The Friendship Bench Plus Trial
Key facts
- Where
- Harare, ZimbabweSee the site
Where in Zimbabwe
- University of ZimbabweHarare, ZimbabweTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Bern
- Trial code
- NCT06384209
- Record updated
- 20 November 2025
- Original description
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:Read full original descriptionShow less
Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus 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).
Inclusion: 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.
Exclusion: Patient has received FB in the past 12 months; History of or presenting with serious cardio-vascular disease (including previous heart attack, stroke or arrhythmias); 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 cancer; 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 is currently under treatment (counselling, antidepressants, followed up by a psychiatrist); 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).