DepressionNCT05016154
Online Psychological Group Interventions
A study testing Online Group CBT intervention, SilverCloud guided and SilverCloud Unguided in people with Depression and Anxiety, run by University of Stellenbosch at 1 site in South Africa.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Depression, Anxiety
- What is being tested?
- Online Group CBT intervention, SilverCloud guided and SilverCloud Unguided
- Type of treatment
- Pill or oral medicine, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 400 participants
- Where
- 1 siteSouth Africa
- Study dates
- 26 Jul 2021to Dec 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 18 or older years.
- Enrolled as a student at Stellenbosch University.
- Provide Informed Consent.
- Access to internet to join the online group.
Who cannot join
- No internet availability.
- Did not provide Informed Consent
Trial locations and contacts
1 site in 1 country.
Jason Bantjes, PhD contact
South Africa1 site, 1 recruiting
- Recruiting
Stellenbosch University
Cape Town, Western Cape, 7550
Elsie Breet, PhD, 0760484289, elsie@sun.ac.za
Jason Bantjes, PhD, jbantjes@sun.ac.za
About this study
Official title: A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
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).
Read the 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.
- Conditions
- Depression, Anxiety
- Being tested
- Online Group CBT intervention, SilverCloud guided, SilverCloud Unguided, Mood Flow
- Keywords
- online group psychological intervention, depression, anxiety, online group Cognitive Behavioural Therapy, App-based interventions, Randomized controlled trial
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Online Group CBT interventionBehavioural
Group of participants complete 10 weeks of Online Group CBT intervention
SilverCloud guidedBehavioural
Group of participants make use of the SilverCloud guided app
SilverCloud UnguidedBehavioural
Group of participants make use of the SilverCloud Unguided app
Mood FlowBehavioural
Group of participants make use of the Mood Flow app
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Behavioral: Online Group CBT intervention |
| 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. Receives: Behavioral: SilverCloud guided |
| 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. Receives: Behavioral: SilverCloud Unguided |
| 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. Receives: Behavioral: Mood Flow |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: Baseline and 3-month follow up assessment for experiment and control interventions groups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2021
- Study start26 Jul 2021
- Primary completionJun 2022 (estimated)
- Study completionDec 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Stellenbosch
- Sponsor type
- University, hospital or other
- Collaborators
- Harvard University, West Virginia University
- Responsible party
- Principal investigator, Jason Bantjes, University of Stellenbosch
- Investigators
- Jason Bantjes, PhD, Principal investigator, University of Stellenbosch
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05016154
- Sponsor's protocol ID
- 12977
- Other IDs
- IRPSD-1681
- Status last verified
- Aug 2021
- First submitted
- 4 Aug 2021
- Last updated
- 23 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 34042598
Study at a glance
From the registry record, last updated by the sponsor on 23 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial of Online Group CBT for Symptoms of Depression and Anxiety Among University Students in South Africa
- ClinicalTrials.gov ID
- NCT05016154
- Acronym / sponsor ID
- 12977
- Conditions
- Depression, Anxiety
- Keywords
- online group psychological intervention, depression, anxiety, online group Cognitive Behavioural Therapy, App-based interventions, Randomized controlled trial
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- University of StellenboschUniversity, hospital or other
- Collaborators
- Harvard University, West Virginia University
- Study start
- 26 Jul 2021 (actual)
- Primary completion
- Jun 2022 (estimated)
- Study completion
- Dec 2022 (estimated)
- First posted
- 23 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Online group CBT intervention | Experimental | Behavioral: Online Group CBT interventionOnline 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 | Behavioral: SilverCloud guidedThe 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 | Behavioral: SilverCloud UnguidedThe 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 | Behavioral: Mood FlowThe 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 18 or older years.
- Enrolled as a student at Stellenbosch University.
- Provide Informed Consent.
- Access to internet to join the online group.
Key exclusion criteria (2 listed)
- No internet availability.
- Did not provide Informed Consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Online Group CBT interventionGroup of participants complete 10 weeks of Online Group CBT intervention | Behavioural | Online group CBT intervention |
| SilverCloud guidedGroup of participants make use of the SilverCloud guided app | Behavioural | SilverCloud guided |
| SilverCloud UnguidedGroup of participants make use of the SilverCloud Unguided app | Behavioural | SilverCloud unguided |
| Mood FlowGroup of participants make use of the Mood Flow app | Behavioural | Mood Flow |
Primary outcome
Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months.
Time frame: 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.
Time frame: 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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Aug 2021.
- Background: PubMed 34042598Bantjes 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jason Bantjes, PhD contact
Jason Bantjes, PhD principal investigator
University of Stellenbosch
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Online Group CBT intervention, SilverCloud guided and SilverCloud Unguided in people with Depression and Anxiety, run by University of Stellenbosch at 1 site in South Africa.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Africa. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Elsie Breet, PhD (0760484289, elsie@sun.ac.za), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline scores in the mean symptoms of depression as measured by the PHQ-9 at 3-months. (time frame: Baseline and 3-month follow up assessment for experiment and control interventions groups.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05016154, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Aug 2021.