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Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

Primary Purpose

Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Severe

Status
Completed
Phase
Not Applicable
Locations
Tanzania
Study Type
Interventional
Intervention
KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)
Sponsored by
Duke University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia Spectrum and Other Psychotic Disorders focused on measuring Family Psychoeducation, Schizophrenia, Tanzania, Severe and Persistent Mental Illness, Culturally tailored

Eligibility Criteria

18 Years - 50 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Muhimbili University of Health and Allied Sciences (MUHAS)
  • Mbeya Zonal Referral Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

KUPAA Intervention + Standard of Care

Control - Standard of Care

Arm 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.

Patients will receive the standard of care.

Outcomes

Primary Outcome Measures

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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
July 8, 2019
Last Updated
January 7, 2022
Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT04013932
Brief Title
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

2. Study Status

Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
August 6, 2019 (Actual)
Primary Completion Date
October 27, 2020 (Actual)
Study Completion Date
October 27, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Duke University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 To pilot test the KUPAA intervention to explore its impact on patient relapse, quality of life and disability Secondary study objectives 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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Severe
Keywords
Family Psychoeducation, Schizophrenia, Tanzania, Severe and Persistent Mental Illness, Culturally tailored

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
Only the main biostatistician will be masked in the study.
Allocation
Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
KUPAA Intervention + Standard of Care
Arm Type
Experimental
Arm 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.
Arm Title
Control - Standard of Care
Arm Type
No Intervention
Arm Description
Patients will receive the standard of care.
Intervention Type
Behavioral
Intervention Name(s)
KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)
Other Intervention Name(s)
FPE, Family psychoeducation
Intervention Description
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.
Primary Outcome Measure Information:
Title
Proportion of Patient Participants Who Experience Illness Relapse
Description
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.
Time Frame
Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)
Title
Change From Baseline to Endline in Disability, as Measured by the World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0)
Description
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.
Time Frame
Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
Title
Change From Baseline to Endline in Quality of Life, as Measured by the World Health Organization Quality of Life- Abbreviated Version (WHOQOL-BREF)
Description
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.
Time Frame
Baseline (pre-intervention) and Endline (~6-7 months post-intervention)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Joy Noel Baumgartner, PhD
Organizational Affiliation
Duke University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Muhimbili University of Health and Allied Sciences (MUHAS)
City
Dar Es Salaam
Country
Tanzania
Facility Name
Mbeya Zonal Referral Hospital
City
Mbeya
Country
Tanzania

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Adhering to NIMH requirements on sharing data through NIMH Data Archive
IPD Sharing Time Frame
By November, 2020
IPD Sharing Access Criteria
NIMH Data Archive
IPD Sharing URL
https://nda.nih.gov/

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Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

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