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
  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

Resource links provided by NLM:


Further study details as provided by University of Illinois at Chicago:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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
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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01024569

Locations
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
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 at Chicago:
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 July 22, 2014