Clinical trial NCT06858215: African Youth in Mind (Y-MIND) - Pilot Feasibility Trial of a Brief Psychological Intervention for Young People with Depression in Zimbabwe
Official 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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Depression
Keywords: depression
psychological therapy
Lead sponsor: King's College London
Sponsor class: OTHER
Collaborators: name: University of Zimbabwe
name: University of Ghana
name: Kamuzu University of Health Sciences
First posted: 2025-03-05
Enrollment: 50
Sex: ALL
Minimum age (years): 15
Maximum age (years): 24
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Feasibility of the intervention
timeFrame: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
Secondary outcomes:
measure: Symptoms of depression
timeFrame: 5 months post baseline assessment
measure: Acceptability of the intervention
timeFrame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
measure: Feasibility of the intervention (lay counsellors)
timeFrame: At the end of treatment (week 6) (or at their 5 months post baseline assessment if the treatment sessions were not attended)
measure: Fidelity to delivering the psychological intervention
timeFrame: From the first treatment session (week 1) to the end of treatment (week 6)
measure: Symptoms of anxiety
timeFrame: 5 months post baseline assessment
measure: Appropriateness of the intervention
timeFrame: At end of Y-MIND intervention sessions or at 5 months post baseline assessment
Other outcomes:
Locations:
city: Harare
country: Zimbabwe
facility: University of Zimbabwe
Study officials:
References: