N/A
Completed N=66
Family Psychoeducation for Adults With Psychotic Disorders in Tanzania
Schizophrenia Spectrum and Other Psychotic Disorders · Mental Disorders, Severe
Source: ClinicalTrials.gov NCT04013932 ↗
Enrolled (actual)
66
Serious AEs
3.0%
Results posted
Feb 2022
Primary outcomePrimary: Proportion of Patient Participants Who Experience Illness Relapse — 0.27; 0.45 proportion of participants
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Proportion of Patient Participants Who Experience Illness Relapse |
0.27; 0.45 | — |
| PRIMARY Change From Baseline to Endline in Disability, as Measured by the World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0) |
14.89; 26.67 | — |
| PRIMARY Change From Baseline to Endline in Quality of Life, as Measured by the World Health Organization Quality of Life- Abbreviated Version (WHOQOL-BREF) |
94.88; 77.39 | — |
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
Data sourced from ClinicalTrials.gov (NCT04013932). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.