Ignite Creation Date:
2025-12-24 @ 10:58 PM
Ignite Modification Date:
2026-02-24 @ 2:29 PM
Study NCT ID:
NCT01024569
Status:
COMPLETED
Last Update Posted:
2020-01-10
First Post:
2009-12-02
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Randomized Controlled Trial of Wellness Recovery Action Planning
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'jcook@uic.edu', 'phone': '312-355-3921', 'title': 'Judith A Cook', 'organization': 'University of Illinois at Chicago'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'timeFrame': '3 years', 'eventGroups': [{'id': 'EG000', 'title': 'Wellness Recovery Action Planning (WRAP)', '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.\n\nWellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.', 'otherNumAtRisk': 268, 'deathsNumAtRisk': 268, 'otherNumAffected': 1, 'seriousNumAtRisk': 268, 'deathsNumAffected': 4, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Comparison Wait-List Group', 'description': '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.', 'otherNumAtRisk': 251, 'deathsNumAtRisk': 251, 'otherNumAffected': 1, 'seriousNumAtRisk': 251, 'deathsNumAffected': 6, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Psychiatric Disorders', 'notes': "At the Time 2 interview, subject mentioned that she had been thinking about harming herself and had been feeling this way for several weeks. The interviewer activated the study's crisis protocol and followed up with subject.", 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}, {'term': 'Psychiatric Disorders', 'notes': 'At the Time 1 interview, subject responded that she had been "a little bothered" by suicidal thoughts during the past week, due to the recent death of her daughter. The study\'s crisis protocol was activated and subject was followed up with.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 268, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 251, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Received intervention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Did not receive intervention'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '20.6', 'spread': '14.67', 'groupId': 'OG000'}, {'value': '19.29', 'spread': '14.09', 'groupId': 'OG001'}]}]}, {'title': 'Postintervention 1', 'categories': [{'measurements': [{'value': '19.52', 'spread': '13.74', 'groupId': 'OG000'}, {'value': '21.38', 'spread': '13.68', 'groupId': 'OG001'}]}]}, {'title': 'Postintervention 2', 'categories': [{'measurements': [{'value': '12.20', 'spread': '15.22', 'groupId': 'OG000'}, {'value': '12.65', 'spread': '15.00', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.027', 'groupIds': ['OG000', 'OG001'], 'paramType': 'MIXREG Estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '-1.16', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '-2.21', 'statisticalMethod': 'Mixed Effects Random Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.", 'unitOfMeasure': 'symptom severity score', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Hopefulness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Wellness Recovery Action Planning (WRAP)', '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.\n\nWellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.'}, {'id': 'OG001', 'title': 'Comparison Wait-List Group', 'description': '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.'}], 'classes': [{'title': 'Baseline', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '264', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '21.67', 'spread': '4.66', 'groupId': 'OG000'}, {'value': '21.87', 'spread': '4.42', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 1', 'denoms': [{'units': 'Participants', 'counts': [{'value': '221', 'groupId': 'OG000'}, {'value': '228', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.47', 'spread': '4.39', 'groupId': 'OG000'}, {'value': '22.07', 'spread': '4.06', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '22.76', 'spread': '4.68', 'groupId': 'OG000'}, {'value': '22.16', 'spread': '4.21', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.020', 'groupIds': ['OG000', 'OG001'], 'paramType': 'MIXREG Estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.40', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '2.37', 'groupDescription': 'Mixed Effects Random Regression analysis was used to assess the effects of study condition on Hope outcomes.', 'statisticalMethod': 'Mixed Effects Random Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.'}, {'type': 'PRIMARY', 'title': 'Patient Self-Advocacy', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Received intervention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Did not receive intervention'}], 'classes': [{'title': 'Baseline (Time 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.47', 'spread': '0.50', 'groupId': 'OG000'}, {'value': '3.46', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 1 (Time 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.61', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '3.53', 'spread': '0.53', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 2 (Time 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '220', 'groupId': 'OG000'}, {'value': '227', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '3.65', 'spread': '0.52', 'groupId': 'OG000'}, {'value': '3.55', 'spread': '0.