An interventional study of Y-MIND Intervention in Depression, sponsored by King's College London. Active, not recruiting at 1 site in Zimbabwe. Open to participants aged 15 Years to 24 Years. Per ClinicalTrials.gov, last updated 2026-03-13.
Sponsored by King's College London · Not applicable, Interventional, and Treatment
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.
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.
8,057 studies on the registry are indexed under Depression; 1,641 are open to participants now.
This study's planned enrollment of 50 is below the median of 84 across 6,720 interventional studies indexed under Depression.
Browse Depression studies →King's College London is the lead sponsor of 506 studies on the registry; 125 are open to participants now.
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Exclusion Criteria:
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)).
Behavioral: Y-MIND Intervention
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)).
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.
Time frame: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
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.
Time frame: 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).
Time frame: 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
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
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.
Time frame: 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.
Time frame: 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).
Time frame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
This study is active, not recruiting, as verified in Mar 2026. You cannot join it, but the record below documents what was studied.
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King's College London