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

NCT06858215 | Active Not Recruiting

• 2 other identifiers: HR/DP-23/24-44227NIHR133384
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

depression; psychological therapy

Outcome Measures

Primary Outcomes (1)

• 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.

  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

  5 months post baseline assessment

• Acceptability of the intervention

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

• Feasibility of the intervention (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

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

• Symptoms of anxiety

  5 months post baseline assessment

Study Arms (1)

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)).

Behavioral: Y-MIND Intervention

Interventions

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)).

Y-MIND Intervention

Eligibility Criteria

• Age: 15 Years - 24 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• King's College London: lead
• University of Zimbabwe: collaborator
• University of Ghana: collaborator
• Kamuzu University of Health Sciences: collaborator

Study Sites (1)

University of Zimbabwe

Harare, Zimbabwe

Location

MeSH Terms

Conditions

Depression

Condition Hierarchy (Ancestors)

Behavioral Symptoms; Behavior

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2025
• First Posted: March 5, 2025
• Study Start: November 28, 2024
• Primary Completion: August 2, 2025
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 13, 2026

Record last verified: 2026-03

Locations

ZI (1)