Online Psychological Group Interventions

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05016154
• Other study ID #: 12977
• Secondary ID: IRPSD-1681
• Status: Recruiting
• Phase: N/A
• Start date: July 26, 2021
• Est. completion date: December 2022

Study information

• Verified date: August 2021
• Source: University of Stellenbosch
• Contact: Elsie Breet, PhD
• Phone: 0760484289
• Email: elsie[@]sun.ac.za
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 2022
• Est. primary completion date: June 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Anxiety
• Anxiety Disorders
• Depression
• Depressive Disorder

Intervention

Behavioral:
• Online Group CBT intervention
Group of participants complete 10 weeks of Online Group CBT intervention
• SilverCloud guided
Group of participants make use of the SilverCloud guided app
• SilverCloud Unguided
Group of participants make use of the SilverCloud Unguided app
• Mood Flow
Group of participants make use of the Mood Flow app

Locations

Country	Name	City	State
South Africa	Stellenbosch University	Cape Town	Western Cape

Sponsors (3)

Lead Sponsor	Collaborator
University of Stellenbosch	Harvard University, West Virginia University

Country where clinical trial is conducted

South Africa, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.
Primary	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.