Randomized Controlled Trial of Wellness Recovery Action Planning (WRAP RCT)
| Tracking Information | |||||
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| First Received Date ICMJE | December 2, 2009 | ||||
| Last Updated Date | December 2, 2009 | ||||
| Start Date ICMJE | December 2007 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
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 ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | No Changes Posted | ||||
| Current Secondary Outcome Measures ICMJE |
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 ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | Randomized Controlled Trial of Wellness Recovery Action Planning | ||||
| Official Title ICMJE | Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio | ||||
| Brief Summary | 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. |
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| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Interventional | ||||
| Study Phase | Phase 1 Phase 2 |
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| Study Design ICMJE | Allocation: Randomized Intervention Model: Parallel Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Health Services Research |
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| Condition ICMJE | Mental Disorders | ||||
| Intervention ICMJE | 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. |
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| Publications * |
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 550 | ||||
| Completion Date | October 2009 | ||||
| Primary Completion Date | September 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria
Exclusion Criteria
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| Gender | Both | ||||
| Ages | 18 Years and older | ||||
| Accepts Healthy Volunteers | No | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT01024569 | ||||
| Other Study ID Numbers ICMJE | H133B050003, UIC WRAP Study | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Judith A. Cook, PhD., Principal Investigator, University of Illinois at Chicago | ||||
| Study Sponsor ICMJE | University of Illinois | ||||
| Collaborators ICMJE |
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| Investigators ICMJE |
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| Information Provided By | University of Illinois | ||||
| Verification Date | December 2009 | ||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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