Actively Recruiting
The Friendship Bench Plus Trial
Led by University of Bern · Updated on 2025-11-20
296
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
U
University of Bern
Lead Sponsor
U
University of Zimbabwe
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official Title
The Friendship Bench Plus Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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)
AI-Screening
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Trial Site Locations
Total: 1 location
1
University of Zimbabwe
Harare, Zimbabwe
Actively Recruiting
Research Team
R
Rukudzo Mwamuka, MBCHB, MMED(Psychiatry)
CONTACT
M
Monika Mueller, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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