NCT00272168

Brief Summary

The goal of this study is to evaluate the efficacy of a combined social skills training and cognitive-behavioral therapy intervention for seriously mentally ill Veterans as they begin employment.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
88

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2005

Longer than P75 for not_applicable

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

Study Start

First participant enrolled

October 1, 2005

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

December 30, 2005

Completed
5 days until next milestone

First Posted

Study publicly available on registry

January 4, 2006

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2009

Completed
6.7 years until next milestone

Results Posted

Study results publicly available

June 17, 2016

Completed
Last Updated

June 17, 2016

Status Verified

May 1, 2016

Enrollment Period

4 years

First QC Date

December 30, 2005

Results QC Date

November 13, 2015

Last Update Submit

May 10, 2016

Conditions

Keywords

Cognitive behavioral therapySocial Skills trainingVocational Rehabilitation

Outcome Measures

Primary Outcomes (4)

  • Employment Status

    Data collected included from participants: 1) hours scheduled to work per week and 2) weekly wages earned.

    Post Treatment (approximately 3 months after completion of the baseline assessment)

  • Work Performance (Work Behavior Inventory)

    This measure is completed with participants' supervisors and assesses current work behavior and vocational function. The WBI yields six scores related to fundamental work requirements: social skills, cooperativeness, work habits, work quality personal presentation, and a general score of overall work performance. Each of these is rated between 1-5: 1. Consistently an area Needing Improvement 2. Occasionally an area Needing Improvement 3. Performance Adequate in this area 4. Occasionally an area of Superior Performance 5. Consistently an area of Superior Performance. The global impression of work behavior (overall rating of work functioning using the same 1-5 scale) was used for the purpose of reporting results for this study.

    Post Treatment

  • Social Functioning

    This was assessed using the Maryland Assessment of Social Competence (MASC), which assesses participants social problem solving skill abilities in both work-related and non-work related situations. Using three scenes, the participant is rated on the following scale for each scene. Overall score is then averaged to arrive at a final score. 1. Very Poor 2. Poor 3. Neither good nor poor 4. Somewhat good 5. Very good

    Post Treatment

  • Employment Status

    Data collected included from participants: weekly wages earned

    Post Treatment (approximately 3 months after completion of the baseline assessment)

Secondary Outcomes (2)

  • Cognitive Insight

    Post Treatment

  • Psychiatric Symptoms

    Post-Treatment

Study Arms (2)

Arm 1: MPROVE

EXPERIMENTAL

The Maryland Program for Vocational Effectiveness (MPROVE)

Behavioral: Maryland Program for Vocational Effectiveness

Arm 2: Control

ACTIVE COMPARATOR

Supportive Treatment for SMI (control)

Other: Supportive Treatment for SMI

Interventions

psychosocial intervention that combines elements of cognitive-behavioral therapy (CBT) with work-related social skills training and basic problem solving training (SST)

Also known as: M-PROVE
Arm 1: MPROVE

Sessions are interactive, supportive, flexible, and unstructured, and are intended to help patients adjust to their new jobs and understand how working affects their lives. The therapist stance is non-directive, and there is an emphasis on having patients share with one another, rather than having the therapists dictate the content of group sessions. The primary goals of the therapists are to engage patients in treatment and to generate discussion among members.

Also known as: STS
Arm 2: Control

Eligibility Criteria

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

You may qualify if:

  • Diagnosis of schizophrenia or schizoaffective disorder, or other severe mental disorder including bipolar disorder, major depression, or severe anxiety disorder
  • Enrolled in vocational rehabilitation program or working
  • Age between 18 and 65 years
  • Ability and willingness to attend treatment sessions for 3 months
  • Judged by their treating clinician to be able to participate and provide informed consent
  • Ability and willingness to provide informed consent to participate

You may not qualify if:

  • Documented history of severe neurological disorder or head trauma with ongoing cognitive sequelae
  • Inability to effectively participate in the baseline assessments due to intoxication or psychiatric symptoms on two successive appointments

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

Baltimore, Maryland, 21201, United States

Location

MeSH Terms

Conditions

Mental DisordersSchizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders

Results Point of Contact

Title
Wendy Tenhula, Ph.D.
Organization
VA Central Office

Study Officials

  • Wendy Tenhula, PhD

    Baltimore VA Medical Center VA Maryland Health Care System, Baltimore, MD

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 30, 2005

First Posted

January 4, 2006

Study Start

October 1, 2005

Primary Completion

October 1, 2009

Study Completion

October 1, 2009

Last Updated

June 17, 2016

Results First Posted

June 17, 2016

Record last verified: 2016-05

Locations