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Randomized Controlled Trial of Wellness Recovery Action Planning (WRAP RCT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01024569
Recruitment Status : Completed
First Posted : December 3, 2009
Results First Posted : January 10, 2020
Last Update Posted : January 10, 2020
Sponsor:
Collaborators:
U.S. Department of Education
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by (Responsible Party):
Judith A. Cook, University of Illinois at Chicago

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.


Condition or disease Intervention/treatment Phase
Mental Disorders Behavioral: Wellness Recovery Action Planning (WRAP) Not Applicable

Detailed Description:
Eligibility criteria included having a diagnosis of serious mental illness and experiencing severe functional impairment in one or more life roles. All study participants completed telephone interviews at three points in time: study entry (pre-intervention); 8-weeks later (immediate post-intervention); and 6-months after intervention (approximately 8 months after study entry). Blinded interviewers administered valid and reliable outcome assessments that measured changes in subjects' knowledge about mental illness; emotional well-being; empowerment; hopefulness; quality of life, and functioning. All study participants were compensated for their time at each interview. All WRAP facilitators were people in recovery from serious mental illnesses who were certified and experienced WRAP facilitators. Fidelity to the WRAP curriculum was assessed on an ongoing basis throughout the study.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 555 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Health Services Research
Official Title: Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio
Study Start Date : December 2007
Actual Primary Completion Date : September 2009
Actual Study Completion Date : October 2009

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mental Disorders

Arm Intervention/treatment
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.



Primary Outcome Measures :
  1. 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) ]
    The BSI is a patient self-report mental health symptoms research instrument (Piersma et al., 1994). Respondents are asked how much they were bothered in the past week by 53 symptoms on 9 dimensions with a 5-point response scale ranging from ''not at all'' to ''extremely.'' We assessed the BSI Positive Symptom Score which captures the number of symptoms endorsed in a pathological direction, representing the total volume of different symptoms reported to be present to any degree. The minimum value is 0 and the maximum score is 212, where higher scores mean a worse outcome.

  2. Hopefulness [ Time Frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry) ]
    Hopefulness is measured by the State Hope Scale. Hopefulness as a cross-situational long-term trait is assessed via patient self-report using a 12-item scale assessed on a 4-point Likert response scale with options ranging from "definitely false" to "definitely true" and summed to produce a total score and sub-scale scores. The minimum value for this scale is 12 and the maximum value is 48. Higher scores indicate a better income.

  3. Patient Self-Advocacy [ Time Frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry) ]
    The ability to advocate for oneself with medical care providers is assessed via self-report using The Patient Self-Advocacy Scale, an 18-item scale with a 5-point Likert response set ranging from "strongly disagree" to "strongly agree". Dimensions include in patient knowledge, assertiveness, and potential for mindful non-adherence to treatment. Values range from a minimum of 18 to a maximum of 90, with higher scores indicating a better outcome.

  4. Recovery From Mental Illness [ Time Frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry) ]
    This outcome is measured by the Recovery Assessment Scale (RAS). Recovery is a psychosocial outcome assessed via patient self-ratings on a 41-item scale using a 5-point Likert-Response format ranging from "strongly disagree" to "strongly agree". The minimum value for the RAS is 41 and the maximum is 205, with higher scores indicating a better outcome. Dimensions of recovery include personal confidence and hope, willingness to ask for help, goal and success orientation, reliance on others, and not being dominated by one's residual psychiatric symptoms.


Secondary Outcome Measures :
  1. Quality of Life Brief Assessment [ Time Frame: Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry) ]
    Quality of Life was assessed by the World Health Organization Quality of Life Brief Assessment (WHOQOL-BREF). The 8-item environment sub-scale was utilized for our study. Respondents rate their experience of 8 quality indicators over the past 2 weeks using a 5-point Likert response scale. The minimum value is 8 and the maximum is 40, with higher scores meaning better outcomes.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01024569


Locations
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United States, Illinois
University of Illinois at Chicago, Department of Psychiatry
Chicago, Illinois, United States, 60612
Sponsors and Collaborators
University of Illinois at Chicago
U.S. Department of Education
Substance Abuse and Mental Health Services Administration (SAMHSA)
Investigators
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Principal Investigator: Judith A. Cook, PhD University of Illinois at Chicago, Department of Psychiatry
Additional Information:
Publications of Results:

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Responsible Party: Judith A. Cook, Professor of Psychiatry, University of Illinois at Chicago
ClinicalTrials.gov Identifier: NCT01024569    
Other Study ID Numbers: 2006-0103
UIC WRAP Study ( Other Grant/Funding Number: H133B050003 )
First Posted: December 3, 2009    Key Record Dates
Results First Posted: January 10, 2020
Last Update Posted: January 10, 2020
Last Verified: December 2019
Keywords provided by Judith A. Cook, University of Illinois at Chicago:
Severe Mental Illness
Recovery
Psychiatric Disability
Wellness
Peer Service
WRAP
Additional relevant MeSH terms:
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Mental Disorders