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The Friendship Bench Plus Trial

RecruitingNAAges 18 Years - anyAllUniversity of Bern
NCT06384209 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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).

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📋 Eligibility rules (as published)
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)
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What it tests

  • Fluoxetine
  • Sertraline Pill
  • Friendship Bench Intervention- Problem Solving Therapy
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Where

1 site
University of Zimbabwe
Harare, Zimbabwe
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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