A Behavioral Intervention to Improve Work Outcomes | NCT00333658

Studies
A Behavioral Intervention to Improve Work Outcomes

NCT00333658

Sponsor

US Department of Veterans Affairs

Status

Completed

Last Update Posted

Jun 25, 2009Estimated

Enrollment

57Actual

Phase

Not Applicable

Conditions

Mental Disorders

Interventions

Goal setting and work feedback group

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

ID	Type	Description	Link
MDB0007

Status Module

Record Verification Date

Jun 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Dec 2003

Primary Completion Date

Oct 2007Actual

Completion Date

Sep 2008Actual

First Submitted Date

Jun 2, 2006

First Submission Date that Met QC Criteria

Jun 2, 2006

First Posted Date

Jun 6, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 24, 2009

Last Update Posted Date

Jun 25, 2009Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

US Department of Veterans AffairsFED

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

This research has been designed to learn whether getting regular and specific feedback about work performance with small rewards for meeting goals helps people to improve their job performance and leads to better work outcomes, improved mental functioning, and better quality of life

Detailed Description

This study is designed to test whether systematic work performance feedback with weekly goal setting, combined with small rewards given for goal achievement, leads to improved vocational, health, and quality of life outcomes for veterans enrolled in the various work service programs at this medical center. The long-term goal of this project is to determine the effectiveness of these interventions at this medical center and to use this experience for a multi-site cooperative study proposal.

Research Design and Methods: One hundred and fifty subjects accepted into work services at this medical center will be randomly assigned to one of two conditions: Work Feedback with Small Rewards, or Usual Services. In the Work Feedback with Small Rewards condition, participants attend a weekly workers meeting where they receive specific feedback based upon the Work Behavior Inventory and set weekly goals. They also receive small rewards for goal achievement that equal $10 per month. Participants in the Usual Services condition do not get specific work feedback but receive all the usual work services normally provided. They also receive $10 per month for active participation. Assessments include baseline evaluations of mental and physical health, social function, cognitive function, and quality of life. Evaluations of mental health, quality of life, and job satisfaction will occur at two months and four months. Six-month and twelve month evaluations will repeat the baseline assessment. Outcome measures will include biweekly work performance assessments, vocational outcomes, mental and physical health status, social and cognitive function, and quality of life

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

57Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
1	Experimental	Intervention	Behavioral: Goal setting and work feedback group
2	No Intervention	Work Services

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Goal setting and work feedback group	Behavioral	Goal setting and feedback using WBI	1

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Competitive employment-		6 month and 12 month follow-up

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Veterans participating in a work program at the VA Connecticut Healthcare System; English-speaking

Exclusion Criteria:

No exclusion criteria based upon diagnosis, although VA work programs have pre-existing requirements such as a demonstrated need for services, a referral from a clinician, and an interest in work rehabilitation

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Morris D Bell, PhD	VA Connecticut Health Care System (West Haven)	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
VA Connecticut Health Care System (West Haven)		West Haven	Connecticut	06516	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
11354594	Result	Bell MD, Bryson G. Work rehabilitation in schizophrenia: does cognitive impairment limit improvement? Schizophr Bull. 2001;27(2):269-79. doi: 10.1093/oxfordjournals.schbul.a006873.
12586961	Result	Bryson G, Bell MD. Initial and final work performance in schizophrenia: cognitive and symptom predictors. J Nerv Ment Dis. 2003 Feb;191(2):87-92. doi: 10.1097/01.NMD.0000050937.06332.3C.