NCT01041976

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
168

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Jan 2011

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 31, 2009

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 5, 2010

Completed
12 months until next milestone

Study Start

First participant enrolled

January 1, 2011

Completed
3.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2014

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2015

Completed
28 days until next milestone

Results Posted

Study results publicly available

September 29, 2015

Completed
Last Updated

March 8, 2016

Status Verified

February 1, 2016

Enrollment Period

3.3 years

First QC Date

December 31, 2009

Results QC Date

August 24, 2015

Last Update Submit

February 8, 2016

Conditions

Keywords

VeteransVocational Rehabilitation

Outcome Measures

Primary Outcomes (1)

  • 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.

    18 months

Secondary Outcomes (1)

  • Employment

    18 months

Study Arms (2)

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.

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.

Behavioral: Support and Education for Recovery (SER)

Interventions

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.

Adapted Motivational Interviewing (AMI)

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.

Support and Education for Recovery (SER)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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)

You may not qualify if:

  • Currently in prison
  • Not able to provide informed consent
  • Not able to speak and understand English

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

Bedford, Massachusetts, 01730, United States

Location

MeSH Terms

Conditions

Psychotic DisordersBipolar Disorder

Interventions

Palliative CareEducational StatusSalvage Therapy

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic DisordersMental DisordersBipolar and Related DisordersMood Disorders

Intervention Hierarchy (Ancestors)

Patient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and ServicesSocioeconomic FactorsPopulation Characteristics

Results Point of Contact

Title
Lisa Mueller
Organization
Edith Nourse Rogers Memorial VA

Study Officials

  • Lisa Mueller, PhD MSEd

    Edith Nourse Rogers Memorial Veterans Hospital, Bedford, MA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 31, 2009

First Posted

January 5, 2010

Study Start

January 1, 2011

Primary Completion

May 1, 2014

Study Completion

September 1, 2015

Last Updated

March 8, 2016

Results First Posted

September 29, 2015

Record last verified: 2016-02

Locations