NCT06384209Recruiting
The Friendship Bench Plus Trial
Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus Trial
Source: ClinicalTrials.gov · Last updated 20 Nov 2025
Brief summary (registry, in English)
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).
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 296 (estimated)
- First submitted
- 22 Apr 2024
- Start date
- 26 Jun 2025
- Primary completion date
- 28 Dec 2027
- Lead sponsor
- University of Bern
- Diseases
- Depression
- NCT number
- NCT06384209
What you commit to
- Study type: Interventional
- Planned participants: 296
- From 26 Jun 2025 to the primary completion date, 28 Dec 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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)
Other illness
- 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
Other
- 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)
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of Zimbabwe Coordinator of this site? Confirm its status | Harare | Zimbabwe | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.