Trial Outcomes & Findings for Randomized Controlled Trial of Wellness Recovery Action Planning (NCT NCT01024569)
NCT ID: NCT01024569
Last Updated: 2020-01-10
Results Overview
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.
COMPLETED
NA
555 participants
Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)
2020-01-10
Participant Flow
Participant milestones
| Measure |
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.
|
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.
|
|---|---|---|
|
Overall Study
STARTED
|
276
|
279
|
|
Overall Study
COMPLETED
|
251
|
268
|
|
Overall Study
NOT COMPLETED
|
25
|
11
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Randomized Controlled Trial of Wellness Recovery Action Planning
Baseline characteristics by cohort
| Measure |
Wellness Recovery Action Planning (WRAP)
n=251 Participants
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.
|
Comparison Wait-List Group
n=268 Participants
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
n=519 Participants
Total of all reporting groups
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|---|---|---|---|
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Age, Continuous
|
45.7 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
45.8 years
STANDARD_DEVIATION 9.9 • n=7 Participants
|
45.8 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
168 Participants
n=5 Participants
|
174 Participants
n=7 Participants
|
342 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
83 Participants
n=5 Participants
|
94 Participants
n=7 Participants
|
177 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
6 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
76 Participants
n=5 Participants
|
70 Participants
n=7 Participants
|
146 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
167 Participants
n=5 Participants
|
186 Participants
n=7 Participants
|
353 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
251 participants
n=5 Participants
|
268 participants
n=7 Participants
|
519 participants
n=5 Participants
|
|
Study Site
Canton
|
38 Participants
n=5 Participants
|
43 Participants
n=7 Participants
|
81 Participants
n=5 Participants
|
|
Study Site
Cleveland
|
51 Participants
n=5 Participants
|
47 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Study Site
Columbus
|
52 Participants
n=5 Participants
|
55 Participants
n=7 Participants
|
107 Participants
n=5 Participants
|
|
Study Site
Dayton
|
12 Participants
n=5 Participants
|
14 Participants
n=7 Participants
|
26 Participants
n=5 Participants
|
|
Study Site
Lorain
|
53 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
110 Participants
n=5 Participants
|
|
Study Site
Toledo
|
45 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
97 Participants
n=5 Participants
|
|
Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis
Schizophrenia
|
29 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
58 Participants
n=5 Participants
|
|
Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis
Schizoaffective
|
26 Participants
n=5 Participants
|
21 Participants
n=7 Participants
|
47 Participants
n=5 Participants
|
|
Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis
Bipolar
|
95 Participants
n=5 Participants
|
93 Participants
n=7 Participants
|
188 Participants
n=5 Participants
|
|
Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis
Depressive
|
60 Participants
n=5 Participants
|
65 Participants
n=7 Participants
|
125 Participants
n=5 Participants
|
|
Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis
Other
|
34 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
76 Participants
n=5 Participants
|
|
Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis
Missing
|
7 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 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.
Outcome measures
| Measure |
Experimental
n=251 Participants
Received intervention
|
Control
n=268 Participants
Did not receive intervention
|
|---|---|---|
|
Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)
Baseline
|
20.6 symptom severity score
Standard Deviation 14.67
|
19.29 symptom severity score
Standard Deviation 14.09
|
|
Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)
Postintervention 1
|
19.52 symptom severity score
Standard Deviation 13.74
|
21.38 symptom severity score
Standard Deviation 13.68
|
|
Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)
Postintervention 2
|
12.20 symptom severity score
Standard Deviation 15.22
|
12.65 symptom severity score
Standard Deviation 15.00
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Experimental
n=248 Participants
Received intervention
|
Control
n=264 Participants
Did not receive intervention
|
|---|---|---|
|
Hopefulness
Baseline
|
21.67 Score on a Scale
Standard Deviation 4.66
|
21.87 Score on a Scale
Standard Deviation 4.42
|
|
Hopefulness
Post-intervention 1
|
22.47 Score on a Scale
Standard Deviation 4.39
|
22.07 Score on a Scale
Standard Deviation 4.06
|
|
Hopefulness
Post-intervention 2
|
22.76 Score on a Scale
Standard Deviation 4.68
|
22.16 Score on a Scale
Standard Deviation 4.21
|
PRIMARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Experimental
n=251 Participants
Received intervention
|
Control
n=268 Participants
Did not receive intervention
|
|---|---|---|
|
Patient Self-Advocacy
Baseline (Time 1)
|
3.47 Score on a Scale
Standard Error 0.50
|
3.46 Score on a Scale
Standard Error 0.53
|
|
Patient Self-Advocacy
Post-intervention 1 (Time 2)
|
3.61 Score on a Scale
Standard Error 0.52
|
3.53 Score on a Scale
Standard Error 0.53
|
|
Patient Self-Advocacy
Post-intervention 2 (Time 3)
|
3.65 Score on a Scale
Standard Error 0.52
|
3.55 Score on a Scale
Standard Error 0.49
|
PRIMARY outcome
Timeframe: 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.
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.
Outcome measures
| Measure |
Experimental
n=248 Participants
Received intervention
|
Control
n=265 Participants
Did not receive intervention
|
|---|---|---|
|
Recovery From Mental Illness
Baseline (Time 1)
|
88.2 score on a scale
Standard Deviation 14.9
|
87.4 score on a scale
Standard Deviation 13.2
|
|
Recovery From Mental Illness
Post-intervention 1 (Time 2)
|
92.9 score on a scale
Standard Deviation 14.2
|
90.0 score on a scale
Standard Deviation 13.7
|
|
Recovery From Mental Illness
Post-intervention 2 (Time 3)
|
93.7 score on a scale
Standard Deviation 14.7
|
91.2 score on a scale
Standard Deviation 13.1
|
SECONDARY outcome
Timeframe: 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
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.
Outcome measures
| Measure |
Experimental
n=251 Participants
Received intervention
|
Control
n=268 Participants
Did not receive intervention
|
|---|---|---|
|
Quality of Life Brief Assessment
Baseline (Time 1)
|
13.1 Score on a Scale
Standard Deviation 2.94
|
13.1 Score on a Scale
Standard Deviation 2.74
|
|
Quality of Life Brief Assessment
Post-intervention 1 (Time 2)
|
13.7 Score on a Scale
Standard Deviation 2.97
|
13.5 Score on a Scale
Standard Deviation 2.79
|
|
Quality of Life Brief Assessment
Post-intervention 2 (Time 3)
|
14.1 Score on a Scale
Standard Deviation 2.83
|
13.4 Score on a Scale
Standard Deviation 2.97
|
Adverse Events
Wellness Recovery Action Planning (WRAP)
Comparison Wait-List Group
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Wellness Recovery Action Planning (WRAP)
n=268 participants at risk
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.
|
Comparison Wait-List Group
n=251 participants at risk
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.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Disorders
|
0.00%
0/268 • 3 years
|
0.40%
1/251 • Number of events 1 • 3 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place