Trial Outcomes & Findings for Building Employment Skills Through Therapy for Veterans (NCT NCT01992913)
NCT ID: NCT01992913
Last Updated: 2025-01-22
Results Overview
Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
67 participants
Primary outcome timeframe
Baseline to post-treatment (18-months)
Results posted on
2025-01-22
Participant Flow
Veterans receiving treatment for schizophrenia or schizoaffective disorder at the Corporal Michael Crescenz VA Medical Center in the Mental Health Clinic were offered the opportunity to participate in a research project meant to test whether a CBT group treatment that included cognitive remediation enhanced the employment outcomes of a standard Supported Employment program. Recruitment began 6/2015 and enrollment ended 7/2019.
Eighty-seven Veterans completed baseline assessment and met study criteria. Twenty Veterans subsequently withdrew or were administratively withdrawn for clinical reasons from further participation, prior to randomization. Six more Veterans in the first cohort who were to be randomized to the TAU group were assigned to the iCBT group to obtain sufficient participants for an initial therapy group (i.e., ten to twelve). This violated random assignment, thus were administratively withdrawn.
Participant milestones
| Measure |
Integrated CBT With Computerized Cognitive Remediation
Integrated CBT with computerized cognitive remediation (iCBT)
Integrated Cognitive Behavioral Therapy: Novel CBT group treatment for schizophrenia/schizoaffective disorder
Computerized cognitive remediation (CCR): Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.
Participants were also enrolled in a Supported Employment program to support job attainment and continuation, and any other treatments that were available to Veterans at the VA Medical Center.
|
Treatment As Usual
Treatment As Usual (TAU)
The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition).
Participants were also enrolled in a Supported Employment program to support job attainment and continuation.
|
|---|---|---|
|
Baseline Assessment
STARTED
|
37
|
30
|
|
Baseline Assessment
COMPLETED
|
37
|
30
|
|
Baseline Assessment
NOT COMPLETED
|
0
|
0
|
|
6 Month Assessment
STARTED
|
37
|
30
|
|
6 Month Assessment
COMPLETED
|
37
|
30
|
|
6 Month Assessment
NOT COMPLETED
|
0
|
0
|
|
12 Month Assessment
STARTED
|
37
|
30
|
|
12 Month Assessment
COMPLETED
|
37
|
30
|
|
12 Month Assessment
NOT COMPLETED
|
0
|
0
|
|
18 Month Assessment
STARTED
|
37
|
30
|
|
18 Month Assessment
COMPLETED
|
37
|
30
|
|
18 Month Assessment
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Building Employment Skills Through Therapy for Veterans
Baseline characteristics by cohort
| Measure |
Integrated CBT With Computerized Cognitive Remediation
n=37 Participants
integrated CBT with computerized cognitive remediation
integrated Cognitive Behavioral Therapy: Novel CBT paradigm for schizophrenia/schizoaffective disorder
Computerized cognitive remediation (CCR): Part of the iCBT paradigm, a four month block of bi-weekly computerized cognitive remediation using BrainHQ program.
|
Treatment As Usual
n=30 Participants
Treatment As Usual
Usual Care: The usual care that Veterans receive - not limited in scope (i.e., subjects may participate in any/all available treatments, outside the study condition)
|
Total
n=67 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
46.4 years
STANDARD_DEVIATION 11.9 • n=5 Participants
|
51.3 years
STANDARD_DEVIATION 12.2 • n=7 Participants
|
48.6 years
STANDARD_DEVIATION 12.2 • n=5 Participants
|
|
Sex: Female, Male
Female
|
5 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
32 Participants
n=5 Participants
|
25 Participants
n=7 Participants
|
57 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black of African American
|
25 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
51 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Native American, Alaskan native
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Caucasian
|
9 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Non-Hispanic ethnicity · Hispanic
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Non-Hispanic ethnicity · NonHispanic
|
37 Participants
n=5 Participants
|
29 Participants
n=7 Participants
|
66 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
37 Participants
n=5 Participants
|
30 Participants
n=7 Participants
|
67 Participants
n=5 Participants
|
|
Primary Diagnosis
Schizophrenia
|
31 Participants
n=5 Participants
|
22 Participants
n=7 Participants
|
53 Participants
n=5 Participants
|
|
Primary Diagnosis
Schizoaffective disorder
