Friendship Bench Plus — counseling combined with nurse‑prescribed antidepressants

Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus Trial

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

• Phase: NA
• Study type: Interventional
• Enrollment: 296 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: University of Bern (other)
• Locations: 1 site (Harare)
• Trial ID: NCT06384209 on ClinicalTrials.gov

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.

Who should consider this trial

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.

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.

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 performed: 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.

Eligibility 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 this trial is running

Harare

• University of Zimbabwe — Harare, Zimbabwe (RECRUITING)

Study contacts

• Principal investigator: Monika Mueller, MD, PhD — University of Bern
• Study coordinator: Rukudzo Mwamuka, MBCHB, MMED(Psychiatry)

Conditions: Major Depressive Disorder, Severe Depressive Episode Without Psychotic Symptoms, Depression, Depressive disorder, Problem Solving Therapy, Antidepressant, Fluoxetine, Sertraline