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

King's College London

Status: Active, not recruiting

Conditions: Depression

Treatments: Behavioral: Y-MIND Intervention

Study type: Interventional

Funder types: Other

Identifiers

NCT06858215

HR/DP-23/24-44227

NIHR133384 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 50 estimated patients

Sex: All

Ages: 15 to 24 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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50 participants in 1 patient group

Y-MIND Intervention

Experimental group

Description:

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)).

Treatment:

Behavioral: Y-MIND Intervention