Mental HealthNCT05187689
Mental Health Literacy and Mental Health Promotion With Urban Refugee Youth in Kampala, Uganda
A study testing VR + MHL intervention and Group PM+ in people with Mental Health, run by University of Toronto.
Trial summary
From our previous studies, we know that urban refugee youth commonly report depressive symptoms. The primary aim of this study is to compare the effectiveness of youth-tailored interventions to improve mental health literacy and reduce mental health stigma among urban refugee youth in Kampala, Uganda. Read more about this study
- Who is it for?
- Ages 16 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Mental Health
- What is being tested?
- VR + MHL intervention and Group PM+
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 330 participants
- Where
- No sites listed yet
- Study dates
- 31 Jan 2022to 27 May 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 16 to 25 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- living in one of the 5 informal settlements in Kampala we already work with (Nsambya, Katwe, Rubaga, Kabalagala, Kansanga);
- self identify as a woman or man (transgender inclusive);
- identify as a refugee/displaced person/having refugee parents;
- aged 16-25;
- own a mobile phone;
- speak Swahili, Luganda, Kirundi, Kinyarwanda, French or English and can provide informed consent.
Who cannot join
- -
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Tushirikiane4MH: Mental Health Literacy and Mental Health Promotion With Urban Refugee Youth in Kampala, Uganda
From our previous studies, we know that urban refugee youth commonly report depressive symptoms. The primary aim of this study is to compare the effectiveness of youth-tailored interventions to improve mental health literacy and reduce mental health stigma among urban refugee youth in Kampala, Uganda. There will be two intervention arms and one control arm. The first intervention arm will involve a VR experience that focuses on mental health literacy and coping strategies, as well as SMS check-ins from peer navigators (PN) trained in psychological first aid. The second intervention arm will involve an adapted version of the WHO's Group Problem Management Plus. The primary outcomes are to a) increase mental health literacy (knowledge and understanding of mental health generally and of specific disorders; b) increase attitudes towards mental health help-seeking, c) reduce depression, d) increase adaptive coping strategies; e) reduce mental health stigma, f) improve mental wellbeing, and g) increase level of functioning. Participants will complete a pre- and post-intervention survey as well as a follow-up survey.
- Conditions
- Mental Health
- Being tested
- VR + MHL intervention, Group PM+
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
VR + MHL interventionBehavioural
The intervention will include: 1) a Virtual Reality (VR) interactive and immersive 30-minute session viewed using a low cost VR headset; and 2) an 8-week program of weekly WelTel SMS check-ins managed by Peer Navigators (PNs), weekly WelTel SMS blasts informed by Psychological First Aid (PFA) with mental health literacy (MHL) messages developed with PN, and weekly WelTel web-based secure platform social group discussions on MHL, stress coping, and stigma moderated by PN alongside a trained Coordinator. Weekly MHL WelTel platform moderated discussion foci will address MHL, stigma and stress coping strategies, including self-compassion and other strategies that emerge from the urban refugee youth interviews and focus groups, through diverse methods, including: 'scenarios' mimicking real life situations; a 'question box'; sharing photos demonstrating stress coping strategies; memes; songs; and ways participants interrupted stigma in their daily lives.
Group PM+Behavioural
Participants will attend small groups (5-6 participants with a PN and a coordinator supporting) outdoors with physically distancing, for Group PM+ sessions following the adapted WHO Group-PM+ manual (adaptations made in Phase 1 explain above) 5 weekly 3-hour sessions delivered by PN who will co-facilitate sessions with the Coordinator. Each session has a mechanism of action:
- Managing stress: mechanism of action-identify goals, learn deep breathing and techniques for stress management
- Managing problems: mechanism of action-identify 1 solvable practical problem, brainstorm possible solutions together
- Get going, keep doing: mechanism of action-learn about depression and inactivity, identify and plan small enjoyable activities
- Strengthen social support: mechanism of action-discuss a range of social support resources, make plan to increase social support
- Staying well: mechanism of action- this session reviews all of the mechanisms of action in the prior 4 sessions
| Study group | Role | What they receive |
|---|---|---|
| Virtual reality and mental health literacy intervention | Experimental | This arm will participate in an interactive virtual reality experience to learn and practice mental health literacy and psychological first aid skills, supplemented by mhealth SMS with informational bidirectional messages. Receives: Behavioral: VR + MHL intervention |
| Group Problem Management+ and VR/mental health literacy | Experimental | This arm will participate in an interactive virtual reality experience to learn and practice mental health literacy and psychological first aid skills, supplemented by mhealth SMS with informational bidirectional messages. This arm will also participate in an 5-week Group Problem Management Plus intervention, a group based problem solving intervention. Receives: Behavioral: Group PM+ |
| Control | No intervention | This is a waitlist control. After Arms 1 and 2 are complete, the waitlist will receive the Group Problem Management Plus 5 week intervention on its own. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mental health literacy
Measured using a modified depression literacy scale validated in Low- and Middle- Income Countries (LMICs)
Measured: change from baseline at 16 weeks
Attitudes towards mental health help seeking
Measured using the Inventory of Attitudes towards Seeking Mental Health Services
Measured: change from baseline at 16 weeks
Depression
Measured using the PHQ-9
Measured: change from baseline at 16 weeks
Adaptive coping strategies
Measured by the Kidcope and Self-Compassion Scale for Youth
Measured: change from baseline at 16 weeks
Mental Health Stigma
Measured using the Brief Version of the Internalized Stigma of Mental Illness (ISMI) Scale
Measured: change from baseline at 16 weeks
Mental wellbeing
Measured using the WHO-Five Wellbeing Scale
Measured: change from baseline at 16 weeks
Level of functioning
Measured usingWHO Disability Assessment Schedule
Measured: change from baseline at 16 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jan 2022
- Study start31 Jan 2022 (estimated)
- Primary completion27 May 2022 (estimated)
- Study completion27 May 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 Mental HealthStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- 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
- Model description
- The two intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey 8 weeks after the study is complete.
- Masking
- None (open label)
- Enrolment
- 330 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Young African Refugees for Integral Development
- Responsible party
- Principal investigator, Carmen Logie, MSW, PhD, University of Toronto
- Investigators
- Carmen Logie, PhD, Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05187689
- Sponsor's protocol ID
- 40965
- Status last verified
- Jan 2022
- First submitted
- 23 Dec 2021
- Last updated
- 12 Jan 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The final deidentified data set will be available to users who enter a data-sharing agreement with us. Users will need to (1) secure ethics approval from both their institution and the University of Toronto research ethics board; (2) commit to use the data solely for research purposes, and not to identify any individual participant; (3) commit to securing the data using the appropriate computer technology such as encryption; and (4) commit to destroying or returning the data after analyses are complete.
Publications
Logie CH, Okumu M, Kortenaar JL, Gittings L, Khan N, Hakiza R, Kibuuka Musoke D, Nakitende A, Katisi B, Kyambadde P, Khan T, Lester R, Mbuagbaw L. Mobile Health-Supported Virtual Reality and Group Problem Management Plus: Protocol for a Cluster Randomized Trial Among Urban Refugee and Displaced Youth in Kampala, Uganda (Tushirikiane4MH, Supporting Each Other for Mental Health). JMIR Res Protoc. 2022 Dec 8;11(12):e42342. doi: 10.2196/42342.
PubMed 36480274
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tushirikiane4MH: Mental Health Literacy and Mental Health Promotion With Urban Refugee Youth in Kampala, Uganda
- ClinicalTrials.gov ID
- NCT05187689
- Acronym / sponsor ID
- 40965
- Conditions
- Mental Health
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 330 participants (estimated)
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Young African Refugees for Integral Development
- Study start
- 31 Jan 2022 (estimated)
- Primary completion
- 27 May 2022 (estimated)
- Study completion
- 27 May 2022 (estimated)
- First posted
- 12 Jan 2022 (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.
From our previous studies, we know that urban refugee youth commonly report depressive symptoms. The primary aim of this study is to compare the effectiveness of youth-tailored interventions to improve mental health literacy and reduce mental health stigma among urban refugee youth in Kampala, Uganda. There will be two intervention arms and one control arm. The first intervention arm will involve a VR experience that focuses on mental health literacy and coping strategies, as well as SMS check-ins from peer navigators (PN) trained in psychological first aid. The second intervention arm will involve an adapted version of the WHO's Group Problem Management Plus. The primary outcomes are to a) increase mental health literacy (knowledge and understanding of mental health generally and of specific disorders; b) increase attitudes towards mental health help-seeking, c) reduce depression, d) increase adaptive coping strategies; e) reduce mental health stigma, f) improve mental wellbeing, and g) increase level of functioning. Participants will complete a pre- and post-intervention survey as well as a follow-up survey.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- The two intervention arms will be compared to the control arm of the study using a pre- and post-intervention survey. There will also be a follow-up survey 8 weeks after the study is complete.
| Arm | Type | Receives |
|---|---|---|
| Virtual reality and mental health literacy intervention | Experimental | Behavioral: VR + MHL interventionThis arm will participate in an interactive virtual reality experience to learn and practice mental health literacy and psychological first aid skills, supplemented by mhealth SMS with informational bidirectional messages. |
| Group Problem Management+ and VR/mental health literacy | Experimental | Behavioral: Group PM+This arm will participate in an interactive virtual reality experience to learn and practice mental health literacy and psychological first aid skills, supplemented by mhealth SMS with informational bidirectional messages. This arm will also participate in an 5-week Group Problem Management Plus intervention, a group based problem solving intervention. |
| Control | No intervention | –This is a waitlist control. After Arms 1 and 2 are complete, the waitlist will receive the Group Problem Management Plus 5 week intervention on its own. |
Who may qualify
- Ages
- 16 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (6 listed)
- living in one of the 5 informal settlements in Kampala we already work with (Nsambya, Katwe, Rubaga, Kabalagala, Kansanga);
- self identify as a woman or man (transgender inclusive);
- identify as a refugee/displaced person/having refugee parents;
- aged 16-25;
- own a mobile phone;
Key exclusion criteria (1 listed)
- -
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 |
|---|---|---|
| VR + MHL interventionThe intervention will include: 1) a Virtual Reality (VR) interactive and immersive 30-minute session viewed using a low cost VR headset; and 2) an 8-week program of weekly WelTel SMS check-ins managed by Peer Navigators (PNs), weekly WelTel SMS blasts informed by Psychological First Aid (PFA) with mental health literacy (MHL) messages developed with PN, and weekly WelTel web-based secure platform social group discussions on MHL, stress coping, and stigma moderated by PN alongside a trained Coordinator. Weekly MHL WelTel platform moderated discussion foci will address MHL, stigma and stress coping strategies, including self-compassion and other strategies that emerge from the urban refugee youth interviews and focus groups, through diverse methods, including: 'scenarios' mimicking real life situations; a 'question box'; sharing photos demonstrating stress coping strategies; memes; songs; and ways participants interrupted stigma in their daily lives. | Behavioural | Virtual reality and mental health literacy intervention |
| Group PM+Participants will attend small groups (5-6 participants with a PN and a coordinator supporting) outdoors with physically distancing, for Group PM+ sessions following the adapted WHO Group-PM+ manual (adaptations made in Phase 1 explain above) 5 weekly 3-hour sessions delivered by PN who will co-facilitate sessions with the Coordinator. Each session has a mechanism of action: 1. Managing stress: mechanism of action-identify goals, learn deep breathing and techniques for stress management 2. Managing problems: mechanism of action-identify 1 solvable practical problem, brainstorm possible solutions together 3. Get going, keep doing: mechanism of action-learn about depression and inactivity, identify and plan small enjoyable activities 4. Strengthen social support: mechanism of action-discuss a range of social support resources, make plan to increase social support 5. Staying well: mechanism of action- this session reviews all of the mechanisms of action in the prior 4 sessions | Behavioural | Group Problem Management+ and VR/mental health literacy |
Primary outcome
Mental health literacy
Time frame: change from baseline at 16 weeks
Measured using a modified depression literacy scale validated in Low- and Middle- Income Countries (LMICs)
Attitudes towards mental health help seeking
Time frame: change from baseline at 16 weeks
Measured using the Inventory of Attitudes towards Seeking Mental Health Services
Depression
Time frame: change from baseline at 16 weeks
Measured using the PHQ-9
Adaptive coping strategies
Time frame: change from baseline at 16 weeks
Measured by the Kidcope and Self-Compassion Scale for Youth
Mental Health Stigma
Time frame: change from baseline at 16 weeks
Measured using the Brief Version of the Internalized Stigma of Mental Illness (ISMI) Scale
Mental wellbeing
Time frame: change from baseline at 16 weeks
Measured using the WHO-Five Wellbeing Scale
Level of functioning
Time frame: change from baseline at 16 weeks
Measured usingWHO Disability Assessment Schedule
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2022.
- Derived from this study: PubMed 36480274Logie CH, Okumu M, Kortenaar JL, Gittings L, Khan N, Hakiza R, Kibuuka Musoke D, Nakitende A, Katisi B, Kyambadde P, Khan T, Lester R, Mbuagbaw L. Mobile Health-Supported Virtual Reality and Group Problem Management Plus: Protocol for a Cluster Randomized Trial Among Urban Refugee and Displaced Youth in Kampala, Uganda (Tushirikiane4MH, Supporting Each Other for Mental Health). JMIR Res Protoc. 2022 Dec 8;11(12):e42342. doi: 10.2196/42342.
- Individual participant dataSharing planned: Yes. The final deidentified data set will be available to users who enter a data-sharing agreement with us. Users will need to (1) secure ethics approval from both their institution and the University of Toronto research ethics board; (2) commit to use the data solely for research purposes, and not to identify any individual participant; (3) commit to securing the data using the appropriate computer technology such as encryption; and (4) commit to destroying or returning the data after analyses are complete.
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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.
Carmen Logie, PhD principal investigator
University of Toronto
Questions about this trial
What is this clinical trial studying?
A study testing VR + MHL intervention and Group PM+ in people with Mental Health, run by University of Toronto.
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 6 inclusion and 1 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 12 Jan 2022. Status can change between updates, so confirm with the study contact before making plans.
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 Carmen Logie, PhD (6474544203, carmen.logie@utoronto.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mental health literacy (time frame: change from baseline at 16 weeks). The study lists 7 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 NCT05187689, 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 12 Jan 2022.