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.029', 'groupIds': ['OG000', 'OG001'], 'paramType': 'MIXREG Estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.05', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.02', 'statisticalMethod': 'Mixed Effects Random Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline'}, {'type': 'PRIMARY', 'title': 'Recovery From Mental Illness', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Received intervention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Did not receive intervention'}], 'classes': [{'title': 'Baseline (Time 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '248', 'groupId': 'OG000'}, {'value': '265', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '88.2', 'spread': '14.9', 'groupId': 'OG000'}, {'value': '87.4', 'spread': '13.2', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 1 (Time 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '222', 'groupId': 'OG000'}, {'value': '231', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '92.9', 'spread': '14.2', 'groupId': 'OG000'}, {'value': '90.0', 'spread': '13.7', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 2 (Time 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '217', 'groupId': 'OG000'}, {'value': '222', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '93.7', 'spread': '14.7', 'groupId': 'OG000'}, {'value': '91.2', 'spread': '13.1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.042', 'groupIds': ['OG000', 'OG001'], 'paramType': 'MIXREG Estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '1.06', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.52', 'statisticalMethod': 'Mixed Effects Random Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed reflects the number of participants at Time 1/Baseline.'}, {'type': 'SECONDARY', 'title': 'Quality of Life Brief Assessment', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Experimental', 'description': 'Received intervention'}, {'id': 'OG001', 'title': 'Control', 'description': 'Did not receive intervention'}], 'classes': [{'title': 'Baseline (Time 1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'OG000'}, {'value': '268', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.1', 'spread': '2.94', 'groupId': 'OG000'}, {'value': '13.1', 'spread': '2.74', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 1 (Time 2)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '224', 'groupId': 'OG000'}, {'value': '234', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '13.7', 'spread': '2.97', 'groupId': 'OG000'}, {'value': '13.5', 'spread': '2.79', 'groupId': 'OG001'}]}]}, {'title': 'Post-intervention 2 (Time 3)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '212', 'groupId': 'OG000'}, {'value': '219', 'groupId': 'OG001'}]}], 'categories': [{'measurements': [{'value': '14.1', 'spread': '2.83', 'groupId': 'OG000'}, {'value': '13.4', 'spread': '2.97', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '.001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'MIXREG Estimate', 'ciNumSides': 'TWO_SIDED', 'paramValue': '0.39', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.11', 'statisticalMethod': 'Mixed Effects Random Regression', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'MEAN', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.', 'unitOfMeasure': 'Score on a Scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Overall Number of Participants Analyzed reflects the number of participants at Time 1'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Wellness Recovery Action Planning (WRAP)', '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.\n\nWellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.'}, {'id': 'FG001', 'title': 'Comparison Wait-List Group', 'description': '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.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '276'}, {'groupId': 'FG001', 'numSubjects': '279'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '251'}, {'groupId': 'FG001', 'numSubjects': '268'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '25'}, {'groupId': 'FG001', 'numSubjects': '11'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '251', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Wellness Recovery Action Planning (WRAP)', '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.\n\nWellness Recovery Action Planning (WRAP): WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.'}, {'id': 'BG001', 'title': 'Comparison Wait-List Group', 'description': '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.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '45.7', 'spread': '9.8', 'groupId': 'BG000'}, {'value': '45.8', 'spread': '9.9', 'groupId': 'BG001'}, {'value': '45.8', 'spread': '9.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '168', 'groupId': 'BG000'}, {'value': '174', 'groupId': 'BG001'}, {'value': '342', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '83', 'groupId': 'BG000'}, {'value': '94', 'groupId': 'BG001'}, {'value': '177', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '15', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '76', 'groupId': 'BG000'}, {'value': '70', 'groupId': 'BG001'}, {'value': '146', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '167', 'groupId': 'BG000'}, {'value': '186', 'groupId': 'BG001'}, {'value': '353', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '251', 'groupId': 'BG000'}, {'value': '268', 'groupId': 'BG001'}, {'value': '519', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Study Site', 'classes': [{'categories': [{'title': 'Canton', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '43', 'groupId': 'BG001'}, {'value': '81', 'groupId': 'BG002'}]}, {'title': 'Cleveland', 'measurements': [{'value': '51', 'groupId': 'BG000'}, {'value': '47', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Columbus', 'measurements': [{'value': '52', 'groupId': 'BG000'}, {'value': '55', 'groupId': 'BG001'}, {'value': '107', 'groupId': 'BG002'}]}, {'title': 'Dayton', 'measurements': [{'value': '12', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}]}, {'title': 'Lorain', 'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '57', 'groupId': 'BG001'}, {'value': '110', 'groupId': 'BG002'}]}, {'title': 'Toledo', 'measurements': [{'value': '45', 'groupId': 'BG000'}, {'value': '52', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Diagnostic and Statistical Manual Diploma in Social Medicine (DSM-IV) Diagnosis', 'classes': [{'categories': [{'title': 'Schizophrenia', 'measurements': [{'value': '29', 