Actively Recruiting
Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus Trial
Led by University of Bern · Updated on 2025-11-20
296
Participants Needed
1
Research Sites
8 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
Researchers are evaluating the effect of combining the Friendship Bench intervention with nurse-led antidepressant prescribing in adults with moderate to severe depression. This randomized controlled superiority trial aims to determine if adding antidepressants to the Friendship Bench therapy improves treatment response compared to the Friendship Bench alone. The study also explores barriers and enablers to nurse-led antidepressant prescription in primary care settings in Zimbabwe, addressing the high burden of depression and limited specialist care in low-income countries. Participants will be randomly assigned to one of two groups. The control group will receive six weekly sessions of the Friendship Bench Problem Solving Therapy delivered by lay health workers. The intervention group will receive the same Friendship Bench therapy plus antidepressants prescribed by nurses—Fluoxetine for most participants and Sertraline for breastfeeding women. Dosages may be adjusted based on symptom improvement during treatment visits and follow-up at three months. After three months, patients with insufficient improvement may have their antidepressant dose increased. Participants will be followed for three months to assess treatment response using the PHQ-9 depression scale. Additional follow-up at six months will be open-label. Researchers will conduct interviews and focus groups to understand factors affecting nurse-led antidepressant prescribing. Safety monitoring and adherence support are included. After the study, patients will be referred to specialist care for continued treatment. The trial aims to inform mental health care scale-up in Zimbabwe and contribute to international guidelines.
CONDITIONS
Brief Title
The Friendship Bench Plus Trial
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults 18 years or older
- Moderate to severe depression defined as PHQ-9 score of 11 or higher
- Treatment naïve to the Friendship Bench intervention at recruitment
- Able to speak English or Shona (local language)
- Provided written informed consent
You will not qualify if you...
- Mild depression defined as PHQ-9 score below 11
- Presence of psychotic symptoms confirmed by screening
- High risk of suicide based on P4 screener
- Received Friendship Bench intervention in past 12 months
- Currently receiving treatment for depression (counseling, antidepressants, or psychiatric follow-up)
- History or current condition of end-stage AIDS
- History or current kidney failure
- History or current liver failure
- History or current serious cardiovascular disease including heart attack, stroke, or arrhythmias
- History or current cancer
- Positive urine pregnancy test
- Intention to become pregnant during the study period
- Unwillingness to use effective contraception during the study period
- Unable to understand the study in English or Shona (local language)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants receive six sessions of problem-solving therapy delivered by Lay Health Workers approximately one week apart. Participants in the intervention arm also receive nurse-led prescription of antidepressants starting on the first counselling session, with medication adjustments based on symptom improvement and adherence.
Six weekly visits for therapy sessions and medication management
Duration - Up to 3 months post-treatment
At 3 months, participants are evaluated for treatment response and non-responders receive further nurse evaluation and possible medication dosage increase. After this, participants are referred for continued specialist care outside the study.
1 visit for outcome assessment and possible re-evaluation
Trial Site Locations
Total: 1 location
1
University of Zimbabwe
Harare, Zimbabwe
Actively Recruiting
Research Team
R
Rukudzo Mwamuka, MBCHB, MMED(Psychiatry)
M
Monika Mueller, PhD
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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