Online group cognitive behavioural therapy for South African university students with depression and anxiety
| ISRCTN | ISRCTN47089643 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN47089643 |
- Submission date
- 16/08/2022
- Registration date
- 11/10/2023
- Last edited
- 01/11/2023
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Mental and Behavioural Disorders
Plain English Summary
Background and study aims
The aim of this study is to find out whether undergraduate university students with mild-to-moderate symptoms of depression and/or anxiety who receive an online group cognitive behavioural therapy (GCBT) intervention report lower rates of symptoms of depression and/or anxiety than control groups who receive self-guided digital interventions. The online GCBT intervention has been developed with content that is drawn from common elements identified from GCBT interventions shown to be effective for university students.
Who can participate?
Undergraduate students aged 18 years or older from a selection of five universities across South Africa with mild-to-moderate symptoms of depression and/or anxiety
What does the study involve?
After baseline data collection, students who indicate mild-to-moderate symptoms of depression and/or anxiety will be randomly allocated into the intervention or control group. The intervention will be delivered via Microsoft Teams (a secure web-based video conferencing platform) in 10 weekly workshops of 60-75 minutes. The participants will be provided with electronic interactive pdf workbooks consisting of exercises and brief summaries of the main ideas and skills for each session before each workshop. Sessions will be facilitated by mental health practitioners under the supervision of a registered PhD psychologist. The control groups will be assigned to make use of either a mood monitoring smartphone application called MoodFlow, or a smartphone-based self-help tool called SuperBetter, both of which are freely available digital interventions. Follow-up data collection will occur 3, 6 and 12 months after the end of the intervention (counted from the last day of intervention delivery).
What are the possible benefits and risks of participating?
Due to the nature of psychotherapeutic interventions, there is a risk of participants experiencing emotional distress during the GCBT programme. Participants will be provided with contact details for additional mental health services. Participants within the control group may also experience distress during the study and will be provided with the same list of mental health resources as the intervention participants. Benefits of participation include potential therapeutic effects of the interventions (both control and interventions), namely a decrease in symptoms of depression and anxiety.
Where is the study run from?
Stellenbosch University (South Africa)
When is the study starting and how long is it expected to run for?
May 2022 to May 2024
Who is funding the study?
National Research Foundation (South Africa)
Who is the main contact?
1. Dr Xanthe Hunt, xanthe@sun.ac.za
2. Prof. Jason Bantjes, Jason.Bantjes@mrc.ac.za
Contact information
Principal Investigator
Room 4009, Education Building
Faculty of Medicine and Health Sciences
Stellenbosch University
Cape Town
7505
South Africa
 ORCID ID |
0000-0001-7531-6665 |
|---|---|
| Phone | +27 (0)21 938 9451 |
| xanthe@sun.ac.za |
Principal Investigator
SA MRC
Francie van Zijl Drive
Parowvallei
Cape Town
7505
South Africa
| ORCID ID |
0000-0002-3626-9883 |
|---|---|
| Phone | +27 (0)21 938 9451 |
| Jason.Bantjes@mrc.ac.za |
Study information
| Study design | Multi-site parallel-group randomized controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised parallel trial |
| Study setting(s) | Other |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | A randomised controlled trial of an online group cognitive behavioural therapy intervention for South African students with depression and anxiety |
| Study hypothesis | Undergraduate university students with mild-to-moderate symptoms of depression and/or anxiety who receive an online group cognitive behavioural therapy (GCBT) intervention will report significantly lower rates of symptoms of depression and/or anxiety than control groups who receive self-guided digital interventions. |
| Ethics approval(s) | Approved 14/06/2022, Health Research Ethics Committee of Stellenbosch University (Education Building, Tygerberg Campus, Faculty of Medicine and Health Sciences, Francie van Zijl Drive, Tygerberg 7505, Netherlands; +27 (0)21 938 9075; blanchep@sun.ac.za), ref: N22/04/047 |
| Condition | Mild-to-moderate symptoms of depression and anxiety |
| Intervention | The trial will take place across between three and five of the following universities: Stellenbosch University (SU), the University of the Free State (UFS), the University of Cape Town (UCT), the University of the Western Cape (UWC), Rhodes University (RU), and the University of the Witwatersrand (Wits). In participating universities, the email addresses of all undergraduate students will be obtained via institutional permission processes. An email invitation will be sent to randomized batches of students, who, after completing a baseline assessment meet the inclusion criteria, will be randomized using block randomization, into either the intervention or control conditions. Intervention group recipients will receive a 10-week online GCBT intervention. Control groups will be assigned to self-guided digital interventions. Follow-up will occur 3, 6 and 12 months after the end of the intervention (counted from the last day of intervention delivery). The intervention