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

March 12, 2026 updated by: King's College London

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.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

50

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Zimbabwe
      • Harare, Zimbabwe
        • University of Zimbabwe

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 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)).
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)).

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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).
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)
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
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)
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.
From the first treatment session (week 1) to the end of treatment (week 6)
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.
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
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).
At end of Y-MIND intervention sessions or at 5 months post baseline assessment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

King's College London

Collaborators

University of Ghana
Kamuzu University of Health Sciences
University of Zimbabwe

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 28, 2024

Primary Completion (Actual)

August 2, 2025

Study Completion (Estimated)

September 1, 2026

Study Registration Dates

First Submitted

February 27, 2025

First Submitted That Met QC Criteria

February 27, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

March 13, 2026

Last Update Submitted That Met QC Criteria

March 12, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • HR/DP-23/24-44227
  • NIHR133384 (Other Grant/Funding Number: National Institute for Health and Care Research)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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