Trial Outcomes & Findings for Supported Employment: Motivational Enhancement for Entry and Outcome (NCT NCT01041976)
NCT ID: NCT01041976
Last Updated: 2016-03-08
Results Overview
Yes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up. Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
168 participants
Primary outcome timeframe
18 months
Results posted on
2016-03-08
Participant Flow
Participants were recruited from a variety of clinics at the Edith Nourse Rogers Memorial VA Hospital including: the Psychosocial Rehabilitation and Recovery Center, Mental Health Intensive Case Management (MHICM), outpatient Prolixin and Clozaril clinics, VA Supported Housing (VASH), and the psychiatric inpatient unit.
168 participants enrolled, 115 veterans+53 family/key friends willing to participate, a criterion only for 3/2011-3/2012 recruitment. Veterans completed screening interview and if eligible completed the informed consent process and baseline interview. During 1st session with individual research clinician 84 Veterans were randomized to AMI or SER.
Participant milestones
| Measure |
Adapted Motivational Interviewing (AMI)
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
|
Support and Education for Recovery (SER)
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
|
|---|---|---|
|
Overall Study
STARTED
|
42
|
42
|
|
Overall Study
6 Month Follow-up
|
39
|
41
|
|
Overall Study
12 Month Follow-up
|
37
|
38
|
|
Overall Study
18 Month Follow-up
|
37
|
38
|
|
Overall Study
COMPLETED
|
37
|
38
|
|
Overall Study
NOT COMPLETED
|
5
|
4
|
Reasons for withdrawal
| Measure |
Adapted Motivational Interviewing (AMI)
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
|
Support and Education for Recovery (SER)
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
3
|
0
|
|
Overall Study
Incarceration
|
2
|
0
|
|
Overall Study
Death
|
0
|
4
|
Baseline Characteristics
Supported Employment: Motivational Enhancement for Entry and Outcome
Baseline characteristics by cohort
| Measure |
Adapted Motivational Interviewing (AMI)
n=42 Participants
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
|
Support and Education for Recovery (SER)
n=42 Participants
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
|
Total
n=84 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
52.9 years
STANDARD_DEVIATION 11.0 • n=5 Participants
|
53.0 years
STANDARD_DEVIATION 8.6 • n=7 Participants
|
53.0 years
STANDARD_DEVIATION 9.8 • n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
38 Participants
n=5 Participants
|
42 Participants
n=7 Participants
|
80 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
American Indian/Alaskan
|
0 participants
n=5 Participants
|
1 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian/Pacific Islander
|
1 participants
n=5 Participants
|
0 participants
n=7 Participants
|
1 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
9 participants
n=5 Participants
|
6 participants
n=7 Participants
|
15 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
27 participants
n=5 Participants
|
28 participants
n=7 Participants
|
55 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Multi-racial
|
2 participants
n=5 Participants
|
5 participants
n=7 Participants
|
7 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino, White
|
3 participants
n=5 Participants
|
2 participants
n=7 Participants
|
5 participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic/Latino, Black
|
0 participants
n=5 Participants
|
0 participants
n=7 Participants
|
0 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
42 participants
n=5 Participants
|
42 participants
n=7 Participants
|
84 participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 18 monthsYes/No: Did veteran complete an intake for a VA Supported Employment program at any time from randomization to 18 month follow-up. Outcome: Number of participants who completed an intake for VA Supported Employment program at any time from randomization to 18 month follow-up.
Outcome measures
| Measure |
Adapted Motivational Interviewing (AMI)
n=42 Participants
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
|
Support and Education for Recovery (SER)
n=42 Participants
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
|
|---|---|---|
|
Participation in Vocational Rehabilitation Services
|
19 participants
|
3 participants
|
SECONDARY outcome
Timeframe: 18 monthsYes/No: Did veteran work at least one day in a competitive job at any time from randomization to 18 month follow-up. Outcome: Number of participants who worked at least one day in a competitive job at any time from randomization to 18 month follow-up.
Outcome measures
| Measure |
Adapted Motivational Interviewing (AMI)
n=42 Participants
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
|
Support and Education for Recovery (SER)
n=42 Participants
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
|
|---|---|---|
|
Employment
|
12 participants
|
4 participants
|
Adverse Events
Adapted Motivational Interviewing (AMI)
Serious events: 15 serious events
Other events: 0 other events
Deaths: 0 deaths
Support and Education for Recovery (SER)
Serious events: 20 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Adapted Motivational Interviewing (AMI)
n=42 participants at risk
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
|
Support and Education for Recovery (SER)
n=42 participants at risk
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
|
|---|---|---|
|
Psychiatric disorders
Psychiatric Hospitalization
|
31.0%
13/42 • Number of events 22 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
33.3%
14/42 • Number of events 38 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
|
General disorders
Medical Hospitalization
|
11.9%
5/42 • Number of events 7 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
21.4%
9/42 • Number of events 13 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
|
General disorders
Death
|
0.00%
0/42 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
9.5%
4/42 • Number of events 4 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
|
Social circumstances
Arrest & Incarceration
|
4.8%
2/42 • Number of events 3 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
0.00%
0/42 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
Other adverse events
| Measure |
Adapted Motivational Interviewing (AMI)
n=42 participants at risk
Veterans assigned to the AMI condition will be scheduled for up to 6 sessions over 6 months. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). Sessions will utilize a variety of motivational enhancement strategies including evocative questions, importance and confidence scales, collaborative problem solving, and planning.
|
Support and Education for Recovery (SER)
n=42 participants at risk
Veterans assigned to the control condition will be seen for 6 sessions over 6 months of basic support and education about VA and non-VA psychiatric rehabilitation and recovery services. Up to 3 of these 6 sessions will be joint sessions with the veteran's significant other (if available). The session topics include information about Bedford VA and Boston VA recovery services, as well as those offered by local non-profits.
|
|---|---|---|
|
General disorders
Emergency Room Visit
|
0.00%
0/42 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
4.8%
2/42 • Number of events 3 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
|
General disorders
Transfer Within Hospital
|
0.00%
0/42 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
2.4%
1/42 • Number of events 1 • Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place