CompletedNot Applicable

Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

Tanzania66 participantsStarted 2019-08-06

Plain-language 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.

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Proportion of Patient Participants Who Experience Illness Relapse

Timeframe: 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)

Timeframe: 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)

Timeframe: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)

Trial details

NCT IDNCT04013932

SponsorDuke University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2020-10-27

Results submitted2021-11-17

View on ClinicalTrials.gov More Schizophrenia Spectrum and Other Psychotic Disorders trials

Plain-language summary

Who can participate

Age range

18 Years – 50 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Proportion of Patient Participants Who Experience Illness Relapse

Timeframe: 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)

Timeframe: 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)

Timeframe: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)