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The Friendship Bench Plus Trial

StatusRecruiting
PhaseNot applicable
Started
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Record History

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  1. Trial status: Active, Not Recruiting to Recruiting
    • Eligibility criteria expanded, about 42 words
    • Study description revised
    • Site details revised
    v5
  2. Trial status: Not Yet Recruiting to Active, Not Recruiting
    • Start date changed from estimate of Jun 1, 2025 to Jun 26, 2025
    • Site contact updated
    • Study title shortened, about 4 words
    v4
  3. Study description shortened, about 2 words
    • Study title expanded, about 4 words
    v3
  4. Primary completion date: Dec 28, 2026 to Dec 28, 2027v2 Show 6 more changesShow less
    • Start date: Jul 1, 2024 to Jun 1, 2025
    • Study completion date: Feb 28, 2027 to Feb 28, 2028
    • Interventions: Antidepressants -Fluoxetine (Drug), Friendship Bench intervention (Behavioral) to Fluoxetine (Drug), Friendship Bench Intervention- Problem Solving Therapy (Behavioral), Sertraline Pill (Drug)
    • Eligibility criteria expanded, about 23 words
    • Secondary endpoints: details revised at 1 of 1 entry
    • Study description expanded, about 268 words
  5. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
University of Bern
73 trials monitored
See 3 trials at risk
Depression
3,055 trials monitored
See 173 trials at risk
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).
Trial Details
NCT Number NCT06384209
Lead Sponsor University of Bern
Collaborators: University of Zimbabwe, Swiss National Science Foundation
Conditions
(from sponsor)		 Major Depressive Disorder, Severe Depressive Episode Without Psychotic Symptoms
Related terms Depression, Depressive Disorder, Major Depressive Disorder
Enrollment 296 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov