Trial Outcomes & Findings for Family Psychoeducation for Adults With Psychotic Disorders in Tanzania (NCT NCT04013932)
NCT ID: NCT04013932
Last Updated: 2022-02-04
Results Overview
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.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
66 participants
Primary outcome timeframe
Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)
Results posted on
2022-02-04
Participant Flow
At enrollment, all patients had to identify a caregiver for study participation. If the patient was randomized to the intervention arm, the caregiver would participate in the KUPAA groups with the patients. If the patient was randomized to the control arm, there was no interaction with the caregiver beyond standard of care. All data are focused on the patients only for primary outcomes as they are primary unit of analysis.
Participant milestones
| Measure |
KUPAA Intervention + Standard of Care
Patients will be assigned to a KUPAA group composed of approximately 6 patients who will also be joined by their caregivers in their sessions. The patients will first participate in 1-2 joining sessions with a provider, followed by a 1-day group educational workshop open to both the patients and their caregivers. Patient-participants will then attend weekly family psychoeducation group sessions (\~1.5-2 hours) for 12 weeks with their caregiver.
KUPAA Intervention Group (Culturally Tailored 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.
|
Control - Standard of Care
Patients will receive the standard of care.
|
|---|---|---|
|
Overall Study
STARTED
|
33
|
33
|
|
Overall Study
COMPLETED
|
33
|
28
|
|
Overall Study
NOT COMPLETED
|
0
|
5
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Family Psychoeducation for Adults With Psychotic Disorders in Tanzania
Baseline characteristics by cohort
| Measure |
KUPAA Intervention + Standard of Care
n=33 Participants
Patients will be assigned to a KUPAA group composed of approximately 6 patients and 6 matched caregivers. The dyads 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.
KUPAA Intervention Group (Culturally Tailored 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.
|
Control - Standard of Care
n=33 Participants
Patients will receive the standard of care.
|
Total
n=66 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
33.64 years
STANDARD_DEVIATION 8.52 • n=99 Participants
|
32.45 years
STANDARD_DEVIATION 7.94 • n=107 Participants
|
33.05 years
STANDARD_DEVIATION 8.19 • n=206 Participants
|
|
Sex: Female, Male
Female
|
13 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
20 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Tanzania
|
33 Participants
n=99 Participants
|
33 Participants
n=107 Participants
|
66 Participants
n=206 Participants
|
|
4 or more years since illness onset
|
21 Participants
n=99 Participants
|
22 Participants
n=107 Participants
|
43 Participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)Population: Data not collected on two Control participants.
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.
Outcome measures
| Measure |
KUPAA Intervention + Standard of Care
n=33 Participants
Patients will be assigned to a KUPAA group composed of approximately 6 patients (who attend with a matched caregiver). Participants 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.
KUPAA Intervention Group (Culturally Tailored 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.
|
Control - Standard of Care
n=31 Participants
Patients will receive the standard of care.
|
|---|---|---|
|
Proportion of Patient Participants Who Experience Illness Relapse
|
0.27 proportion of participants
Interval 0.13 to 0.46
|
0.45 proportion of participants
Interval 0.27 to 0.64
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)Population: Data not collected on five Control participants.
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.
Outcome measures
| Measure |
KUPAA Intervention + Standard of Care
n=33 Participants
Patients will be assigned to a KUPAA group composed of approximately 6 patients (who attend with a matched caregiver). Participants 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.
KUPAA Intervention Group (Culturally Tailored 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.
|
Control - Standard of Care
n=28 Participants
Patients will receive the standard of care.
|
|---|---|---|
|
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 units on a scale
Standard Deviation 14.66
|
26.67 units on a scale
Standard Deviation 21.58
|
PRIMARY outcome
Timeframe: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)Population: Data not collected on five Control participants.
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.
Outcome measures
| Measure |
KUPAA Intervention + Standard of Care
n=33 Participants
Patients will be assigned to a KUPAA group composed of approximately 6 patients (who attend with a matched caregiver). Participants 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.
KUPAA Intervention Group (Culturally Tailored 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.
|
Control - Standard of Care
n=28 Participants
Patients will receive the standard of care.
|
|---|---|---|
|
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 units on a scale
Standard Deviation 20.98
|
77.39 units on a scale
Standard Deviation 16.95
|
Adverse Events
KUPAA Intervention + Standard of Care
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Control - Standard of Care
Serious events: 2 serious events
Other events: 0 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
KUPAA Intervention + Standard of Care
n=33 participants at risk
Patients will be assigned to a KUPAA group composed of approximately 6 patients per group (with matched caregivers also attending). Patients 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.
KUPAA Intervention Group (Culturally Tailored 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.
|
Control - Standard of Care
n=33 participants at risk
Patients will receive the standard of care.
|
|---|---|---|
|
Psychiatric disorders
Patient who left home temporarily/missing (relapse related)
|
0.00%
0/33 • From baseline to endline data collection (~1 year)
Adverse event data was not collected on caregivers. Death and temporary missing person experiences were identified during follow-up data collection timepoints (review of medical records and contacts with caregivers).
|
6.1%
2/33 • From baseline to endline data collection (~1 year)
Adverse event data was not collected on caregivers. Death and temporary missing person experiences were identified during follow-up data collection timepoints (review of medical records and contacts with caregivers).
|
Other adverse events
Adverse event data not reported
Additional Information
Joy Noel Baumgartner
University of North Carolina at Chapel Hill
Phone: 919.923.8534
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place