targets undergraduate university students who have mild-to-moderate symptoms of depression and anxiety. These mood disorders are associated with academic failure, severe role impairment and suicide. Self-guided and guided digital interventions have been touted as scalable and cost-effective treatments for university students. However, they have been shown to have high rates of attrition and low rates of engagement. The active condition is digital GCBT which includes a) online group-based sessions facilitated by a mental health practitioner, and b) materials for intervention which are implemented during sessions and can be referenced after the group intervention is completed. The intervention consists of 10 sessions over a 10-week period. Control groups will be assigned to self-guided digital interventions, both of which are mental health apps including Moodflow (https://www.moodflow.co/) and Superbetter (https://www.superbetter.com/). These students will also have access to a list of mental health resources if further support is required. |
| Intervention type | Behavioural |
| Primary outcome measure | Self-reported depression and anxiety symptoms measured using the Patient Health Questionnaire-9 (PHQ-9) and the Generalised Anxiety Disorder Assessment (GAD-7) at baseline, 3, 6 and 12 months |
| Secondary outcome measures | 1. Attention and concentration: Standardised survey instrument to measure attention and concentration from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 2. Substance use: Standardised survey instrument to measure substance use from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 3. Panic attacks: Standardised survey instrument to measure symptoms of panic from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 4. Social anxiety: Standardised survey instrument to measure symptoms of social anxiety from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 5. High mood: Standardised survey instrument to measure symptoms of high mood (or ‘mania’) from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 6. Obsessive-compulsive disorder: Standardised survey instrument to measure symptoms of obsessive-compulsive disorder from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 7. Stressful experiences: Standardised survey instrument to measure symptoms of PTSD and exposure to stressful life events from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 8. Other behavioural health problems: Standardised survey instrument to measure symptoms of disordered eating and dissociation from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months 9. Self-harm: Standardised survey instrument to assess the presence of self-harm behaviours and suicidality from The Composite International Diagnostic Interview Screening Scales (CIDI‐SC) at baseline, 3, 6 and 12 months |
| Overall study start date | 01/05/2022 |
| Overall study end date | 01/05/2024 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 210 |
| Participant inclusion criteria | 1. Aged 18 years or older 2. Enrolled as an undergraduate student at one of the target institutions 3. Provide Informed Consent 4. Access to the internet to join the online group 5. Report mild-to-moderate symptoms of depression and/or anxiety (taken as a symptom threshold of 10 or above on both scales) |
| Participant exclusion criteria | 1. No internet availability 2. Students who report active suicidality with intent will be referred to appropriate campus-based crises services, national suicide helplines, and any additional referral sites specified by the local administration 3. Students who do not have at least mild-to-moderate symptoms of depression and/or anxiety will also be excluded but given advice about how to access informational resources about mental health, and will not be followed up |
| Recruitment start date | 17/08/2022 |
| Recruitment end date | 31/08/2022 |
Locations
Countries of recruitment
- South Africa
Study participating centres
Francie van Zyl Drive
Cape Town
7505
South Africa
Park West
Bloemfontein
9301
South Africa
Cape Town
7535
South Africa
Cape Town
7701
South Africa
Grahamstown
6139
South Africa
Braamfrontin
Johannesburg
2000
South Africa
Sponsor information
University/education
Francie van Zyl Drive
Cape Town
7505
South Africa
| Phone | +27 (0)21 938 9075 |
|---|---|
| blanchep@sun.ac.za | |
| Website | http://www.sun.ac.za/english |
"ROR" |
https://ror.org/05bk57929 |
Funders
Funder type
Research organisation
Government organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- South Africa’s National Research Foundation, National Research Foundation (South Africa), NRF
- Location
- South Africa
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Data sharing statement to be made available at a later date |
| Publication and dissemination plan | Planned publications include a protocol paper, as well as description of the results of the trial in high-impact peer-reviewed journals and conferences; further, feedback to university counselling centres in South Africa about the outcomes, including the sharing of the intervention materials and assisting staff to implement the intervention (if found to be effective). |
| IPD sharing plan | The data-sharing plans for the current study are unknown and will be made available at a later date. |
Editorial Notes
01/11/2023: This record was submitted on 17/08/2022 and was complete and ready for publication on 18/08/2022. However, it was not registered until 11/10/2023 because of delayed payment of the ISRCTN registration fee.
13/10/2023: Internal review.
18/08/2022: Trial's existence confirmed by the Health Research Ethics Committee of Stellenbosch University.
