Online Psychological Group Interventions

Sponsor

University of Stellenbosch (Other)

Overall Status

Recruiting

CT.gov ID

NCT05016154

Collaborator

Harvard University (Other), West Virginia University (Other)

400

Enrollment

Location

Arms

16.2

Anticipated Duration (Months)

24.7

Patients Per Site Per Month

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Depression Anxiety	Behavioral: Online Group CBT intervention Behavioral: SilverCloud guided Behavioral: SilverCloud Unguided Behavioral: Mood Flow	N/A

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

Anticipated Enrollment :

400 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa

Actual Study Start Date :

Jul 26, 2021

Anticipated Primary Completion Date :

Jun 1, 2022

Anticipated Study Completion Date :

Dec 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Behavioral: Online Group CBT intervention Group of participants complete 10 weeks of Online Group CBT intervention
Active Comparator: 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.	Behavioral: SilverCloud guided Group of participants make use of the SilverCloud guided app
Active Comparator: 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.	Behavioral: SilverCloud Unguided Group of participants make use of the SilverCloud Unguided app
Active Comparator: 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.	Behavioral: Mood Flow Group of participants make use of the Mood Flow app

Outcome Measures

Primary Outcome Measures

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).