Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

NCT04013932 | Completed Results

• 2 other identifiers: Pro000941635R34MH106663
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 2

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.

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders, Severe

Keywords

Family Psychoeducation; Schizophrenia; Tanzania; Severe and Persistent Mental Illness; Culturally tailored

Outcome Measures

Primary Outcomes (3)

• 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)

Study Arms (2)

KUPAA Intervention + Standard of Care

EXPERIMENTAL

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)

Control - Standard of Care

NO INTERVENTION

Patients will receive the standard of care.

Interventions

KUPAA Intervention Group (Culturally Tailored Family Psychoeducation) BEHAVIORAL

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.

Also known as: FPE, Family psychoeducation

KUPAA Intervention + Standard of Care

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• Duke University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Muhimbili University of Health and Allied Sciences (MUHAS)

Dar es Salaam, Tanzania

Location

Mbeya Zonal Referral Hospital

Mbeya, Tanzania

Location

Related Publications (2)

• Egger JR, Kaaya S, Swai P, Lawala P, Ndelwa L, Temu J, Bukuku ES, Lukens E, Susser E, Dixon L, Minja A, Clari R, Martinez A, Headley J, Baumgartner JN. Functioning and quality of life among treatment-engaged adults with psychotic disorders in urban Tanzania: Baseline results from the KUPAA clinical trial. PLoS One. 2024 Jun 18;19(6):e0304367. doi: 10.1371/journal.pone.0304367. eCollection 2024.

  PMID: 38889160 DERIVED

• Martinez A, Baumgartner JN, Kaaya S, Swai P, Lawala PS, Thedai B, Minja A, Headley J, Egger JR. Hopefulness among individuals living with schizophrenia and their caregivers in Tanzania: an actor-partner interdependence model. BMC Psychiatry. 2023 Jul 13;23(1):508. doi: 10.1186/s12888-023-04990-8.

  PMID: 37442999 DERIVED

MeSH Terms

Conditions

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders; Schizophrenia

Results Point of Contact

• Title: Joy Noel Baumgartner
• Organization: University of North Carolina at Chapel Hill

joy.baumgartner@unc.edu

919.923.8534

Study Officials

• Joy Noel Baumgartner, PhD

  Duke University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Only the main biostatistician will be masked in the study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 8, 2019
• First Posted: July 10, 2019
• Study Start: August 6, 2019
• Primary Completion: October 27, 2020
• Study Completion: October 27, 2020
• Last Updated: February 4, 2022
• Results First Posted: February 4, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: By November, 2020
• Access Criteria: NIMH Data Archive

Locations

TA (2)