The Friendship Bench Plus Trial

NAActive, not recruitingINTERVENTIONAL
Enrollment

296

Participants

Timeline

Start Date

June 26, 2025

Primary Completion Date

December 28, 2027

Study Completion Date

February 28, 2028

Conditions
Major Depressive DisorderSevere Depressive Episode Without Psychotic Symptoms
Interventions
DRUG

Fluoxetine

The treatment in the intervention arm consists of the Friendship Bench Plus Intervention (FB+) which combines six sessions of problem-solving therapy for depression delivered by trained Lay Health Workers and nurse-led prescription of antidepressants. The nurse will begin on the day of the first FB counselling session with 20mg Fluoxetine. The nurse will then dispense the antidepressants for two weeks. As the study population comprises patients with more severe forms of depression, the investigators don't expect a relevant response to this starting dose. Therefore, after two weeks, which corresponds to the third FB counselling session, the nurse will increase to 40mg Fluoxetine.If patients show \<30% improvement in PHQ-9 as compared to baseline on the sixth study visit, Fluoxetine will be increased to 60mg, reassured and encouraged that the goals they set can be achieved.

DRUG

Sertraline Pill

The treatment in the intervention arm consists of the Friendship Bench Plus Intervention (FB+) which combines six sessions of problem-solving therapy for depression delivered by trained Lay Health Workers and nurse-led prescription of antidepressants. The nurse will begin on the day of the first FB counselling session with 50mg Sertraline for all breastfeeding women instead of Fluoxetine. The nurse will then dispense the antidepressants for two weeks. As the study population comprises patients with more severe forms of depression, the investigators don't expect a relevant response to this starting dose. Therefore, after two weeks, which corresponds to the third FB counselling session, the nurse will increase to 100mg Sertraline if breastfeeding.If patients show \<30% improvement in PHQ-9 as compared to baseline on the sixth study visit, Sertraline will be increased to 150mg.

BEHAVIORAL

Friendship Bench Intervention- Problem Solving Therapy

The Friendship Bench Problem-solving therapy is an evidence-based intervention for depression delivered by Lay Health Workers according to an established manual. Patients are encouraged to come up with a list of their problems, to select one problem they want to tackle, brainstorm for solutions, identify the best solution, and develop an action plan to implement it until the next session. Each session consists of four stages, namely kuvhura pfungwa (opening the mind), kusimudzira (uplifting), kusimbisa (strengthening) and kusimbisisa (re-strengthening). The LHW helps patients to recognize potentially dysfunctional problem-solving and develop a realistic plan for the successful resolution of the prioritized problem. Participants are reassured and encouraged that the goals they set can be achieved. The sessions will be delivered approximately one week apart

Trial Locations (1)

Unknown

University of Zimbabwe, Harare

All Listed Sponsors
collaborator

University of Zimbabwe

OTHER

collaborator

Swiss National Science Foundation

OTHER

lead

University of Bern

OTHER

NCT06384209 - The Friendship Bench Plus Trial | Biotech Hunter | Biotech Hunter