Online Psychological Group Interventions

Not Applicable

• Conditions: Anxiety; Depression
• Interventions: Behavioral: Online Group CBT intervention; Behavioral: SilverCloud guided; Behavioral: SilverCloud Unguided; Behavioral: Mood Flow

• Registration Number: NCT05016154
• Lead Sponsor: University of Stellenbosch

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 Timeline

• Study Start: 2021-07-26
• Status Verified: 2021-08
• Study First Submitted: 2021-08-04
• Study First Submitted QC: 2021-08-17
• Last Update Submitted: 2021-08-17
• Study First Posted: 2021-08-23
• Last Update Posted: 2021-08-23
• Primary Completion: 2022-06
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Online group CBT intervention	Online Group CBT intervention	Online group CBT delivered via Microsoft Teams (a secure web-based video conferencing platform) in 10 weekly workshops of 60-75 minutes.
SilverCloud guided	SilverCloud guided	The 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	SilverCloud Unguided	The 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	Mood Flow	The 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.

Primary Outcome Measures

Name	Time	Method
Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.	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.	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).

Trial Locations

Locations (1)

Stellenbosch University; 🇿🇦 Cape Town, Western Cape, South Africa