Clinical trial NCT05016154: Online Psychological Group Interventions
Official title: A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Depression
Anxiety
Keywords: online group psychological intervention
depression
anxiety
online group Cognitive Behavioural Therapy
App-based interventions
Randomized controlled trial
Lead sponsor: University of Stellenbosch
Sponsor class: OTHER
Collaborators: name: Harvard University
name: West Virginia University
First posted: 2021-08-23
Enrollment: 400
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Aged 18 or older years.
2. Enrolled as a student at Stellenbosch University.
3. Provide Informed Consent.
4. Access to internet to join the online group.

Exclusion Criteria:

1. No internet availability.
2. Did not provide Informed Consent

Primary outcomes:
measure: Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
timeFrame: Baseline and 3-month follow up assessment for experiment and control interventions groups.
measure: Change from baseline scores in the mean symptoms of anxiety as measured by the GAD-7 at 3-months.
timeFrame: Baseline and 3-month follow up assessment for experiment and control interventions groups.
Secondary outcomes:
Other outcomes:
Locations:
city: Cape Town
country: South Africa
facility: Stellenbosch University
state: Western Cape
Study officials:
affiliation: University of Stellenbosch
name: Jason Bantjes, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.