Mental Disorders
Conditions
Keywords
Severe Mental Illness, Recovery, Psychiatric Disability, Wellness, Peer Service, WRAP
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.
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.
Interventions
BEHAVIORALWellness Recovery Action Planning (WRAP)
WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.
Sponsors
U.S. Department of Education
Substance Abuse and Mental Health Services Administration (SAMHSA)
University of Illinois at Chicago
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
| 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. |
| 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. |
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 251 |
| 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. | 268 |
| Total | 519 |
Baseline characteristics
| Characteristic | Comparison Wait-List Group | Total | Wellness Recovery Action Planning (WRAP) |
|---|---|---|---|
| Age, Continuous | 45.8 years STANDARD_DEVIATION 9.9 | 45.8 years STANDARD_DEVIATION 9.8 | 45.7 years STANDARD_DEVIATION 9.8 |
| Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis Bipolar | 93 Participants | 188 Participants | 95 Participants |
| Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis Depressive | 65 Participants | 125 Participants | 60 Participants |
| Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis Missing | 18 Participants | 25 Participants | 7 Participants |
| Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis Other | 42 Participants | 76 Participants | 34 Participants |
| Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis Schizoaffective | 21 Participants | 47 Participants | 26 Participants |
| Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis Schizophrenia | 29 Participants | 58 Participants | 29 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 9 Participants | 15 Participants | 6 Participants |
| Race (NIH/OMB) Asian | 1 Participants | 3 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 70 Participants | 146 Participants | 76 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 186 Participants | 353 Participants | 167 Participants |
| Region of Enrollment United States | 268 participants | 519 participants | 251 participants |
| Sex: Female, Male Female | 174 Participants | 342 Participants | 168 Participants |
| Sex: Female, Male Male | 94 Participants | 177 Participants | 83 Participants |
| Study Site Canton | 43 Participants | 81 Participants | 38 Participants |
| Study Site Cleveland | 47 Participants | 98 Participants | 51 Participants |
| Study Site Columbus | 55 Participants | 107 Participants | 52 Participants |
| Study Site Dayton | 14 Participants | 26 Participants | 12 Participants |
| Study Site Lorain | 57 Participants | 110 Participants | 53 Participants |
| Study Site Toledo | 52 Participants | 97 Participants | 45 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 4 / 268 | 6 / 251 |
| other Total, other adverse events | 1 / 268 | 1 / 251 |
| serious Total, serious adverse events | 0 / 268 | 0 / 251 |
Outcome results
Primary
Hopefulness
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)
Population: The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Hopefulness | Baseline | 21.67 Score on a Scale | Standard Deviation 4.66 |
| Experimental | Hopefulness | Post-intervention 1 | 22.47 Score on a Scale | Standard Deviation 4.39 |
| Experimental | Hopefulness | Post-intervention 2 | 22.76 Score on a Scale | Standard Deviation 4.68 |
| Control | Hopefulness | Baseline | 21.87 Score on a Scale | Standard Deviation 4.42 |
| Control | Hopefulness | Post-intervention 1 | 22.07 Score on a Scale | Standard Deviation 4.06 |
| Control | Hopefulness | Post-intervention 2 | 22.16 Score on a Scale | Standard Deviation 4.21 |
Comparison: Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.p-value: 0.02Mixed Effects Random Regression
Primary
Patient Self-Advocacy
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)
Population: The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Patient Self-Advocacy | Baseline (Time 1) | 3.47 Score on a Scale | Standard Error 0.5 |
| Experimental | Patient Self-Advocacy | Post-intervention 1 (Time 2) | 3.61 Score on a Scale | Standard Error 0.52 |
| Experimental | Patient Self-Advocacy | Post-intervention 2 (Time 3) | 3.65 Score on a Scale | Standard Error 0.52 |
| Control | Patient Self-Advocacy | Baseline (Time 1) | 3.46 Score on a Scale | Standard Error 0.53 |
| Control | Patient Self-Advocacy | Post-intervention 1 (Time 2) | 3.53 Score on a Scale | Standard Error 0.53 |
| Control | Patient Self-Advocacy | Post-intervention 2 (Time 3) | 3.55 Score on a Scale | Standard Error 0.49 |
p-value: 0.029Mixed Effects Random Regression
Primary
Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)
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)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) | Baseline | 20.6 symptom severity score | Standard Deviation 14.67 |
| Experimental | Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) | Postintervention 1 | 19.52 symptom severity score | Standard Deviation 13.74 |
| Experimental | Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) | Postintervention 2 | 12.20 symptom severity score | Standard Deviation 15.22 |
| Control | Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) | Baseline | 19.29 symptom severity score | Standard Deviation 14.09 |
| Control | Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) | Postintervention 1 | 21.38 symptom severity score | Standard Deviation 13.68 |
| Control | Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI) | Postintervention 2 | 12.65 symptom severity score | Standard Deviation 15 |
p-value: 0.027Mixed Effects Random Regression
Primary
Recovery From Mental Illness
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)
Population: The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Recovery From Mental Illness | Baseline (Time 1) | 88.2 score on a scale | Standard Deviation 14.9 |
| Experimental | Recovery From Mental Illness | Post-intervention 1 (Time 2) | 92.9 score on a scale | Standard Deviation 14.2 |
| Experimental | Recovery From Mental Illness | Post-intervention 2 (Time 3) | 93.7 score on a scale | Standard Deviation 14.7 |
| Control | Recovery From Mental Illness | Baseline (Time 1) | 87.4 score on a scale | Standard Deviation 13.2 |
| Control | Recovery From Mental Illness | Post-intervention 1 (Time 2) | 90.0 score on a scale | Standard Deviation 13.7 |
| Control | Recovery From Mental Illness | Post-intervention 2 (Time 3) | 91.2 score on a scale | Standard Deviation 13.1 |
p-value: 0.042Mixed Effects Random Regression
Secondary
Quality of Life Brief Assessment
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)
Population: The Overall Number of Participants Analyzed reflects the number of participants at Time 1
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Experimental | Quality of Life Brief Assessment | Baseline (Time 1) | 13.1 Score on a Scale | Standard Deviation 2.94 |
| Experimental | Quality of Life Brief Assessment | Post-intervention 1 (Time 2) | 13.7 Score on a Scale | Standard Deviation 2.97 |
| Experimental | Quality of Life Brief Assessment | Post-intervention 2 (Time 3) | 14.1 Score on a Scale | Standard Deviation 2.83 |
| Control | Quality of Life Brief Assessment | Baseline (Time 1) | 13.1 Score on a Scale | Standard Deviation 2.74 |
| Control | Quality of Life Brief Assessment | Post-intervention 1 (Time 2) | 13.5 Score on a Scale | Standard Deviation 2.79 |
| Control | Quality of Life Brief Assessment | Post-intervention 2 (Time 3) | 13.4 Score on a Scale | Standard Deviation 2.97 |
p-value: 0.001Mixed Effects Random Regression