Ignite Creation Date:
2024-05-06 @ 8:27 PM
Last Modification Date:
2024-10-26 @ 3:27 PM
Study NCT ID:
NCT06384209
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-04-25
First Post:
2024-04-22
Brief Title:
The Friendship Bench Plus Trial
Sponsor:
University of Bern
Organization:
University of Bern
Study Overview
Official Title:
Combining Antidepressants With Psychological Therapy to Improve Depression Outcome in Zimbabwe - The Friendship Bench Plus Trial
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
FB
Brief 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
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
Detailed Description:
Background and rationale International guidelines including the WHOs 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 200000 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 Zimbabwes 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 11 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-95 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 Zimbabwes Ministry of Healths 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 WHOs 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
Aims and objectives The investigators aim to enhance the Friendship Bench with antidepressants in adults with moderate to severe depression and to inform Zimbabwes 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 11 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-95 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 Zimbabwes Ministry of Healths 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 WHOs 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None