Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

Duke University

Status: Completed

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders, Severe

Treatments: Behavioral: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT04013932

5R34MH106663 (U.S. NIH Grant/Contract)

Pro00094163

Details and patient eligibility

About

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.

Full 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

Enrollment: 66 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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66 participants in 2 patient groups

KUPAA Intervention + Standard of Care

Experimental group

Description:

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.

Treatment:

Behavioral: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)

Control - Standard of Care

No Intervention group

Description:

Patients will receive the standard of care.