Trial Outcomes & Findings for Illness Management and Recovery for Veterans With Severe Mental Illness (NCT NCT00515671)
NCT ID: NCT00515671
Last Updated: 2021-12-15
Results Overview
Illness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
118 participants
Primary outcome timeframe
Baseline, 9 months, 18 months
Results posted on
2021-12-15
Participant Flow
Participant milestones
| Measure |
Arm 1
Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
Arm 2
Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
|---|---|---|
|
Overall Study
STARTED
|
60
|
58
|
|
Overall Study
COMPLETED
|
43
|
41
|
|
Overall Study
NOT COMPLETED
|
17
|
17
|
Reasons for withdrawal
| Measure |
Arm 1
Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
Arm 2
Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
13
|
10
|
|
Overall Study
Withdrawal by Subject
|
3
|
5
|
|
Overall Study
incarcerated
|
1
|
2
|
Baseline Characteristics
Illness Management and Recovery for Veterans With Severe Mental Illness
Baseline characteristics by cohort
| Measure |
Arm 1
n=60 Participants
Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
Arm 2
n=58 Participants
Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
Total
n=118 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
47.7 years
STANDARD_DEVIATION 9.3 • n=5 Participants
|
47.6 years
STANDARD_DEVIATION 8.5 • n=7 Participants
|
47.7 years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
|
Sex: Female, Male
Female
|
14 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
24 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
46 Participants
n=5 Participants
|
48 Participants
n=7 Participants
|
94 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
white
|
22 participants
n=5 Participants
|
18 participants
n=7 Participants
|
40 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
African American
|
32 participants
n=5 Participants
|
40 participants
n=7 Participants
|
72 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
More than one
|
6 participants
n=5 Participants
|
0 participants
n=7 Participants
|
6 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
60 participants
n=5 Participants
|
58 participants
n=7 Participants
|
118 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline, 9 months, 18 monthsIllness self-management was assessed with the consumer-rated Illness Management and Recovery Scale. Items are rated on a 5-point behaviorally anchored scale; the mean across all 15 items forms an overall score of illness management (ranging from 1 to 5), with higher scores indicating better self-management.
Outcome measures
| Measure |
Arm 1
n=60 Participants
Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
Arm 2
n=58 Participants
Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
|---|---|---|
|
Illness Management Ratings
Illness Management-baseline
|
3.5 units on a scale
Standard Deviation .5
|
3.3 units on a scale
Standard Deviation .5
|
|
Illness Management Ratings
Illness Management-9 months
|
3.5 units on a scale
Standard Deviation .6
|
3.6 units on a scale
Standard Deviation .6
|
|
Illness Management Ratings
Illness Management - 18 months
|
3.6 units on a scale
Standard Deviation .5
|
3.5 units on a scale
Standard Deviation .6
|
SECONDARY outcome
Timeframe: Baseline, 9 months, 18 monthsPsychiatric symptomatology was assessed by the Positive and Negative Syndrome Scale (PANSS), a widely-used, 30-item rating scale. The PANSS has previously demonstrated satisfactory internal consistency, test-retest reliability, and validity. Raters were trained to reach inter-rater agreement of .80 prior to interviewing participants. This is the total score, which ranges from 30 to 210, with higher scores indicating more severe symptoms.
Outcome measures
| Measure |
Arm 1
n=60 Participants
Receives IMR groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
Arm 2
n=58 Participants
Receives support groups once a week for 9 months in addition to care as usual.
Illness Management and Recovery Training: a structured curriculum to help mental health consumers manage their illnesses and pursue goals related to recovery from mental illness
|
|---|---|---|
|
Psychiatric Symptoms (PANSS Total)
Total Symptoms - Baseline
|
75.1 units on a scale
Standard Deviation 16.1
|
76.1 units on a scale
Standard Deviation 15.3
|
|
Psychiatric Symptoms (PANSS Total)
Total Symptoms - 9 months
|
68.5 units on a scale
Standard Deviation 18.5
|
66.6 units on a scale
Standard Deviation 14.9
|
|
Psychiatric Symptoms (PANSS Total)
Total Symptoms - 18 months
|
61.9 units on a scale
Standard Deviation 17.1
|
65.3 units on a scale
Standard Deviation 19.6
|
Adverse Events
Arm 1
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Arm 2
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place