Supported Employment: Motivational Enhancement for Entry and Outcome

Sponsor
VA Office of Research and Development (U.S. Fed)
Overall Status
Completed
CT.gov ID
NCT01041976
Collaborator
(none)
168
1
2
56
3

Study Details

Study Description

Brief Summary

The purpose of this study is to compare 6 monthly counseling sessions to 6 monthly information sessions on Veterans' decisions to (a) participate in vocational rehabilitation services and (b) become employed.

Condition or Disease Intervention/Treatment Phase
  • Behavioral: Adapted Motivational Interviewing (AMI)
  • Behavioral: Support and Education for Recovery (SER)
Phase 2

Detailed Description

Approximately 85-90% of those with serious mental illness are unemployed (9, 10). This level of unemployment exists despite the finding that, among people who have a psychiatric disability and are unemployed, 55-61% desire employment, with the total reaching 75% when concern about losing benefits was taken into account (1, 2). The rewards of employment for adults with SMI are greater than simply an increase in financial resources. Studies have found that people with serious mental illness who worked competitively scored higher on measures of self-esteem, satisfaction with finances, leisure, and overall life satisfaction compared to those worked little or not at all (11). Supported employment (SE) has been more effective than any other vocational rehabilitation approach for this population (3, 4) and the VA has mandated that SE be integrated into all current VHA Compensated Work Therapy (CWT) programs (VHA Directive 2007-005). Two areas of concern include (a) national utilization of SE services is low (13), and (b) the percentage of SE participants who obtain at least one job during the studies averages 56% even though everyone who enters the program expressed an interest in working (13).

Motivational interviewing (MI) is an evidence-based practice that has been effective in enhancing a range of clinical services (6), but has just recently been applied to employment and vocational services by Drebing et al. (7) and Glynn et al (8).

The proposed project is a randomized trial of Adapted Motivational Interviewing for Supported Employment (AMI-SE) provided to Veterans and their significant others (family members or key friends) in order to address the internal and external barriers to the Veteran enrolling in supported employment and returning to work.

Study Design

Study Type:
Interventional
Actual Enrollment :
168 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Supported Employment: Motivational Enhancement for Entry and Outcome
Study Start Date :
Jan 1, 2011
Actual Primary Completion Date :
May 1, 2014
Actual Study Completion Date :
Sep 1, 2015

Arms and Interventions

Arm Intervention/Treatment
Experimental: 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.

Behavioral: 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.

Placebo Comparator: 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.

Behavioral: 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.

Outcome Measures

Primary Outcome Measures

  1. Participation in Vocational Rehabilitation Services [18 months]

    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.

Secondary Outcome Measures

  1. Employment [18 months]

    Yes/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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
Inclusion Criteria:
  • Eligible to receive VA services

  • Diagnosis of serious mental illness: schizophrenia, schizoaffective, psychosis NOS, bipolar disorder, or depression with psychotic features

  • Currently unemployed

  • Not currently enrolled in Supported Employment services

  • Expects to stay within 100 miles of Bedford, MA for the next 18 months

  • Has a significant other (friend or family member) who is also willing to participate (a criterion required only from March 2011 to March 2012 of the recruitment period)

Exclusion Criteria:
  • Currently in prison

  • Not able to provide informed consent

  • Not able to speak and understand English

Contacts and Locations

Locations

Site City State Country Postal Code
1 Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA Bedford Massachusetts United States 01730

Sponsors and Collaborators

  • VA Office of Research and Development

Investigators

  • Principal Investigator: Lisa Mueller, PhD MSEd, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01041976
Other Study ID Numbers:
  • D7306-R
First Posted:
Jan 5, 2010
Last Update Posted:
Mar 8, 2016
Last Verified:
Feb 1, 2016
Keywords provided by VA Office of Research and Development
Additional relevant MeSH terms:

Study Results

Participant Flow

Recruitment Details 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.
Pre-assignment Detail 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.
Arm/Group Title Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER)
Arm/Group Description 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. 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.
Period Title: Overall Study
STARTED 42 42
6 Month Follow-up 39 41
12 Month Follow-up 37 38
18 Month Follow-up 37 38
COMPLETED 37 38
NOT COMPLETED 5 4

Baseline Characteristics

Arm/Group Title Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER) Total
Arm/Group Description 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. 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 of all reporting groups
Overall Participants 42 42 84
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]
52.9
(11.0)
53.0
(8.6)
53.0
(9.8)
Sex: Female, Male (Count of Participants)
Female
4
9.5%
0
0%
4
4.8%
Male
38
90.5%
42
100%
80
95.2%
Race/Ethnicity, Customized (participants) [Number]
American Indian/Alaskan
0
0%
1
2.4%
1
1.2%
Asian/Pacific Islander
1
2.4%
0
0%
1
1.2%
Black/African-American
9
21.4%
6
14.3%
15
17.9%
White
27
64.3%
28
66.7%
55
65.5%
Multi-racial
2
4.8%
5
11.9%
7
8.3%
Hispanic/Latino, White
3
7.1%
2
4.8%
5
6%
Hispanic/Latino, Black
0
0%
0
0%
0
0%
Region of Enrollment (participants) [Number]
United States
42
100%
42
100%
84
100%

Outcome Measures

1. Primary Outcome
Title Participation in Vocational Rehabilitation Services
Description 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.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER)
Arm/Group Description 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. 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.
Measure Participants 42 42
Number [participants]
19
45.2%
3
7.1%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapted Motivational Interviewing (AMI), Support and Education for Recovery (SER)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.001
Comments
Method Chi-squared
Comments
2. Secondary Outcome
Title Employment
Description Yes/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.
Time Frame 18 months

Outcome Measure Data

Analysis Population Description
[Not Specified]
Arm/Group Title Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER)
Arm/Group Description 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. 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.
Measure Participants 42 42
Number [participants]
12
28.6%
4
9.5%
Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Adapted Motivational Interviewing (AMI), Support and Education for Recovery (SER)
Comments
Type of Statistical Test Superiority or Other
Comments
Statistical Test of Hypothesis p-Value <0.05
Comments
Method Chi-squared
Comments

Adverse Events

Time Frame Adverse events were collected during the time period beginning with informed consent and ending with the 18 month follow-up for each participant.
Adverse Event Reporting Description
Arm/Group Title Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER)
Arm/Group Description 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. 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.
All Cause Mortality
Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total / (NaN) / (NaN)
Serious Adverse Events
Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 15/42 (35.7%) 20/42 (47.6%)
General disorders
Medical Hospitalization 5/42 (11.9%) 7 9/42 (21.4%) 13
Death 0/42 (0%) 0 4/42 (9.5%) 4
Psychiatric disorders
Psychiatric Hospitalization 13/42 (31%) 22 14/42 (33.3%) 38
Social circumstances
Arrest & Incarceration 2/42 (4.8%) 3 0/42 (0%) 0
Other (Not Including Serious) Adverse Events
Adapted Motivational Interviewing (AMI) Support and Education for Recovery (SER)
Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total 0/42 (0%) 3/42 (7.1%)
General disorders
Emergency Room Visit 0/42 (0%) 0 2/42 (4.8%) 3
Transfer Within Hospital 0/42 (0%) 0 1/42 (2.4%) 1

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

Results Point of Contact

Name/Title Lisa Mueller
Organization Edith Nourse Rogers Memorial VA
Phone 781-687-3192
Email Lisa.Mueller@va.gov
Responsible Party:
VA Office of Research and Development
ClinicalTrials.gov Identifier:
NCT01041976
Other Study ID Numbers:
  • D7306-R
First Posted:
Jan 5, 2010
Last Update Posted:
Mar 8, 2016
Last Verified:
Feb 1, 2016