The Friendship Bench Plus Trial

ConditionsMajor Depressive Disorder Severe Depressive Episode Without Psychotic Symptoms

Trial statusRecruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18+

SponsorUniversity of Bern

About this trial

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

Type of study: Randomized controlled superiority trial

Participants will be randomly selected and allocated into the control arm or intervention arm. Participants in the control arm will receive six sessions of the Friendship Bench Problem Solving Therapy while those in the intervention arm will receive the Friendship Bench intervention plus Fluoxetine (Sertraline for breastfeeding women).

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

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
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
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

Treatment groups

296 Participants

are divided into 2 treatment groups

Group A: Friendship Bench aloneActive comparator 1 intervention

Group B: Friendship Bench Plus InterventionExperimental treatment 2 interventions

Trial outcomes

Primary outcomes

Treatment response

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

Time frame

3 months

Secondary outcomes

Remission

Number of participants with remission defined as Patient Health Questionnaire 9 (PHQ-9\<5)at 3 months.

Time frame

3 months

Sponsors and contacts

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University of Bern

Lead sponsor

University of Zimbabwe

Collaborator

Swiss National Science Foundation