The Friendship Bench Plus Trial
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Bern
About this trial
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).
Eligibility criteria
Qualifiers
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)
Disqualifiers
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
Trial design
Treatments tested in this trial
- Fluoxetine
- Sertraline Pill
- Friendship Bench Intervention- Problem Solving Therapy
Treatment groups
296 Participants
are divided into 2 treatment groupsSponsors and collaborators
University of Bern
Lead sponsor
University of Zimbabwe
Collaborator
Swiss National Science Foundation
Collaborator
Source ClinicalTrials.gov