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Completed

NCT Number: NCT01024569

Randomized Controlled Trial of Wellness Recovery Action Planning

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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Key information

Conditions

Mental Disorders

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Illinois at Chicago, Department of Psychiatry

Chicago, Illinois, 60612, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Wellness Recovery Action Planning (WRAP)

Behavioral

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

Primary outcomes

  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 outcomes

  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.

Sponsors and collaborators

Lead sponsor

University of Illinois at Chicago

Other

Collaborators

  • Substance Abuse and Mental Health Services Administration (SAMHSA)
  • U.S. Department of Education

Registry information

Official study title

Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio

Acronym: WRAP RCT

Important dates

Study start
2007
Primary completion
2009
Study completion
2009
First posted
Dec 3, 2009
Registry last updated
Jan 10, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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