'groupId': 'BG000'}, {'value': '29', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Schizoaffective', 'measurements': [{'value': '26', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '47', 'groupId': 'BG002'}]}, {'title': 'Bipolar', 'measurements': [{'value': '95', 'groupId': 'BG000'}, {'value': '93', 'groupId': 'BG001'}, {'value': '188', 'groupId': 'BG002'}]}, {'title': 'Depressive', 'measurements': [{'value': '60', 'groupId': 'BG000'}, {'value': '65', 'groupId': 'BG001'}, {'value': '125', 'groupId': 'BG002'}]}, {'title': 'Other', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '42', 'groupId': 'BG001'}, {'value': '76', 'groupId': 'BG002'}]}, {'title': 'Missing', 'measurements': [{'value': '7', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '25', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 555}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-12', 'completionDateStruct': {'date': '2009-10', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-12-20', 'studyFirstSubmitDate': '2009-12-02', 'resultsFirstSubmitDate': '2019-11-13', 'studyFirstSubmitQcDate': '2009-12-02', 'lastUpdatePostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2019-12-20', 'studyFirstPostDateStruct': {'date': '2009-12-03', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2020-01-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2009-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychiatric Symptoms Recovery Using the Brief Symptoms Inventory (BSI)', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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."}, {'measure': 'Hopefulness', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.'}, {'measure': 'Patient Self-Advocacy', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.'}, {'measure': 'Recovery From Mental Illness', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.'}], 'secondaryOutcomes': [{'measure': 'Quality of Life Brief Assessment', 'timeFrame': 'Study entry (pre-intervention), 8-weeks later (post-intervention), & 6-months after intervention (approx. 8 months after study entry)', '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.'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'keywords': ['Severe Mental Illness', 'Recovery', 'Psychiatric Disability', 'Wellness', 'Peer Service', 'WRAP'], 'conditions': ['Mental Disorders']}, 'referencesModule': {'references': [{'pmid': '21402724', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22508435', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '22167660', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '8636885', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '29407723', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '16370972', 'type': 'RESULT', 'citation': '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.'}, {'pmid': '15085902', 'type': 'RESULT', 'citation': "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."}], 'seeAlsoLinks': [{'url': 'http://www.cmhsrp.uic.edu/nrtc/', 'label': 'University of Illinois at Chicago National Research \\& Training Center'}]}, 'descriptionModule': {'briefSummary': '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:\n\nHypothesis #1: Compared to wait-list control subjects, those who participate in the WRAP intervention will report reduced levels of psychiatric symptoms.\n\nHypothesis #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.\n\nHypothesis #3: Compared to wait-list controls, those who participate in the WRAP intervention will report increased levels of social support.\n\nHypothesis #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.\n\nHypothesis #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.\n\nHypothesis #6: There will be no difference in employment rates of control vs. intervention subjects.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* age 18 years or older\n* English speaking\n* 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.\n\nExclusion Criteria\n\n* non English speaking\n* not meeting clinical criteria for severe mental illness'}, 'identificationModule': {'nctId': 'NCT01024569', 'acronym': 'WRAP RCT', 'briefTitle': 'Randomized Controlled Trial of Wellness Recovery Action Planning', 'organization': {'class': 'OTHER', 'fullName': 'University of Illinois at Chicago'}, 'officialTitle': 'Mental Illness Self-Management Through Wellness Recovery Action Planning In Ohio', 'orgStudyIdInfo': {'id': '2006-0103'}, 'secondaryIdInfos': [{'id': 'UIC WRAP Study', 'type': 'OTHER_GRANT', 'domain': 'H133B050003'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wellness Recovery Action Planning (WRAP)', '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.', 'interventionNames': ['Behavioral: Wellness Recovery Action Planning (WRAP)']}, {'type': 'NO_INTERVENTION', 'label': 'Comparison Wait-List Group', 'description': '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.'}], 'interventions': [{'name': 'Wellness Recovery Action Planning (WRAP)', 'type': 'BEHAVIORAL', 'description': 'WRAP consists of 8 sessions lasting for 2-½ hours, convened once a week over a period of 8 weeks.', 'armGroupLabels': ['Wellness Recovery Action Planning (WRAP)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60612', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'University of Illinois at Chicago, Department of Psychiatry', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'overallOfficials': [{'name': 'Judith A. Cook, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Illinois at Chicago, Department of Psychiatry'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Illinois at Chicago', 'class': 'OTHER'}, 'collaborators': [{'name': 'U.S. Department of Education', 'class': 'FED'}, {'name': 'Substance Abuse and Mental Health Services Administration (SAMHSA)', 'class': 'FED'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Psychiatry', 'investigatorFullName': 'Judith A. Cook', 'investigatorAffiliation': 'University of Illinois at Chicago'}}}}