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Marital status
Never married
|
18 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
|
Marital status
Currently married
|
4 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Marital status
Separated
|
4 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
6 Participants
n=5 Participants
|
|
Marital status
Divorced
|
10 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
18 Participants
n=5 Participants
|
|
Marital status
Widowed
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Marital status
Cohabitating
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Brief Negative Symptom Scale
|
28.5 units on a scale
STANDARD_DEVIATION 12.2 • n=5 Participants
|
28.7 units on a scale
STANDARD_DEVIATION 10.6 • n=7 Participants
|
28.6 units on a scale
STANDARD_DEVIATION 11.4 • n=5 Participants
|
|
Scale for the Assessment of Positive Symptoms
|
27.6 units on a scale
STANDARD_DEVIATION 20.1 • n=5 Participants
|
30.5 units on a scale
STANDARD_DEVIATION 14.3 • n=7 Participants
|
28.9 units on a scale
STANDARD_DEVIATION 17.7 • n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline to post-treatment (18-months)Measure completed by the support employment specialist that evaluates participation in the workforce: Total number of jobs attained per group across the full length of the study (Baseline to 18 month follow-up, study end)
Outcome measures
| Measure |
iCBT Group
n=37 Participants
Integrative Cognitive Behavioral Therapy group (experimental group)
|
TAU Group
n=30 Participants
Treatment as Usual group (control group)
|
|---|---|---|
|
Workforce Participation Measure - Total Number of Jobs Attained
Baseline
|
0 Number of jobs attained
Standard Deviation 0
|
0 Number of jobs attained
Standard Deviation 0
|
|
Workforce Participation Measure - Total Number of Jobs Attained
18 month follow-up (study end)
|
0.95 Number of jobs attained
Standard Deviation 1.2
|
0.43 Number of jobs attained
Standard Deviation 0.68
|
PRIMARY outcome
Timeframe: Study start through 18 months of the active portion of the study.Population: Participants with diagnoses of schizophrenia or schizoaffective disorder seeking employment
This is the proportion of participants, by group, that attained at least one job during the active portion of the study.
Outcome measures
| Measure |
iCBT Group
n=37 Participants
Integrative Cognitive Behavioral Therapy group (experimental group)
|
TAU Group
n=30 Participants
Treatment as Usual group (control group)
|
|---|---|---|
|
Overall Job Attainment Proportion
No job attainment
|
16 Participants
|
20 Participants
|
|
Overall Job Attainment Proportion
At least one job attained
|
21 Participants
|
10 Participants
|
PRIMARY outcome
Timeframe: Baseline to study intervention start point (ranging from 1-10 months), then at 6 months after intervention start, 12 months after intervention start, and then 18 months after intervention start.This is a composite of hours work per week X number of weeks worked, in each assessment period.
Outcome measures
| Measure |
iCBT Group
n=37 Participants
Integrative Cognitive Behavioral Therapy group (experimental group)
|
TAU Group
n=30 Participants
Treatment as Usual group (control group)
|
|---|---|---|
|
Job Participant Composite-hours Worked
Baseline to intervention start point
|
96.5 Hours worked
Standard Deviation 361.1
|
25.3 Hours worked
Standard Deviation 83.6
|
|
Job Participant Composite-hours Worked
Intervention start to 6 mos.
|
109.3 Hours worked
Standard Deviation 228.8
|
27.0 Hours worked
Standard Deviation 118.5
|
|
Job Participant Composite-hours Worked
6-12 mos.
|
110.8 Hours worked
Standard Deviation 221.6
|
77.3 Hours worked
Standard Deviation 169.3
|
|
Job Participant Composite-hours Worked
12-18 mos.
|
123.5 Hours worked
Standard Deviation 245.8
|
133.4 Hours worked
Standard Deviation 304.3
|
SECONDARY outcome
Timeframe: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)Population: Participants from both groups were very reluctant for the interventionists to obtain formal Work Behavior Inventory ratings from their employers. It was clear that insufficient data would be obtained and so efforts to complete it were abandoned. No data analysis was possible with this measure.
Measure completed by the supported employment specialist that evaluates work quality in an employment setting, based on the job supervisor's report, using the overall impression rating, ranging from 1 (consistently needing improvement) to 5 (consistently superior performance). Only the job supervisor's was used, rather than other options possible with the measure.
