Schizophrenia Spectrum and Other Psychotic DisordersNCT04013932

Family Psychoeducation for Adults With Psychotic Disorders in Tanzania

A study testing KUPAA Intervention Group (Culturally Tailored Family Psychoeducation) in people with Schizophrenia Spectrum and Other Psychotic Disorders and Mental Disorders, Severe, run by Duke University at 2 sites in Tanzania.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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… Read more about this study

Who is it for?: Ages 18 to 50 years
Conditions the study is for: Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Severe
What is being tested?: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)
Type of treatment: Lifestyle or therapy programme
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 66 participants
Where: 2 sitesTanzania
Study dates: 6 Aug 2019to 27 Oct 2020
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 50 years
All sexes
No healthy volunteers
Adult

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

Trial locations and contacts

2 sites in 1 country.

Tanzania2 sites

Muhimbili University of Health and Allied Sciences (MUHAS)
Dar es Salaam
Mbeya Zonal Referral Hospital
Mbeya

Other trials in Tanzania

About this study

Official title: Family Psychoeducation for Adults With Psychotic Disorders in Tanzania (Pilot Clinical Trial of KUPAA)

Read the 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

Conditions: Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Severe
Being tested: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)
Keywords: Family Psychoeducation, Schizophrenia, Tanzania, Severe and Persistent Mental Illness, Culturally tailored
Medical subject headings: Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Schizophrenia

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)Behavioural
Also called FPE, Family psychoeducation
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.

Study groups in NCT04013932
Study group	Role	What they receive
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. Receives: Behavioral: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)
Control - Standard of Care	No intervention	Patients will receive the standard of care.

What is being measured

The primary outcome is the main question the study is designed to answer.

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

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

6 Aug 201927 Oct 2020

First posted10 Jul 2019
Study start6 Aug 2019
Primary completion27 Oct 2020
Study completion27 Oct 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Schizophrenia Spectrum and Other Psychotic DisordersStudies of the same condition, open and under way.
More trials run by Duke UniversityThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 66 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04013932
Sponsor's protocol ID: Pro00094163
Other IDs: 5R34MH106663
Status last verified: Jan 2022
First submitted: 8 Jul 2019
Last updated: 4 Feb 2022
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: Yes: Adhering to NIMH requirements on sharing data through NIMH Data Archive

Publications

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.
PubMed 38889160
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.
PubMed 37442999

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 4 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Family Psychoeducation for Adults With Psychotic Disorders in Tanzania (Pilot Clinical Trial of KUPAA)
ClinicalTrials.gov ID: NCT04013932
Acronym / sponsor ID: Pro00094163
Conditions: Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders, Severe
Keywords: Family Psychoeducation, Schizophrenia, Tanzania, Severe and Persistent Mental Illness, Culturally tailored
Study type: Interventional
Recruitment status: Completed
Enrolment: 66 participants (actual)
Lead sponsor: Duke UniversityUniversity, hospital or other
Collaborators: National Institute of Mental Health (NIMH)
Study start: 6 Aug 2019 (actual)
Primary completion: 27 Oct 2020 (actual)
Study completion: 27 Oct 2020 (actual)
First posted: 10 Jul 2019 (actual)
Results: Posted 4 Feb 2022

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

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

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
KUPAA Intervention + Standard of Care	Experimental	Behavioral: KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)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.
Control - Standard of Care	No intervention	–Patients will receive the standard of care.

Who may qualify

Ages: 18 to 50 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
KUPAA Intervention Group (Culturally Tailored Family Psychoeducation)Also: FPE, Family psychoeducationKUPAA 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.	Behavioural	KUPAA Intervention + Standard of Care

Primary outcome

Proportion of Patient Participants Who Experience Illness Relapse
Time frame: Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)
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)
Time frame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
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)
Time frame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
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.

Results and safety

Results posted to the registry on 4 Feb 2022, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
KUPAA Intervention + Standard of Care	33	33
Control - Standard of Care	33	28

Primary outcome: Proportion of Patient Participants Who Experience Illness Relapse

Time frame: Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention). Number (95% Confidence Interval). Unit: proportion of participants

Measure	KUPAA Intervention + Standard of Care n = 33	Control - Standard of Care n = 31
Value	0.27 (0.13 to 0.46)	0.45 (0.27 to 0.64)

Population analysed: Data not collected on two Control participants.

Primary outcome: Change From Baseline to Endline in Disability, as Measured by the World Health Organization Disability Assessment Schedule Version 2.0 (WHODAS 2.0)

Time frame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention). Mean (Standard Deviation). Unit: units on a scale

Measure	KUPAA Intervention + Standard of Care n = 33	Control - Standard of Care n = 28
Value	14.89 (14.66)	26.67 (21.58)

Population analysed: Data not collected on five Control participants.

Primary outcome: Change From Baseline to Endline in Quality of Life, as Measured by the World Health Organization Quality of Life- Abbreviated Version (WHOQOL-BREF)

Time frame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention). Mean (Standard Deviation). Unit: units on a scale

Measure	KUPAA Intervention + Standard of Care n = 33	Control - Standard of Care n = 28
Value	94.88 (20.98)	77.39 (16.95)

Population analysed: Data not collected on five Control participants.

Adverse events

Time frame: From baseline to endline data collection (~1 year). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
KUPAA Intervention + Standard of Care	0 of 33 (0%)	0 of 33 (0%)	0 of 33
Control - Standard of Care	2 of 33 (6.1%)	0 of 33 (0%)	1 of 33

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2022.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 38889160Egger 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.
Derived from this study: PubMed 37442999Martinez 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.
Individual participant dataSharing planned: Yes. Adhering to NIMH requirements on sharing data through NIMH Data Archive

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Joy Noel Baumgartner, PhD principal investigator

Duke University

2 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 4 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Tanzania. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 4 Feb 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Proportion of Patient Participants Who Experience Illness Relapse (time frame: Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04013932, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2022.