A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- University of Stellenbosch
- Enrollment
- 400
- Locations
- 2
- Primary Endpoint
- Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
Study Overview
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).
Detailed Description
Email invitations and information about the study will be sent to random samples of students inviting those with symptoms of depression, anxiety, or stress to join the trial.
Students who express interest will be asked to complete an online consent form (providing more detailed information about the study and explaining potential risks and benefits of participation), following which they will complete a baseline assessment. Students who meet inclusion criteria will then be randomly allocated to one of four interventions. Follow-up assessments will be done at 3-, 6- and 12-months post intervention.
The baseline assessment will include measures of depression and anxiety, as well as factors that could potentially predict treatment responses (such as gender, age, substance use, self-harm, adverse childhood experiences, and physical health). Follow-up assessments will include measures of depression and anxiety, as well as substance use, self-harm, and treatment seeking.
The primary outcomes will be symptoms of depression and anxiety as measured by the GAD-7 and PHQ-9.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Aged 18 or older years.
- •Enrolled as a student at Stellenbosch University.
- •Provide Informed Consent.
- •Access to internet to join the online group.
Exclusion Criteria
- •No internet availability.
- •Did not provide Informed Consent
Outcomes
Primary Outcomes
Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
Time Frame: Baseline and 3-month follow up assessment for experiment and control interventions groups.
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).
Change from baseline scores in the mean symptoms of anxiety as measured by the GAD-7 at 3-months.
Time Frame: Baseline and 3-month follow up assessment for experiment and control interventions groups.
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).
Secondary Outcomes
No secondary outcomes reported
Investigators
Jason Bantjes
Professor
University of Stellenbosch