Outcome measures
| Measure |
iCBT Group
n=1 Participants
Integrative Cognitive Behavioral Therapy group (experimental group)
|
TAU Group
Treatment as Usual group (control group)
|
|---|---|---|
|
Work Behavior Inventory
Baseline
|
5.0 units on a scale
Standard Deviation 0
|
—
|
|
Work Behavior Inventory
6 months
|
4.0 units on a scale
Standard Deviation 0
|
—
|
SECONDARY outcome
Timeframe: Baseline, mid-treatment (6-months), end of treatment (12-months), and post-treatment (18-months)Population: The number of participants available for assessment at each time point varied due to the variability in willingness on the part of the participants to complete these interviews. Thus, data available at each time point for each group varied across time.
This is measure designed to assess individual social, work, and interpersonal functioning of individuals with severe mental illness. The possible total score ranges from 30 - 150 with higher scores representing higher levels of functioning.
Outcome measures
| Measure |
iCBT Group
n=37 Participants
Integrative Cognitive Behavioral Therapy group (experimental group)
|
TAU Group
n=30 Participants
Treatment as Usual group (control group)
|
|---|---|---|
|
Specific Levels of Functioning (SLOF)
Baseline
|
128.0 score on a scale
Standard Deviation 12.87
|
123.0 score on a scale
Standard Deviation 19.33
|
|
Specific Levels of Functioning (SLOF)
6 months
|
125.3 score on a scale
Standard Deviation 18.1
|
127.8 score on a scale
Standard Deviation 10.9
|
|
Specific Levels of Functioning (SLOF)
12 months
|
127.8 score on a scale
Standard Deviation 13.1
|
127.2 score on a scale
Standard Deviation 16.3
|
|
Specific Levels of Functioning (SLOF)
18 months
|
127.9 score on a scale
Standard Deviation 13.3
|
121.1 score on a scale
Standard Deviation 18.7
|
Adverse Events
iCBT Group
Serious events: 12 serious events
Other events: 0 other events
Deaths: 2 deaths
TAU Group
Serious events: 9 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
iCBT Group
n=37 participants at risk
Integrative Cognitive Behavioral Therapy group (experimental group)
|
TAU Group
n=30 participants at risk
Treatment as Usual group (control group)
|
|---|---|---|
|
Psychiatric disorders
Inpatient psychiatric hospitalization
|
32.4%
12/37 • Number of events 28 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
30.0%
9/30 • Number of events 23 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Surgical and medical procedures
Inpatient surgical hospitalization
|
2.7%
1/37 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
3.3%
1/30 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
General disorders
Dizziness
|
5.4%
2/37 • Number of events 2 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
0.00%
0/30 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Gastrointestinal disorders
Bleeding
|
2.7%
1/37 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
0.00%
0/30 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
General disorders
Observation
|
2.7%
1/37 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
0.00%
0/30 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Musculoskeletal and connective tissue disorders
Weakness
|
2.7%
1/37 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
0.00%
0/30 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Gastrointestinal disorders
Colonscopy
|
2.7%
1/37 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
0.00%
0/30 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Musculoskeletal and connective tissue disorders
Hand injury
|
0.00%
0/37 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
3.3%
1/30 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Cardiac disorders
Acute coronary syndrome
|
0.00%
0/37 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
3.3%
1/30 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Surgical and medical procedures
General Medical
|
0.00%
0/37 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
6.7%
2/30 • Number of events 2 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
|
Blood and lymphatic system disorders
UTI/blood infection
|
2.7%
1/37 • Number of events 1 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
|
0.00%
0/30 • Adverse events were noted from study beginning (baseline) until the study end for the last participant. Adverse events were assessed, at minimum, at each major assessment point, from Baseline to intervention start, a period of time that varied across participants from 1 to 10 months, intervention start to the 6 month assessment, 6 months to 12 months assessments, and 12 months to 18 months assessment.
Adverse events were also noted as reported by the Veteran or by clinicians in the medical record of the participants at times other than major assessments. Ongoing medical events not conceivably associated with the study's psychosocial intervention were not noted or reported by study staff, unless the event was accompanied by inpatient treatment or death. This included incarceration, which occurred in two instances for these significantly disordered participants.
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Other adverse events
Adverse event data not reported
Additional Information
Steven L. Sayers, Ph.D.
Corporal Michael J Crescenz VA Medical Center
Phone: (215) 823-5196
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place