The Friendship Bench Plus Trial

Major Depressive Disorder Clinical Trial

— FB+  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06384209
• Other study ID #: FBplus2024
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2024
• Est. completion date: February 28, 2027

Study information

• Verified date: April 2024
• Source: University of Bern
• Contact: Rukudzo Mwamuka, MBCHB, MMED(Psychiatry)
• Phone: +263777065549
• Email: ruemwamuka.tsungu[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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 non-specialists 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).

Description:

Background and rationale: International guidelines, including the WHO's mental health gap guidelines for treatment of mental disorders in primary care, propose antidepressants for patients with moderate to severe depression alongside psychological interventions. Despite these clear recommendations, there is a scarcity of trials on the effect of antidepressants in low-income countries such as Zimbabwe. Even though every fourth primary care attendee has depression up to 90% of them go untreated, in part due to scarcity of mental health care services. To relieve limited specialist care and yet respond to the high burden of disease, treatment of depression needs to be integrated into primary care and delivered by non-specialists. The Friendship Bench in Zimbabwe uses a brief psychological intervention that is delivered by lay health workers (LHW) in primary care. It has been implemented in 200 primary health centres, with over 200'000 patients having accessed treatment since 2016. During this scale-up only 40% of the patients showed good response. This warrants further development of the Friendship Bench with special attention to patients with moderate to severe depression. Aims and objectives: The investigators aim to enhance the Friendship Bench with antidepressants in adults with moderate to severe depression and to inform Zimbabwe's Ministry of Health on the scale-up of nurse-led prescription of antidepressants in primary care. The primary objective is to evaluate the effect of the Friendship Bench Plus antidepressants on treatment response after 4 months as compared to usual care being the Friendship Bench stand-alone. The investigators hypothesise that the Friendship Bench Plus, which combines six sessions of problem-solving therapy delivered by LHW and nurse-led prescription of antidepressants is superior to Friendship Bench stand-alone consisting of six sessions of problem-solving therapy. The secondary objective is to identify barriers and enablers for the prescription of antidepressants by non-specialists in primary care. Methods: To achieve the primary objective the investigators will conduct an individual randomized controlled superiority trial with 1:1 allocation to intervention and control arm based on stratified and blocked randomisation. A 4-month follow-up and an extended open label follow-up at 6 months will be conducted. A total of 296 adults with moderate to severe depression (PHQ-9 ≥11) will be recruited from 12 primary health care centres in Harare, Zimbabwe. The patients in the Friendship Bench Plus arm will receive Fluoxetine (Sertraline for breastfeeding women) prescribed by general nurses. The primary outcome will be treatment response (≥ 50% improvement in the PHQ-9 at 4 months) and the key secondary outcome will be remission (PHQ-9<5 at 4 months). An intention-to-treat analyses using mixed-effects logistic regression adjusted for baseline PHQ-9 and gender as fixed effects, and recruitment site as random effect will be performed. To achieve the secondary objective, the investigators will conduct three qualitative pilot studies to identify barriers and enablers for the prescription of antidepressants by general nurses in primary care. In-depth, face to face interviews with adults presenting with moderate to severe depression in primary care who meet the eligibility criteria for the trial, focus group discussions with general nurses and LHW as delivery agents of the FB+ intervention and a Delphi stakeholder meeting with experts from academia, primary care, the Friendship Bench, general nurses and LHW as the interventionists, the Ministry of Health of Zimbabwe, the WHO and service users in Zimbabwe will be conducted. Expected Results: The investigators aim to contribute to guideline development through development of a treatment manual on how to use antidepressants in primary care through nurse led-prescription that will inform the Ministry of Health of Zimbabwe on its scale-up. The study outcomes will be presented at international conferences and publish all related articles open access in high-ranking specialist journals. The study aligns with Zimbabwe's Ministry of Health's effort to scale up the provision of mental health care through primary health care. The study is also attentive to international mental health policy as depression is a priority condition covered by the WHO and Zimbabwe is one of the WHO's target countries through its Special Initiative for mental health. Contextualising nurse-led prescription of antidepressants into the current scale-up of the Friendship Bench and the relevant capacity building component of the investigators' research will translate to improved patient care beyond the lifecycle of the study.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 296
• Est. completion date: February 28, 2027
• Est. primary completion date: December 28, 2026
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Adults =18 years
• Moderate to severe depression defined as PHQ-9 = 11 6
• Treatment naïve to the Friendship Bench intervention at the time of recruitment
• Written informed consent

Exclusion Criteria:

• Mild depression defined as PHQ-9 <11
• Receiving specialist mental health care including antidepressants at the time of recruitment
• Pregnancy (urine pregnancy test will be performed)
• History of serious physical health problem (kidney failure, liver failure, serious heart disease, cancer, end-stage AIDS)
• Presenting with high suicidal risk
• Presenting with psychotic symptoms
• Unable to comprehend the nature of the study in either English or Shona (local language)

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

Behavioral:
• Friendship Bench intervention
Trained Lay Health Workers (LHWs) deliver six weekly sessions of the Problem Solving Therapy on a bench in a discreet area on the premises of the PHC. Each session consists of four stages, namely opening the mind, uplifting, strengthening and re-strengthening. Opening up the mind includes psychoeducation and normalizing depression as a mental health condition. The aim of uplifting is to identify and formulate the problems that could contribute to depressed mood. Patients categorize and rate each problem in terms of its importance and potential solvability and brainstorm lists of possible solutions. In the next stage, strengthening, clients are encouraged to consider the pros and cons of potential solutions. The LHW helps them recognize potentially dysfunctional problem-solving and develop a realistic plan to resolve the prioritized problem. In the final stage, further strengthening, participants are reassured and encouraged that the goals they set can be achieved.

Drug:
• Antidepressants -Fluoxetine
If randomised to the intervention arm, participants will be prescribed the first dose of Fluoxetine 20mg or Sertraline 50mg if breastfeeding. They will receive weekly Friendship Bench sessions as in the control arm. The antidepressants will be tapered on the third study visit to Fluoxetine 40mg or Sertraline 100mg.The next tapering will be done on the sixth study visit. The general nurse will be informed on the treatment response and increase Fluoxetine to 60mg and Sertraline to 150mg in patients of the intervention arm without partial response defined as <30% improvement in PHQ-9 as compared to baseline.

Locations

Country	Name	City	State
Zimbabwe	University of Zimbabwe	Harare

Sponsors (3)

Lead Sponsor	Collaborator
University of Bern	Swiss National Science Foundation, University of Zimbabwe

Country where clinical trial is conducted

Zimbabwe, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Treatment response	Number of participants with = 50% improvement in the PHQ-9 score as compared to baseline.	4 months
Secondary	Remission	Number of participants with remission defined as PHQ-9<5 at 4 months.	4 months