- ICH GCP
- Register voor klinische proeven in de VS.
- Klinische proef NCT01041976
Supported Employment: Motivational Enhancement for Entry and Outcome
Studie Overzicht
Toestand
Interventie / Behandeling
Gedetailleerde beschrijving
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.
Studietype
Inschrijving (Werkelijk)
Fase
- Fase 2
Contacten en locaties
Studie Locaties
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Massachusetts
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Bedford, Massachusetts, Verenigde Staten, 01730
- Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
|---|---|
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Experimenteel: 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.
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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.
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Placebo-vergelijker: 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.
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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.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Participation in Vocational Rehabilitation Services
Tijdsspanne: 18 months
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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
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Employment
Tijdsspanne: 18 months
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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
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Medewerkers en onderzoekers
Onderzoekers
- Hoofdonderzoeker: Lisa Mueller, PhD MSEd, Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA
Studie record data
Bestudeer belangrijke data
Studie start
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Schatting)
Updates van studierecords
Laatste update geplaatst (Schatting)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Aanvullende relevante MeSH-voorwaarden
Andere studie-ID-nummers
- D7306-R
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