Randomized Controlled Trial of Wellness Recovery Action Planning

NCT ID: NCT01024569

Last Updated: 2020-01-10

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

555 participants

Study Classification

INTERVENTIONAL

Study Start Date

2007-12-31

Study Completion Date

2009-10-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Mental Disorders

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

HEALTH_SERVICES_RESEARCH

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type EXPERIMENTAL

Wellness Recovery Action Planning (WRAP)

Intervention Type BEHAVIORAL

WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

U.S. Department of Education

FED

Sponsor Role collaborator

Substance Abuse and Mental Health Services Administration (SAMHSA)

FED

Sponsor Role collaborator

University of Illinois at Chicago

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Judith A. Cook

Professor of Psychiatry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Judith A. Cook, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Illinois at Chicago, Department of Psychiatry

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

University of Illinois at Chicago, Department of Psychiatry

Chicago, Illinois, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

References

Explore related publications, articles, or registry entries linked to this study.

Cook JA, Copeland ME, Jonikas JA, Hamilton MM, Razzano LA, Grey DD, Floyd CB, Hudson WB, Macfarlane RT, Carter TM, Boyd S. Results of a randomized controlled trial of mental illness self-management using Wellness Recovery Action Planning. Schizophr Bull. 2012 Jun;38(4):881-91. doi: 10.1093/schbul/sbr012. Epub 2011 Mar 14.

Reference Type RESULT
PMID: 21402724 (View on PubMed)

Cook JA, Copeland ME, Floyd CB, Jonikas JA, Hamilton MM, Razzano L, Carter TM, Hudson WB, Grey DD, Boyd S. A randomized controlled trial of effects of Wellness Recovery Action Planning on depression, anxiety, and recovery. Psychiatr Serv. 2012 Jun;63(6):541-7. doi: 10.1176/appi.ps.201100125.

Reference Type RESULT
PMID: 22508435 (View on PubMed)

Jonikas JA, Grey DD, Copeland ME, Razzano LA, Hamilton MM, Floyd CB, Hudson WB, Cook JA. Improving propensity for patient self-advocacy through wellness recovery action planning: results of a randomized controlled trial. Community Ment Health J. 2013 Jun;49(3):260-9. doi: 10.1007/s10597-011-9475-9. Epub 2011 Dec 14.

Reference Type RESULT
PMID: 22167660 (View on PubMed)

Snyder CR, Sympson SC, Ybasco FC, Borders TF, Babyak MA, Higgins RL. Development and validation of the State Hope Scale. J Pers Soc Psychol. 1996 Feb;70(2):321-35. doi: 10.1037//0022-3514.70.2.321.

Reference Type RESULT
PMID: 8636885 (View on PubMed)

Scanlan JN, Hancock N, Honey A. The Recovery Assessment Scale - Domains and Stages (RAS-DS): Sensitivity to change over time and convergent validity with level of unmet need. Psychiatry Res. 2018 Mar;261:560-564. doi: 10.1016/j.psychres.2018.01.042.

Reference Type RESULT
PMID: 29407723 (View on PubMed)

Brashers DE, Haas SM, Neidig JL. The patient self-advocacy scale: measuring patient involvement in health care decision-making interactions. Health Commun. 1999;11(2):97-121. doi: 10.1207/s15327027hc1102_1.

Reference Type RESULT
PMID: 16370972 (View on PubMed)

Skevington SM, Lotfy M, O'Connell KA; WHOQOL Group. The World Health Organization's WHOQOL-BREF quality of life assessment: psychometric properties and results of the international field trial. A report from the WHOQOL group. Qual Life Res. 2004 Mar;13(2):299-310. doi: 10.1023/B:QURE.0000018486.91360.00.

Reference Type RESULT
PMID: 15085902 (View on PubMed)

Related Links

Access external resources that provide additional context or updates about the study.

http://www.cmhsrp.uic.edu/nrtc/

University of Illinois at Chicago National Research \& Training Center

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

UIC WRAP Study

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

2006-0103

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Working Toward Wellness
NCT00694681 COMPLETED NA
Wellness Self-Management
NCT01676909 COMPLETED NA
Student Wellness 2.0
NCT06804213 COMPLETED NA
Intern Health Study 2025
NCT07052357 ENROLLING_BY_INVITATION NA
Groups for Regaining Our Wellbeing
NCT03058952 COMPLETED NA