NCT04013932

Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

Family Psychoeducation for Adults With Psychotic Disorders in Tanzania (Pilot Clinical Trial of KUPAA)

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 66 (actual)
• Sponsor: Duke University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

The goal of this study is to pilot test a culturally tailored Family Psychoeducation model (KUPAA) for adults with psychotic disorders and their relatives that is appropriate for cultural settings inclusive of both traditional and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the intervention.

Detailed description

Family psychoeducation (FPE) is an evidence-based practice used in high-income countries to help individuals with psychotic disorders and their relatives to cope more effectively with the illness. FPE has never been tested in a low-resource country nor have the mechanisms of action for this psychosocial intervention been fully identified in any context. The goal of this study is to pilot test a culturally tailored Family Psychoeducation model (called KUPAA) for adults with psychotic disorders and their relatives that is appropriate for cultural settings inclusive of both traditional and biomedical ideas about mental illness and that incorporates relatives as co-facilitators of the intervention. Formative research has already been conducted to culturally tailor the model for the Tanzanian context. This pilot study is a small randomized controlled trial (RCT) with 72 patient/relative dyads that will test the KUPAA intervention to a) assess the feasibility and acceptability of the adapted family psychoeducation intervention for 12 weeks, and b) explore its impact on patient relapse, quality of life and disability. Primary study objectives 1. To pilot test the KUPAA intervention to explore its impact on patient relapse, quality of life and disability Secondary study objectives 2. To elucidate the mechanisms of action for KUPAA (e.g. hopefulness, self-efficacy) and refine the mediation and study outcome measures for a future R01/fully powered clinical trial

Conditions

• Schizophrenia Spectrum and Other Psychotic Disorders
• Mental Disorders, Severe

Interventions

Type	Name	Description
BEHAVIORAL	KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)	KUPAA is composed of 3 key components: 1-2 Joining sessions \[\~30 to 45 minutes each\] give the facilitator and participants a chance to get to know each other before KUPAA groups begin and allows time for questions. Educational Workshop is an interactive, one day workshop offering information about biological, psychological and social aspects of mental illness; the nature, effects and side effects of psychiatric treatments; what families can do to help recovery and prevent relapse; and guidelines for managing mental illnesses. 12 Family psychoeducation group sessions \[\~1.5 hours each session\] occur weekly in multi-family groups. These sessions follow an empirically tested format and focus on solving problems that interfere with treatment, illness, and symptoms management and that support coping skills and personal care. Case management may also be provided.

Timeline

• Start date: 2019-08-06
• Primary completion: 2020-10-27
• Completion: 2020-10-27
• First posted: 2019-07-10
• Last updated: 2022-02-04
• Results posted: 2022-02-04

Locations

2 sites across 1 country: Tanzania