Not provided
| ID | Type | Description | Link |
|---|---|---|---|
| IRPSD-1681 | Other Identifier | Stellenbosch University |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Harvard University | OTHER |
| West Virginia University | OTHER |
Not provided
Not provided
Not provided
Not provided
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).
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Online group CBT intervention | Experimental | Online group CBT delivered via Microsoft Teams (a secure web-based video conferencing platform) in 10 weekly workshops of 60-75 minutes. |
|
| SilverCloud guided | Active Comparator | 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 | Active Comparator | 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 | Active Comparator | 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. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Online Group CBT intervention | Behavioral | Group of participants complete 10 weeks of Online Group CBT intervention |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
| 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Elsie Breet, PhD | Contact | 0760484289 | elsie@sun.ac.za | |
| Jason Bantjes, PhD | Contact | jbantjes@sun.ac.za |
| Name | Affiliation | Role |
|---|---|---|
| Jason Bantjes, PhD | University of Stellenbosch | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stellenbosch University | Recruiting | Cape Town | Western Cape | 7550 | South Africa |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34042598 | Background | 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. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Aug 3, 2021 | Aug 11, 2021 | Prot_SAP_000.pdf |
Not provided
| ID | Term |
|---|---|
| D003863 | Depression |
| D001008 | Anxiety Disorders |
| ID | Term |
|---|---|
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D001523 | Mental Disorders |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| SilverCloud guided | Behavioral | Group of participants make use of the SilverCloud guided app |
|
| SilverCloud Unguided | Behavioral | Group of participants make use of the SilverCloud Unguided app |
|
| Mood Flow | Behavioral | Group of participants make use of the Mood Flow app |
|