- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01041976
Supported Employment: Motivational Enhancement for Entry and Outcome
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Massachusetts
-
Bedford, Massachusetts, United States, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Participation in Vocational Rehabilitation Services
Time Frame: 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. |
18 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Employment
Time Frame: 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. |
18 months
|
Collaborators and Investigators
Investigators
- Principal Investigator: Lisa Mueller, PhD MSEd, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- D7306-R
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Psychotic Disorders
-
Medical College of WisconsinCompletedSchizophrenia | Affective Disorders | Psychotic Disorder | Psychotic Mood Disorder
-
Søren Dinesen ØstergaardCompletedAffective Disorders, PsychoticDenmark
-
Instituto de Investigación Hospital Universitario...Carlos III Health Institute; European Regional Development FundCompletedSchizophrenia and Disorders With Psychotic Features | Psychotic EpisodeSpain
-
Centre hospitalier de Ville-Evrard, FranceRecruiting
-
Instituto de Investigación Hospital Universitario...CompletedSchizophrenia and Disorders With Psychotic Feature | Psychotic EpisodeSpain
-
University Hospital, Strasbourg, FranceRecruiting
-
University of California, San DiegoCompletedSchizophrenia | Schizoaffective Disorder | Mood Disorder, PsychoticUnited States
-
University Hospital, CaenRecruiting
-
Philipp HomanRecruitingPsychotic DisorderCzechia, Ireland, Netherlands, Norway, Switzerland, Turkey (Türkiye)
-
University of MinnesotaUniversity of California, San FranciscoCompletedPsychotic Disorders | Schizophrenia | Schizoaffective Disorder | Cognitive Impairment | Psychosis | Treatment | Psychotic Depression | Psychotic Episode | Active Control | Psychotic Mood DisordersUnited States
Clinical Trials on Adapted Motivational Interviewing (AMI)
-
Toronto Metropolitan UniversityThe Jackman Foundation; BMS Canada Risk Services Ltd.; Canadian Psychological... and other collaboratorsCompletedBinge Eating | Food AddictionCanada
-
Université Sorbonne Paris NordLigue contre le cancer, France; Garmin International; StimulabRecruitingBreast Cancer | Lung Cancer | Prostate Cancer | Colo-rectal CancerFrance
-
University of New MexicoNational Institute on Drug Abuse (NIDA)Completed
-
University of Maryland, BaltimoreMaryland Department of Health and Mental HygieneCompletedFractures, Bone | Smoking, TobaccoUnited States
-
Johns Hopkins UniversityZanvyl and Isabelle Krieger FundCompleted
-
Massachusetts General HospitalCompletedACS - Acute Coronary SyndromeUnited States
-
Washington University School of MedicineNational Institute of Mental Health (NIMH)Completed
-
Veterans Medical Research FoundationThe Tug McGraw FoundationCompleted
-
Qazvin University Of Medical SciencesCompletedObesity, AdolescentIran, Islamic Republic of
-
University of MichiganNational Heart, Lung, and Blood Institute (NHLBI); University of Iowa; American... and other collaboratorsCompletedChildhood ObesityUnited States