Mental Disorders, Severe, Schizophrenia Spectrum and Other Psychotic Disorders
Conditions
Keywords
Family Psychoeducation, Schizophrenia, Tanzania, Severe and Persistent Mental Illness, Culturally tailored
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 1. To pilot test the KUPAA intervention to explore its impact on patient relapse, quality of life and disability Secondary study objectives 2. 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
Interventions
BEHAVIORALKUPAA 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.
Sponsors
National Institute of Mental Health (NIMH)
Duke University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Masking description
Only the main biostatistician will be masked in the study.
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
Inclusion 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Proportion of Patient Participants Who Experience Illness Relapse | 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) | 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) | 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. |
Countries
Tanzania
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| KUPAA Intervention + Standard of Care 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. | 33 |
| Control - Standard of Care Patients will receive the standard of care. | 33 |
| Total | 66 |
Baseline characteristics
| Characteristic | KUPAA Intervention + Standard of Care | Control - Standard of Care | Total |
|---|---|---|---|
| 4 or more years since illness onset | 21 Participants | 22 Participants | 43 Participants |
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical Between 18 and 65 years | 33 Participants | 33 Participants | 66 Participants |
| Age, Continuous | 33.64 years STANDARD_DEVIATION 8.52 | 32.45 years STANDARD_DEVIATION 7.94 | 33.05 years STANDARD_DEVIATION 8.19 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 33 Participants | 33 Participants | 66 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Tanzania | 33 Participants | 33 Participants | 66 Participants |
| Sex: Female, Male Female | 13 Participants | 9 Participants | 22 Participants |
| Sex: Female, Male Male | 20 Participants | 24 Participants | 44 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 33 | 1 / 33 |
| other Total, other adverse events | 0 / 33 | 0 / 33 |
| serious Total, serious adverse events | 0 / 33 | 2 / 33 |
Outcome results
Primary
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.
Time frame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
Population: Data not collected on five Control participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KUPAA Intervention + 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 |
| Control - 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) | 26.67 units on a scale | Standard Deviation 21.58 |
Primary
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.
Time frame: Baseline (pre-intervention) and Endline (~6-7 months post-intervention)
Population: Data not collected on five Control participants.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| KUPAA Intervention + 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 |
| Control - 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) | 77.39 units on a scale | Standard Deviation 16.95 |
Primary
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.
Time frame: Relapse is measured from immediate post-intervention to endline (~6-7 months post-intervention)
Population: Data not collected on two Control participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| KUPAA Intervention + Standard of Care | Proportion of Patient Participants Who Experience Illness Relapse | 0.27 proportion of participants |
| Control - Standard of Care | Proportion of Patient Participants Who Experience Illness Relapse | 0.45 proportion of participants |