Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
400 participants
INTERVENTIONAL
2021-07-26
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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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.
Online Group CBT intervention
Group of participants complete 10 weeks of Online Group CBT intervention
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 guided
Group of participants make use of the SilverCloud guided app
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.
SilverCloud Unguided
Group of participants make use of the SilverCloud Unguided app
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.
Mood Flow
Group of participants make use of the Mood Flow app
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
2. Enrolled as a student at Stellenbosch University.
3. Provide Informed Consent.
4. Access to internet to join the online group.
Exclusion Criteria
2. Did not provide Informed Consent
18 Years
ALL
No
Sponsors
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Harvard University
OTHER
West Virginia University
OTHER
University of Stellenbosch
OTHER
Responsible Party
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Jason Bantjes
Professor
Principal Investigators
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Jason Bantjes, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Stellenbosch
Locations
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Stellenbosch University
Cape Town, Western Cape, South Africa
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Provided Documents
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Document Type: Study Protocol and Statistical Analysis Plan
Other Identifiers
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IRPSD-1681
Identifier Type: OTHER
Identifier Source: secondary_id
12977
Identifier Type: -
Identifier Source: org_study_id
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