The Friendship Bench Plus Trial

NCT06384209 | Recruiting DMC

• 1 other identifier: FBplus2024
• Study Type: interventional
• Target: 296
• Locations: 1 country
• Sites: 1

Brief Summary

The goal of this randomised controlled trial is to enhance the Friendship Bench intervention with antidepressants in adults with moderate to severe depression. The main questions it aims to answer are:

1. 1.Is the combination of the Friendship Bench with nurse-led antidepressants prescribing superior to the Friendship Bench alone?
2. 2.What are the barriers and enablers for the prescription of antidepressants by nurses in primary care?

Conditions

Major Depressive Disorder; Severe Depressive Episode Without Psychotic Symptoms

Keywords

Depression; Depressive disorder; Problem Solving Therapy; Antidepressant; Fluoxetine; Sertraline; Nurse prescribing

Outcome Measures

Primary Outcomes (1)

• Treatment response

  Number of participants with ≥ 50% improvement in the Patient Health Questionnaire 9 (PHQ-9) score as compared to baseline.

  3 months

Secondary Outcomes (1)

• Remission

  3 months

Study Arms (2)

Friendship Bench alone

ACTIVE COMPARATOR

The treatment in the control arm consists of usual care being the Friendship Bench intervention as stand-alone.It consists of six sessions of problem-solving therapy delivered by Lay Health Workers (LHWs) on a bench in a discreet area on the premises of the PHC 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. The LHW help them recognize potentially dysfunctional problem-solving and develop a realistic plan for the successful resolution of the prioritized problem. The sessions will be delivered approximately one week apart.Patients from the control arm will be allowed to cross-over to the intervention arm after the four months follow-up in case of non-response defined as \<50% improvement in PHQ-9 as compared to baseline

Behavioral: Friendship Bench Intervention- Problem Solving Therapy

Friendship Bench Plus Intervention

EXPERIMENTAL

The treatment in the intervention arm combines six sessions of problem-solving therapy for depression delivered by trained LHW and nurse-led prescription of antidepressants. The nurse will begin on the day of the first FB counselling session with 20mg Fluoxetine or 50mg Sertraline if breastfeeding. After two weeks, which corresponds to the third FB counselling session, the nurse will assess for side effects and reinforce adherence. On the sixth treatment session, if patients show \<30% improvement in PHQ-9 as compared to baseline Fluoxetine will be increased to 40mg and Sertraline to 100mg for the duration of the follow-up phase.At three month followup PHQ-9 will be re-administered and non-responders (\< 50% improvement in PHQ9) will be re-evaluated by the nurse to enforce adherence and Fluoxetine will be increased by 20mg and Sertraline by 50mg.

Drug: Fluoxetine; Drug: Sertraline Pill

Interventions

Fluoxetine DRUG

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.If patients show \<30% improvement in PHQ-9 as compared to baseline on the sixth study visit, Fluoxetine will be increased to 40mg, reassured and encouraged that the goals they set can be achieved. At the three months follow-up we will re-administer the PHQ-9 and again calculate treatment response defined as \< 50% improvement (primary outcome). Non-responders will be re-evaluated by the nurse to enforce adherence to the antidepressant medication and Fluoxetine will be increased by 20mg

Friendship Bench Plus Intervention

Sertraline Pill DRUG

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.If patients show \<30% improvement in PHQ-9 as compared to baseline on the sixth study visit, Sertraline will be increased to 100mg, reassured and encouraged that the goals they set can be achieved. At the three months follow-up we will re-administer the PHQ-9 and again calculate treatment response defined as \< 50% improvement (primary outcome). Non-responders will be re-evaluated by the nurse to enforce adherence to the antidepressant medication, and Sertraline will be increased by 50mg

Also known as: Antidepressants-Sertraline, Zoloft

Friendship Bench Plus Intervention

Friendship Bench Intervention- Problem Solving Therapy BEHAVIORAL

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

Friendship Bench alone

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults ≥18 years
• Moderate to severe depression defined as PHQ-9 ≥ 11
• Treatment naïve to the Friendship Bench intervention at the time of recruitment
• Speaks English or Shona (local language)
• Written informed consent

You may not qualify if:

• Mild depression defined as PHQ-9 \<11
• Psychotic symptoms (SSQ-14 probing question 5 positive and confirmation by study coordinator)
• High risk of suicide according to P4 screener
• Patient has received FB in the past 12 months
• Patient is currently under treatment (counselling, antidepressants, followed up by a psychiatrist)
• History of or presenting with end-stage AIDS
• History of or presenting with kidney failure
• History of or presenting with liver failure
• History of or presenting with serious cardio-vascular disease (including previous heart attack, stroke or arrhythmias)
• History of or presenting with cancer
• Positive urine pregnancy test
• Clear intention of pregnancy during the study period
• Not willing to use effective contraception during study period
• Unable to comprehend the nature of the study in either English or Shona (local language)

Sponsors & Collaborators

• University of Bern: lead
• University of Zimbabwe: collaborator
• Swiss National Science Foundation: collaborator

Study Sites (1)

University of Zimbabwe

Harare, Zimbabwe

RECRUITING

MeSH Terms

Conditions

Depressive Disorder, Major; Depression; Depressive Disorder

Interventions

Fluoxetine; Sertraline

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders; Behavioral Symptoms; Behavior

Intervention Hierarchy (Ancestors)

Propylamines; Amines; Organic Chemicals; 1-Naphthylamine; Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Polycyclic Compounds

Study Officials

• Monika Mueller, MD, PhD

  University of Bern

  PRINCIPAL INVESTIGATOR

• Dickson Chibanda, MD, PhD

  University of Zimbabwe

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Rukudzo Mwamuka, MBCHB, MMED(Psychiatry)

CONTACT

+263777065549; ruemwamuka.tsungu@gmail.com

Monika Mueller, PhD

CONTACT

+41798443882; monika.mueller@unibe.ch

Study Design

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

Study Record Dates

• First Submitted: April 22, 2024
• First Posted: April 25, 2024
• Study Start: June 26, 2025
• Primary Completion (Estimated): December 28, 2027
• Study Completion (Estimated): February 28, 2028
• Last Updated: November 20, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available for sharing for at least 10 years after the final data analysis.
• Access Criteria: The Principal Investigators will review requests for data sharing.

Locations

ZI (1)