Psychotic DisordersPhase 2NCT01041976
Supported Employment: Motivational Enhancement for Entry and Outcome
A Phase 2 study testing Adapted Motivational Interviewing (AMI) and Support and Education for Recovery (SER) in people with Psychotic Disorders and Bipolar Disorder, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Psychotic Disorders, Bipolar Disorder, Unemployment
- What is being tested?
- Adapted Motivational Interviewing (AMI) and Support and Education for Recovery (SER)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 168 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2011to Sep 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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)
Who cannot join
- Currently in prison
- Not able to provide informed consent
- Not able to speak and understand English
Trial locations and contacts
1 site in 1 country.
United States1 site
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Bedford, Massachusetts, 01730
About this study
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.
Read the 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.
- Conditions
- Psychotic Disorders, Bipolar Disorder, Unemployment
- Being tested
- Adapted Motivational Interviewing (AMI), Support and Education for Recovery (SER)
- Keywords
- Veterans, Vocational Rehabilitation
- Medical subject headings
- Psychotic Disorders, Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adapted Motivational Interviewing (AMI)Behavioural
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)Behavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Adapted Motivational Interviewing (AMI) | Experimental | 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. Receives: Behavioral: Adapted Motivational Interviewing (AMI) |
| Support and Education for Recovery (SER) | Placebo comparator | 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. Receives: Behavioral: Support and Education for Recovery (SER) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participation in Vocational Rehabilitation Services
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.
Measured: 18 months
Secondary outcomes (1)
Employment
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.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jan 2010 (estimated)
- Study startJan 2011
- Primary completionMay 2014
- Study completionSep 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psychotic DisordersStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 168 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Lisa Mueller, PhD MSEd, Principal investigator, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01041976
- Sponsor's protocol ID
- D7306-R
- Status last verified
- Feb 2016
- First submitted
- 31 Dec 2009
- Last updated
- 8 Mar 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Supported Employment: Motivational Enhancement for Entry and Outcome
- ClinicalTrials.gov ID
- NCT01041976
- Acronym / sponsor ID
- D7306-R
- Conditions
- Psychotic Disorders, Bipolar Disorder, Unemployment
- Keywords
- Veterans, Vocational Rehabilitation
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 168 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Jan 2011
- Primary completion
- May 2014 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 5 Jan 2010 (estimated)
- Results
- Posted 29 Sep 2015
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Adapted Motivational Interviewing (AMI) | Experimental | 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. |
| Support and Education for Recovery (SER) | Placebo comparator | 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (3 listed)
- Currently in prison
- Not able to provide informed consent
- Not able to speak and understand English
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Behavioural | Adapted Motivational Interviewing (AMI) |
| 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. | Behavioural | Support and Education for Recovery (SER) |
Primary outcome
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.
1 secondary outcome
Employment
Time frame: 18 months
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Mar 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Lisa Mueller, PhD MSEd principal investigator
Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Adapted Motivational Interviewing (AMI) and Support and Education for Recovery (SER) in people with Psychotic Disorders and Bipolar Disorder, run by VA Office of Research and Development at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2015). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Participation in Vocational Rehabilitation Services (time frame: 18 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Mar 2016.