Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT06858215

African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Young People 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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Notify Me

Key information

Conditions

Depression Behavior Behavioral Symptoms

Age range

15 year–24 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Zimbabwe

Harare, Zimbabwe

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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.

Treatment and study plan

Y-MIND Intervention

Behavioral

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)).

Primary outcomes

  1. 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.

Secondary outcomes

  1. Symptoms of depression

    Time frame: 5 months post baseline assessment

    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.

  2. Acceptability of the intervention

    Time frame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment

    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).

  3. 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)

    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

  4. Fidelity to delivering the psychological intervention

    Time frame: From the first treatment session (week 1) to the end of treatment (week 6)

    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.

  5. Symptoms of anxiety

    Time frame: 5 months post baseline assessment

    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.

  6. Appropriateness of the intervention

    Time frame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment

    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).

Sponsors and collaborators

Lead sponsor

King's College London

Other

Collaborators

  • Kamuzu University of Health Sciences
  • University of Ghana
  • University of Zimbabwe

Registry information

Official study 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

Acronym: Y-MIND

Important dates

Study start
2024
Primary completion
2025
Study completion
2026
First posted
Mar 5, 2025
Registry last updated
Mar 13, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.