Friendship Bench Plus — counseling combined with nurse‑prescribed antidepressants
Official title: Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus Trial
Run by University of Bern · NCT06384209 · Data updated 2026-11-12
This trial will test whether adding nurse‑prescribed antidepressants to the Friendship Bench counseling helps adults in Zimbabwe with moderate to severe depression get better than counseling alone.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 296 (estimated) |
| Sponsor | University of Bern Academic / other |
| Locations | 1 site (Harare) |
| Status | Recruiting |
| Started | June 26, 2025 |
| Main results expected | December 28, 2027 |
| Study ends | February 28, 2028 |
| Registry record updated | November 20, 2025 |
| Trial ID | NCT06384209 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Adults aged 18 or older in Zimbabwe with moderate to severe depression (PHQ‑9 ≥11), treatment‑naïve to the Friendship Bench, who speak English or Shona and can give written consent.
✕Probably not a fit
People with mild depression, active psychotic symptoms, high suicide risk, serious medical comorbidities, current pregnancy or intention to become pregnant, or those already receiving specialist mental health treatment are unlikely to receive benefit from this intervention.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized superiority trial in Harare comparing six sessions of the Friendship Bench problem‑solving therapy alone to the same therapy plus nurse‑led antidepressant treatment (fluoxetine, or sertraline for breastfeeding women). Eligible adults (≥18 years) have moderate to severe depression (PHQ‑9 ≥11), speak English or Shona, and have not recently received the Friendship Bench. Participants are randomly assigned to control or intervention arms and followed for clinical outcomes, while the study also collects qualitative data on barriers and enablers to nurse prescription of antidepressants in primary care. The trial is led by the University of Bern in collaboration with the University of Zimbabwe and includes implementation-focused activities to inform scale‑up in local health services.
Why it matters
Potential benefit: If successful, combining counseling with nurse‑prescribed antidepressants could increase recovery rates and make effective depression treatment more widely available in primary care.
How similar studies have gone: The Friendship Bench psychological intervention has shown benefit in prior Zimbabwean trials, but combining it with nurse‑prescribed antidepressants in low‑resource primary care settings has been less well studied.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Criteria: * 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)
Where it's running
-
University of Zimbabwe
Harare, Zimbabwe Recruiting
Study contacts
- Principal investigator: Monika Mueller, MD, PhD — University of Bern
- Study coordinator: Rukudzo Mwamuka, MBCHB, MMED(Psychiatry)
- Email: ruemwamuka.tsungu@gmail.com
- Phone: +263777065549
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.