 at 3-months.
Determine if a 10-week online group CBT (GCBT) intervention effectively reduces mean scores of anxiety, between baseline and 3-month follow up, among university students when compared with three control group interventions (i.e., Mood Flow, SilverCloud guided, and SilverCloud unguided).
Baseline and 3-month follow up assessment for experiment and control interventions groups.
Study Arms (4)
Online group CBT intervention
EXPERIMENTALOnline group CBT delivered via Microsoft Teams (a secure web-based video conferencing platform) in 10 weekly workshops of 60-75 minutes.
SilverCloud guided
ACTIVE COMPARATORThe SilverCloud app is a set of programs and courses that can be completed on a phone, tablet or computer. Students are also contacted by the SilverCloud support team which offers them guidance and support while using the app. Silvercloud uses principles borrowed from both a popular type of counseling called Cognitive Behavioral Therapy (CBT) and Mindfulness. Each module takes approximately 40minutes to complete. Students are encouraged to complete at least one module per week.
SilverCloud unguided
ACTIVE COMPARATORThe SilverCloud app is a set of programs and courses that can be completed on a phone, tablet or computer. Students are encouraged to use the app as they see fit, although guidelines to using the app are provided. Silvercloud uses principles borrowed from both a popular type of counseling called Cognitive Behavioral Therapy (CBT) and Mindfulness. Each module takes approximately 40minutes to complete. Students are encouraged to complete at least one module per week.
Mood Flow
ACTIVE COMPARATORThe Moodflow app is a mood tracker and journal that helps students figure out what changes their mood. Students are encouraged to use the app as they see fit, although guidelines to using the app are provided.
Interventions
Group of participants complete 10 weeks of Online Group CBT intervention
Group of participants make use of the SilverCloud guided app
Group of participants make use of the SilverCloud Unguided app
Eligibility Criteria
You may qualify if:
- Aged 18 or older years.
- Enrolled as a student at Stellenbosch University.
- Provide Informed Consent.
- Access to internet to join the online group.
You may not qualify if:
- No internet availability.
- Did not provide Informed Consent
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University of Stellenboschlead
- Harvard Universitycollaborator
- West Virginia Universitycollaborator
Study Sites (1)
Stellenbosch University
Cape Town, Western Cape, 7550, South Africa
Related Publications (1)
Bantjes J, Kazdin AE, Cuijpers P, Breet E, Dunn-Coetzee M, Davids C, Stein DJ, Kessler RC. A Web-Based Group Cognitive Behavioral Therapy Intervention for Symptoms of Anxiety and Depression Among University Students: Open-Label, Pragmatic Trial. JMIR Ment Health. 2021 May 27;8(5):e27400. doi: 10.2196/27400.
PMID: 34042598BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Jason Bantjes, PhD
University of Stellenbosch
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Professor
Study Record Dates
First Submitted
August 4, 2021
First Posted
August 23, 2021
Study Start
July 26, 2021
Primary Completion
June 1, 2022
Study Completion
December 1, 2022
Last Updated
August 23, 2021
Record last verified: 2021-08
Data Sharing
- IPD Sharing
- Will not share