Automated Assessment of Mental Health in the Workplace | NCT00134576

Studies
Automated Assessment of Mental Health in the Workplace

NCT00134576

Sponsor

Boston Medical Center

Status

Completed

Last Update Posted

Jun 3, 2010Estimated

Enrollment

150Estimated

Phase

Not Applicable

Conditions

Mental Disorders

Interventions

Computer Assisted Education for Behavioral Change

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

Status Module

Record Verification Date

May 2010

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

May 2007

Primary Completion Date

Sep 2008Actual

Completion Date

Jan 2009Actual

First Submitted Date

Aug 23, 2005

First Submission Date that Met QC Criteria

Aug 24, 2005

First Posted Date

Aug 25, 2005Estimated

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 1, 2010

Last Update Posted Date

Jun 3, 2010Estimated

Name	Class
Centers for Disease Control and Prevention	FED

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

The purpose of this study is to design, refine, and test for the effectiveness of a computer-based telephone system (Telephone-Linked Communications for Detection of Mental Health Disorders in the Workplace; TLC-Detect) that will screen workers for mental health distress; educate them about seeking treatment; and follow up with them over a 6 month period.

Detailed Description

Not provided

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

150Estimated

Arms/Interventions Module

Arm Groups

Not provided

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Computer Assisted Education for Behavioral Change	Behavioral	TLC-Detect will provide subjects in the intervention group with information about each diagnosed mental health disorder. TLC-Detect will then give the Treatment Module and will tell the intervention subjects that it will call back in one month for a follow-up or the next week if a subject is comorbid with other disorders.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Absenteeism and presentism (functionality at work), measured every three months for 6 months		6 months

Secondary Outcomes

Measure	Description	Time Frame
Treatment status, timing of measurement depends upon symptom severity		6 months
Health status measured every three months for 6 months		6 months

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Employment with benefits at Boston Medical Center, Boston University, or Florida Power and Light Company
Ability to speak and understand conversational English
> 18 years of age
Access to a touch-tone telephone
Screen positive for the World Health Organization (WHO)-5 Well-Being Index

Exclusion Criteria:

Being under treatment (medication or therapy) for a mental health disorder
Taking medication for a serious/major medical disorder that interferes with normal life
Taking medication prescribed for mental health treatment on a daily basis
Diagnosed with schizophrenia
Planning to go on leave for over 6 months

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ramesh Farzanfar, PhD	Boston University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Boston Medical Center		Boston	Massachusetts	02118	United States

Condition Browse Module

MeSH Terms

ID	Term
D001523	Mental Disorders

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided