DepressionY-MINDNCT06858215
African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Young People With Depression in Zimbabwe
A study testing Y-MIND Intervention in people with Depression, run by King's College London at 1 site in Zimbabwe.
Trial summary
The overarching aim of this single-arm pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by lay counsellors, for the treatment of depression among young people aged 15-24 in in Harare Province, Zimbabwe. Read more about this study
- Who is it for?
- Ages 15 to 24 years
- Conditions the study is for
- Depression
- What is being tested?
- Y-MIND Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteZimbabwe
- Study dates
- 28 Nov 2024to 1 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 15 to 24 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Young people aged 15-24 years
- Scoring 11 or more on the locally validated Patient Health Questionnaire-9 (PHQ-9) for those aged 18+ and 10 or more on the Patient Health Questionnaire Adolescent (PHQ-A) for those < 18 years.
- Willing and able to be followed up for 5 months.
- Willing and able to provide informed consent if aged 18+, or, if aged below 18, willing and able to give informed assent and to approach a caregiver for informed consent procedures
Who cannot join
- Currently receiving any psychological treatment for any common mental disorder through formal health care services
- Active major mental disorder, advanced physical illness which would interfere with their ability to take part in the study or are actively suicidal (assessed through screening using the P4 screener).
- Those with visual and/or hearing impairment; defined as being unable to see and read the intervention manual or hear the interventionist sitting approximately 1 metre away. This will be assessed at informed consent procedures.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Young People Aged 15-24 With Depression in Zimbabwe
The overarching aim of this single-arm pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by lay counsellors, for the treatment of depression among young people aged 15-24 in in Harare Province, Zimbabwe. The study aims to assess the feasibility, acceptability and fidelity of delivering the six-session Y-MIND intervention, and collect preliminary clinical outcomes for depression at 5-month follow up.
Read the detailed description
The overarching aim of this single-arm pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND) for the treatment of depression among young people aged 15-24 in in Harare Province, Zimbabwe. The six session problem solving therapy intervention will be delivered by trained and supervised lay counsellors. 50 young people will be recruited aged 15-24 through primary care clinics to receive the Y Mind intervention. The study aims to assess the feasibility, acceptability and fidelity of delivering the six-session Y-MIND intervention, and collect preliminary clinical outcomes for depression at 5-month follow up.
- Conditions
- Depression
- Being tested
- Y-MIND Intervention
- Keywords
- depression, psychological therapy
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Y-MIND InterventionBehavioural
All participants in the intervention arm will receive the the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised lay counsellors in primary health care clinics. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the counsellor helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)).
| Study group | Role | What they receive |
|---|---|---|
| Y-MIND Intervention | Experimental | All participants in the intervention arm will receive the the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised lay counsellors in primary health care clinics. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the counsellor helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)). Receives: Behavioral: Y-MIND Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of the intervention
Feasibility of the intervention, defined as extent to which the Y Mind intervention can be successfully delivered by interventionists to reduce symptoms of depression in young people, will be measured using the 'Feasibility of Intervention Measure' (FIM) with adolescents who received the Y-MIND intervention.
Measured: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
Secondary outcomes (6)
Symptoms of depression
Symptoms of depression at 5 months post baseline assessment measured using the PHQ-9. The mean PHQ-9 score will be summarised at baseline and 5 month follow up. This will allow for calculation of sample size for a future definitive trial.
Measured: 5 months post baseline assessment
Acceptability of the intervention
Acceptability, defined as the extent to which the programme is perceived to be agreeable and acceptable to treat depression and adolescents, will be measured using the Acceptability of Intervention Measure (AIM) with adolescents at the end of their last intervention session, (or at their 5 month follow up if the intervention session was not attended), and with lay counsellors when they finish delivering the intervention. It will also be explored through semi-structured interviews with young people (at end of 5 months post baseline assessment) and focus group discussions with lay counsellors (after they have finished delivering all intervention sessions).
Measured: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
Feasibility of the intervention (lay counsellors)
Feasibility of the intervention, defined as extent to which the Y Mind intervention can be successfully delivered by interventionists to reduce symptoms of depression in young people will be measured using the Feasibility of Intervention Measure (FIM) (Weiner et al. 2017) with lay counsellors when they finish delivering the intervention and using semi-structured interviews with adolescents and focus group discussions with lay counsellors
Measured: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
Fidelity to delivering the psychological intervention
Fidelity to delivering the psychological intervention, defined as the extent to which the intervention was delivered as intended, and measured by rating 20% of audio-recorded psychological intervention sessions using a culturally adapted form of ENACT called the 'Problem-Solving Therapy Fidelity Scale (PROOF)' tool. Fidelity of receipt of the psychological intervention, defined as the extent to which the intervention is received as intended and measured by recording session attendance.
Measured: From the first treatment session (week 1) to the end of treatment (week 6)
Symptoms of anxiety
Symptoms of anxiety at 5 months post baseline assessment measured using the GAD-7. The mean GAD-7 score will be summarised at baseline and 5 month follow up. This will allow for calculation of sample size for a future definitive trial.
Measured: 5 months post baseline assessment
Appropriateness of the intervention
Appropriateness, defined as the extent to which the programme is perceived as being relevant to treat depression in adolescents, will be measured by using the Intervention Appropriateness Measure (IAM) with adolescents at the end of their last intervention session, (or at their 5 month follow up if the intervention session was not attended) and with guidance and counselling coordinators when they finish delivering the intervention. It will also be explored through semi-structured interviews with young people (at end of 5 months post baseline assessment) and focus group discussions with lay counsellors (after they have finished delivering all intervention sessions).
Measured: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2025
- Study start28 Nov 2024
- Primary completion2 Aug 2025
- Study completion1 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by King's College LondonThe 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- King's College London
- Sponsor type
- University, hospital or other
- Collaborators
- University of Zimbabwe, University of Ghana, Kamuzu University of Health Sciences
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06858215
- Sponsor's protocol ID
- HR/DP-23/24-44227
- Other IDs
- NIHR133384
- Acronym
- Y-MIND
- Status last verified
- Mar 2026
- First submitted
- 27 Feb 2025
- Last updated
- 13 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Young People Aged 15-24 With Depression in Zimbabwe
- ClinicalTrials.gov ID
- NCT06858215
- Acronym / sponsor ID
- Y-MIND / HR/DP-23/24-44227
- Conditions
- Depression
- Keywords
- depression, psychological therapy
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- King's College LondonUniversity, hospital or other
- Collaborators
- University of Zimbabwe, University of Ghana, Kamuzu University of Health Sciences
- Study start
- 28 Nov 2024 (actual)
- Primary completion
- 2 Aug 2025 (actual)
- Study completion
- 1 Sep 2026 (estimated)
- First posted
- 5 Mar 2025 (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 overarching aim of this single-arm pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND), delivered by lay counsellors, for the treatment of depression among young people aged 15-24 in in Harare Province, Zimbabwe. The study aims to assess the feasibility, acceptability and fidelity of delivering the six-session Y-MIND intervention, and collect preliminary clinical outcomes for depression at 5-month follow up.
Detailed description
The overarching aim of this single-arm pilot study is to assess the feasibility of implementing a psychological intervention (Y-MIND) for the treatment of depression among young people aged 15-24 in in Harare Province, Zimbabwe. The six session problem solving therapy intervention will be delivered by trained and supervised lay counsellors. 50 young people will be recruited aged 15-24 through primary care clinics to receive the Y Mind intervention. The study aims to assess the feasibility, acceptability and fidelity of delivering the six-session Y-MIND intervention, and collect preliminary clinical outcomes for depression at 5-month follow up.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Y-MIND Intervention | Experimental | Behavioral: Y-MIND InterventionAll participants in the intervention arm will receive the the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised lay counsellors in primary health care clinics. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the counsellor helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)). |
Who may qualify
- Ages
- 15 to 24 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (4 listed)
- Young people aged 15-24 years
- Scoring 11 or more on the locally validated Patient Health Questionnaire-9 (PHQ-9) for those aged 18+ and 10 or more on the Patient Health Questionnaire Adolescent (PHQ-A) for those < 18 years.
- Willing and able to be followed up for 5 months.
- Willing and able to provide informed consent if aged 18+, or, if aged below 18, willing and able to give informed assent and to approach a caregiver for informed consent procedures
Key exclusion criteria (3 listed)
- Currently receiving any psychological treatment for any common mental disorder through formal health care services
- Active major mental disorder, advanced physical illness which would interfere with their ability to take part in the study or are actively suicidal (assessed through screening using the P4 screener).
- Those with visual and/or hearing impairment; defined as being unable to see and read the intervention manual or hear the interventionist sitting approximately 1 metre away. This will be assessed at informed consent procedures.
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 |
|---|---|---|
| Y-MIND InterventionAll participants in the intervention arm will receive the the Y-Mind intervention. Y-Mind intervention will be delivered by trained and supervised lay counsellors in primary health care clinics. The six sessions will include a) psychoeducation on depression, b) behavioural activation (helping the participant see the connection between their behaviour, daily activities, and low mood and activity scheduling) and c) problem-solving therapy (the counsellor helps the participant identify and define a specific problem to work on, evaluate the potential solutions to the problem, and carry out the selected solution(s)). | Behavioural | Y-MIND Intervention |
Primary outcome
Feasibility of the intervention
Time frame: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
Feasibility of the intervention, defined as extent to which the Y Mind intervention can be successfully delivered by interventionists to reduce symptoms of depression in young people, will be measured using the 'Feasibility of Intervention Measure' (FIM) with adolescents who received the Y-MIND intervention.
6 secondary outcomes
Symptoms of depression
Time frame: 5 months post baseline assessment
Acceptability of the intervention
Time frame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
Feasibility of the intervention (lay counsellors)
Time frame: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
Fidelity to delivering the psychological intervention
Time frame: From the first treatment session (week 1) to the end of treatment (week 6)
Symptoms of anxiety
Time frame: 5 months post baseline assessment
Appropriateness of the intervention
Time frame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2026.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Y-MIND Intervention in people with Depression, run by King's College London at 1 site in Zimbabwe.
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 3 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: under way, not looking for participants, as of the sponsor's last update on 13 Mar 2026. 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 Zimbabwe. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of the intervention (time frame: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 13 Mar 2026; AzTrials last refreshed its copy on 7 Nov 2026.