Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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

This study has been completed.
Sponsor:
Collaborators:
U.S. Department of Education
Substance Abuse and Mental Health Services Administration (SAMHSA)
Information provided by:
University of Illinois at Chicago
ClinicalTrials.gov Identifier:
NCT01024569
First received: December 2, 2009
Last updated: NA
Last verified: December 2009
History: No changes posted

December 2, 2009
December 2, 2009
December 2007
September 2009   (final data collection date for primary outcome measure)
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 ]
Same as current
No Changes Posted
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 ]
Same as current
Not Provided
Not Provided
 
Randomized Controlled Trial of Wellness Recovery Action Planning
Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio

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.

Not Provided
Interventional
Phase 1
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
Mental Disorders
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.
  • 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.
    Intervention: Behavioral: Wellness Recovery Action Planning (WRAP)
  • 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
550
October 2009
September 2009   (final data collection date for primary outcome measure)

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
Both
18 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01024569
H133B050003, UIC WRAP Study
Yes
Judith A. Cook, PhD., Principal Investigator, University of Illinois at Chicago
University of Illinois at Chicago
  • U.S. Department of Education
  • Substance Abuse and Mental Health Services Administration (SAMHSA)
Principal Investigator: Judith A. Cook, PhD University of Illinois at Chicago, Department of Psychiatry
University of Illinois at Chicago
December 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP