Clinical trial NCT04013932: Family Psychoeducation for Adults With Psychotic Disorders in Tanzania
Official title: Family Psychoeducation for Adults With Psychotic Disorders in Tanzania (Pilot Clinical Trial of KUPAA)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders
Mental Disorders, Severe
Keywords: Family Psychoeducation
Schizophrenia
Tanzania
Severe and Persistent Mental Illness
Culturally tailored
Lead sponsor: Duke University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2019-07-10
Enrollment: 66
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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

Eligibility 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

Primary outcomes:
measure: Proportion of Patient Participants Who Experience Illness Relapse
timeFrame: Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)
measure: Change From Baseline to Endline in Disability, as Measured by the World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0)
timeFrame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
measure: Change From Baseline to Endline in Quality of Life, as Measured by the World Health Organization Quality of Life- Abbreviated Version (WHOQOL-BREF)
timeFrame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
Secondary outcomes:
Other outcomes:
Locations:
city: Dar Es Salaam
country: Tanzania
facility: Muhimbili University of Health and Allied Sciences (MUHAS)
city: Mbeya
country: Tanzania
facility: Mbeya Zonal Referral Hospital
Study officials:
affiliation: Duke University
name: Joy Noel Baumgartner, PhD
role: PRINCIPAL_INVESTIGATOR
References: