WRAP RCT: Randomized Controlled Trial of Wellness Recovery Action Planning

• Sponsor: University of Illinois at Chicago (Other)
• Overall Status: Completed
• CT.gov ID: NCT01024569
• Collaborator: U.S. Department of Education (U.S. Fed), Substance Abuse and Mental Health Services Administration (SAMHSA) (U.S. Fed)
• Enrollment: 555
• Location: 1
• Arms: 2
• Duration (Months): 22
• Patients Per Site Per Month: 25.2

Study Details

Study Description

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)	N/A

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.

Study Design

• Study Type: Interventional
• 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: Dec 1, 2007
• Actual Primary Completion Date: Sep 1, 2009
• Actual Study Completion Date: Oct 1, 2009

Arms and Interventions

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.

Outcome Measures

Primary Outcome Measures

1. Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) [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 [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 [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 [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 [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Locations

	Site	City	State	Country	Postal Code
1	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

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• University of Illinois at Chicago National Research & Training Center

Publications

None provided.

• 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
• First Posted: Dec 3, 2009
• Last Update Posted: Jan 10, 2020
• Last Verified: Dec 1, 2019

• Keywords provided by Judith A. Cook, Professor of Psychiatry, University of Illinois at Chicago: Severe Mental Illness; Recovery; Psychiatric Disability; Wellness; Peer Service; WRAP
• Additional relevant MeSH terms: Mental Disorders

Study Results

Participant Flow

Arm/Group Title	Wellness Recovery Action Planning (WRAP)	Comparison Wait-List Group
Arm/Group Description	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. 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.	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.
Period Title: Overall Study
STARTED	276	279
COMPLETED	251	268
NOT COMPLETED	25	11

Baseline Characteristics

Arm/Group Title	Wellness Recovery Action Planning (WRAP)	Comparison Wait-List Group	Total
Arm/Group Description	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. 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.	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.	Total of all reporting groups
Overall Participants	251	268	519
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	45.7 (9.8)	45.8 (9.9)	45.8 (9.8)
Sex: Female, Male (Count of Participants)
Female	168 66.9%	174 64.9%	342 65.9%
Male	83 33.1%	94 35.1%	177 34.1%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	6 2.4%	9 3.4%	15 2.9%
Asian	2 0.8%	1 0.4%	3 0.6%
Native Hawaiian or Other Pacific Islander	0 0%	0 0%	0 0%
Black or African American	76 30.3%	70 26.1%	146 28.1%
White	167 66.5%	186 69.4%	353 68%
More than one race	0 0%	2 0.7%	2 0.4%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (participants) [Number]
United States	251 100%	268 100%	519 100%
Study Site (Count of Participants)
Canton	38 15.1%	43 16%	81 15.6%
Cleveland	51 20.3%	47 17.5%	98 18.9%
Columbus	52 20.7%	55 20.5%	107 20.6%
Dayton	12 4.8%	14 5.2%	26 5%
Lorain	53 21.1%	57 21.3%	110 21.2%
Toledo	45 17.9%	52 19.4%	97 18.7%
Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis (Count of Participants)
Schizophrenia	29 11.6%	29 10.8%	58 11.2%
Schizoaffective	26 10.4%	21 7.8%	47 9.1%
Bipolar	95 37.8%	93 34.7%	188 36.2%
Depressive	60 23.9%	65 24.3%	125 24.1%
Other	34 13.5%	42 15.7%	76 14.6%
Missing	7 2.8%	18 6.7%	25 4.8%

Outcome Measures

1. Primary Outcome

Title	Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)
Description	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.
Time Frame	Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Outcome Measure Data

Analysis Population Description

[Not Specified]

Arm/Group Title	Experimental	Control
Arm/Group Description	Received intervention	Did not receive intervention
Measure Participants	251	268
Baseline	20.6 (14.67)	19.29 (14.09)
Postintervention 1	19.52 (13.74)	21.38 (13.68)
Postintervention 2	12.20 (15.22)	12.65 (15.00)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.027
	Comments
	Method	Mixed Effects Random Regression
	Comments
Method of Estimation	Estimation Parameter	MIXREG Estimate
	Estimated Value	-1.16
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: -2.21
	Estimation Comments

2. Primary Outcome

Title	Hopefulness
Description	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.
Time Frame	Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Outcome Measure Data

Analysis Population Description

The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.

Arm/Group Title	Wellness Recovery Action Planning (WRAP)	Comparison Wait-List Group
Arm/Group Description	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. 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.	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.
Measure Participants	248	264
Baseline	21.67 (4.66)	21.87 (4.42)
Post-intervention 1	22.47 (4.39)	22.07 (4.06)
Post-intervention 2	22.76 (4.68)	22.16 (4.21)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments	Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.020
	Comments
	Method	Mixed Effects Random Regression
	Comments
Method of Estimation	Estimation Parameter	MIXREG Estimate
	Estimated Value	0.40
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 2.37
	Estimation Comments

3. Primary Outcome

Title	Patient Self-Advocacy
Description	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.
Time Frame	Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Outcome Measure Data

Analysis Population Description

The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline

Arm/Group Title	Experimental	Control
Arm/Group Description	Received intervention	Did not receive intervention
Measure Participants	251	268
Baseline (Time 1)	3.47 (0.50)	3.46 (0.53)
Post-intervention 1 (Time 2)	3.61 (0.52)	3.53 (0.53)
Post-intervention 2 (Time 3)	3.65 (0.52)	3.55 (0.49)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.029
	Comments
	Method	Mixed Effects Random Regression
	Comments
Method of Estimation	Estimation Parameter	MIXREG Estimate
	Estimated Value	0.05
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.02
	Estimation Comments

4. Primary Outcome

Title	Recovery From Mental Illness
Description	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.
Time Frame	Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Outcome Measure Data

Analysis Population Description

The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.

Arm/Group Title	Experimental	Control
Arm/Group Description	Received intervention	Did not receive intervention
Measure Participants	248	265
Baseline (Time 1)	88.2 (14.9)	87.4 (13.2)
Post-intervention 1 (Time 2)	92.9 (14.2)	90.0 (13.7)
Post-intervention 2 (Time 3)	93.7 (14.7)	91.2 (13.1)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	0.042
	Comments
	Method	Mixed Effects Random Regression
	Comments
Method of Estimation	Estimation Parameter	MIXREG Estimate
	Estimated Value	1.06
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.52
	Estimation Comments

5. Secondary Outcome

Title	Quality of Life Brief Assessment
Description	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.
Time Frame	Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)

Outcome Measure Data

Analysis Population Description

The Overall Number of Participants Analyzed reflects the number of participants at Time 1

Arm/Group Title	Experimental	Control
Arm/Group Description	Received intervention	Did not receive intervention
Measure Participants	251	268
Baseline (Time 1)	13.1 (2.94)	13.1 (2.74)
Post-intervention 1 (Time 2)	13.7 (2.97)	13.5 (2.79)
Post-intervention 2 (Time 3)	14.1 (2.83)	13.4 (2.97)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Experimental, Control
	Comments
	Type of Statistical Test	Superiority
	Comments
Statistical Test of Hypothesis	p-Value	.001
	Comments
	Method	Mixed Effects Random Regression
	Comments
Method of Estimation	Estimation Parameter	MIXREG Estimate
	Estimated Value	0.39
	Confidence Interval	(2-Sided) %; to
	Parameter Dispersion	Type: Standard Error of the Mean; Value: 0.11
	Estimation Comments

Adverse Events

Time Frame	3 years
Arm/Group Title	Wellness Recovery Action Planning (WRAP)		Comparison Wait-List Group
Arm/Group Description	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. 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.		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.
All Cause Mortality
	Wellness Recovery Action Planning (WRAP)		Comparison Wait-List Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	4/268 (1.5%)		6/251 (2.4%)
Serious Adverse Events
	Wellness Recovery Action Planning (WRAP)		Comparison Wait-List Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/268 (0%)		0/251 (0%)
Other (Not Including Serious) Adverse Events
	Wellness Recovery Action Planning (WRAP)		Comparison Wait-List Group
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/268 (0.4%)		1/251 (0.4%)
Psychiatric disorders
Psychiatric Disorders	1/268 (0.4%)	1	0/251 (0%)	0
Psychiatric Disorders	0/268 (0%)	0	1/251 (0.4%)	1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.