Randomized Controlled Trial of Wellness Recovery Action Planning (WRAP RCT)
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Purpose
The purpose of this research study is to test the effectiveness of a standardized peer-led intervention to teach self-management skills in improving outcomes of individuals with a severe mental illness. The intervention is known as Wellness Recovery Action Planning or WRAP, co-developed by Dr. Mary Ellen Copeland. The focus of the inquiry is on whether and how developing an individualized plan for successful living: 1) lowers psychiatric symptoms; 2) enhances psychosocial outcomes such as self-perceived recovery, empowerment, self-advocacy, coping, and social support; 3) increases knowledge of personal mental illness self-management strategies; and 4) enhances satisfaction with the service delivery system. The study evaluated the following hypotheses:
Hypothesis #1: Compared to wait-list control subjects, those who participate in the WRAP intervention will report reduced levels of psychiatric symptoms.
Hypothesis #2: Compared to wait-list control subjects, those who participate in the WRAP intervention will report enhanced enhanced feelings of empowerment, hope, recovery, quality of life, and functioning.
Hypothesis #3: Compared to wait-list controls, those who participate in the WRAP intervention will report increased levels of social support.
Hypothesis #4: Compared to wait-list controls, those who participate in the WRAP intervention will report increased use of peer services, higher satisfaction with services, and have lower overall service costs.
Hypothesis #5: Compared to controls, those who participate in the WRAP intervention will report increased knowledge of mental illness self-management, including making/using a WRAP plan.
Hypothesis #6: There will be no difference in employment rates of control vs. intervention subjects.
| Condition | Intervention | Phase |
|---|---|---|
|
Mental Disorders |
Behavioral: Wellness Recovery Action Planning (WRAP) |
Phase 1 Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
| Official Title: | Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio |
- Psychiatric Symptoms Recovery using the Brief Symptoms Inventory (BSI) [ Time Frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry) ] [ Designated as safety issue: No ]
- Personal Empowerment, measured using the Boston University Empowerment Scale (Rogers et al.) [ Time Frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry) ] [ Designated as safety issue: No ]
| Enrollment: | 550 |
| Study Start Date: | December 2007 |
| Study Completion Date: | October 2009 |
| Primary Completion Date: | September 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: Wellness Recovery Action Planning (WRAP)
WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks. Topics include: Introduction to WRAP, Developing a Wellness Toolbox, Creating a Daily Maintenance Plan, Identifying Triggers, Identifying Early Warning Signs, Managing When Things Break Down, and Crisis Planning. Coursework is interactive, using lecture, question and answer, group discussion, and individual or group exercises. Each session includes a lecture on recovery topics such as self-esteem, changing negative thoughts to positive ones, peer support, and lifestyle issues.
|
Behavioral: Wellness Recovery Action Planning (WRAP)
WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.
|
|
No Intervention: Comparison Wait-List Group
Participants assigned to the comparison group were in a delayed treatment condition in which they continued in public services as usual, but were offered the chance to attend WRAP groups after their final research interview.
|
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria
- age 18 years or older
- English speaking
- severe mental illness as confirmed by: 1) a Kessler Self-Report Measure (K-6) score of 13 or higher; and/or 2) enrolled as a client of the public mental health system in the state of Ohio.
Exclusion Criteria
- non English speaking
- not meeting clinical criteria for severe mental illness
Contacts and Locations| United States, Illinois | |
| University of Illinois at Chicago, Department of Psychiatry | |
| Chicago, Illinois, United States, 60612 | |
| Principal Investigator: | Judith A. Cook, PhD | University of Illinois at Chicago, Department of Psychiatry |
More Information
Additional Information:
Publications:
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Judith A. Cook, PhD., Principal Investigator, University of Illinois at Chicago |
| ClinicalTrials.gov Identifier: | NCT01024569 History of Changes |
| Other Study ID Numbers: | H133B050003, UIC WRAP Study |
| Study First Received: | December 2, 2009 |
| Last Updated: | December 2, 2009 |
| Health Authority: | United States: Federal Government |
Keywords provided by University of Illinois:
|
Severe Mental Illness Recovery Psychiatric Disability |
Wellness Peer Service WRAP |
Additional relevant MeSH terms:
|
Mental Disorders Psychotic Disorders Schizophrenia and Disorders with Psychotic Features |
ClinicalTrials.gov processed this record on June 17, 2013