Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

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

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.

Study Overview

• Status: Completed
• Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders, Severe
• Intervention / Treatment: Behavioral: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)

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

• Study Type: Interventional
• Enrollment (Actual): 66
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Tanzania
  • Dar Es Salaam, Tanzania
    • Muhimbili University of Health and Allied Sciences (MUHAS)
  • Mbeya, Tanzania
    • Mbeya Zonal Referral Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 48 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Patient Inclusion Criteria:

• Attending outpatient psychiatric services at Muhimbili National Hospital (MNH) or Mbeya Zonal Referral Hospital (MZRH).
• ICD-10 Diagnosis of a non-organic psychotic disorder:
• F20 Schizophrenia
• F21 Schizotypal disorder
• F22 Delusional disorders
• F25 Schizoaffective disorders
• Age 18-50 at the time of informed consent
• Hospitalization or relapse (confirmed by attending psychiatrist or medical officer) within the past 12 months.

Patient Exclusion Criteria:

• F23 Brief psychotic disorder
• F28 Other psychotic disorder not due to a substance or known physiological condition
• F29 Unspecified psychosis not due to a substance or known physiological condition
• Epileptic psychoses
• Bipolar disorder and mania
• Co-morbid developmental disorder, dementia, or other severe cognitive deficit that renders the individual unable to provided informed consent.

Caregiver Inclusion Criteria:

• Age 18 or older at time of consenting process
• Patient agrees that this person can be their paired partner for KUPAA if the pair is randomized to the intervention group

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: KUPAA Intervention + Standard of Care; Patients will be assigned to a KUPAA group composed of approximately 6 patients (joined by their 6 matched caregivers). Patients will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop. Participants will then attend weekly family psychoeducation group sessions (~1.5-2 hours) for 12 weeks.	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.; Other Names: FPE; Family psychoeducation
No Intervention: Control - Standard of Care; Patients will receive the standard of care.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of Patient Participants Who Experience Illness Relapse	Patient relapse measured by hospitalization or non-hospitalized relapse, defined as a new illness episode with recurrence of symptoms after one month of controlled symptoms.	Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)
Change From Baseline to Endline in Disability, as Measured by the World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0)	Scores are measured from the 36-item WHODAS 2.0, the World Health Organization Disability Assessment Schedule, which measures health and disability. WHODAS 2.0 This self-report assessment measures difficulties performing daily activities over the past 30 days. It consists of 36 Likert-formatted questions across six domains: understanding and communicating, getting around, self-care, getting along with others, life activities, and participation in society. WHO's guidelines for the complex scoring method were used to create the total score, ranging from 0 (no disability) to 100 (full disability). Higher scores indicate worse outcomes.	Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
Change From Baseline to Endline in Quality of Life, as Measured by the World Health Organization Quality of Life- Abbreviated Version (WHOQOL-BREF)	Raw total scores are measured from the 26-item WHOQOL-BREF (the abbreviated version of the World Health Organization Quality of Life 100 scale). This self-report assessment has 26 questions across four domains; physical health, psychological, social relationships, and environment. Each item is rated on a five-point Likert scale (1-5) ranging from 1 (not at all, very dissatisfied, very poor) to 5 (an extreme amount, very satisfied, very good); three items needed reverse scoring. The range is 26 (min) to 130 (max) for the total raw score. Higher scores indicate a better outcome.	Baseline (pre-intervention) and Endline (~6-7 months post-intervention)

Collaborators and Investigators

• Sponsor: Duke University
• Collaborators: National Institute of Mental Health (NIMH)
• Investigators: Principal Investigator: Joy Noel Baumgartner, PhD, Duke University

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2019
• Primary Completion (Actual): October 27, 2020
• Study Completion (Actual): October 27, 2020

Study Registration Dates

• First Submitted: July 8, 2019
• First Submitted That Met QC Criteria: July 8, 2019
• First Posted (Actual): July 10, 2019

Study Record Updates

• Last Update Posted (Actual): February 4, 2022
• Last Update Submitted That Met QC Criteria: January 7, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: Schizophrenia; Tanzania; Family Psychoeducation; Severe and Persistent Mental Illness; Culturally tailored
• Additional Relevant MeSH Terms: Pathologic Processes; Schizophrenia; Disease; Psychotic Disorders; Mental Disorders; Schizophrenia Spectrum and Other Psychotic Disorders
• Other Study ID Numbers: Pro00094163; 5R34MH106663 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Plan Description: Adhering to NIMH requirements on sharing data through NIMH Data Archive
• IPD Sharing Time Frame: By November, 2020
• IPD Sharing Access Criteria: NIMH Data Archive
• IPD Sharing Supporting Information Type: Study Protocol; Statistical Analysis Plan (SAP)

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No