Preventing Mid- and Later-Life Work Limitations

April 7, 2014 updated by: Tufts Medical Center

Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care

The Work and Health Initiative (WHI) trial is testing an innovative, community-based program that provides mental health and vocational services to workers 50 years or older to improve functioning and reduce productivity loss. The purpose of this study is to test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression and reduces depression-related productivity loss.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

National demographic, economic and cultural trends are creating a need for hiring and retaining older workers. However, while many older people will prefer and/or need to work, chronic health problems occurring in mid-life or later can severely disrupt employment. This study will conduct a randomized controlled trial (RCT) of the Work and Health Initiative (WHI). The WHI is an innovative community-based program that provides mental health and vocational services to workers with depression to improve functioning and reduce productivity loss. This study will focus on workers 50 years of age and older. This study will test the hypothesis that relative to usual care, the WHI improves the work outcomes of depression. Study results potentially will result in a new multi-disciplinary method for addressing a serious public health and employment issue.

Study Type

Interventional

Enrollment (Actual)

431

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02111
        • Tufts Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

45 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • age ≥ 45 years
  • working ≥ 15 hours/week
  • DSM-IV current major depression and/or dysthymia
  • Work limitations: at-work productivity loss score ≥ 5%

Exclusion Criteria:

  • severe physical health deficits
  • non-English speaking or reading
  • positive current alcoholism screening
  • psychosis
  • mania

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Usual Care
Behavioral: Usual Medical or Behavioral Intervention
Referral to treatment as usual through personal physician, mental health professional, behavioral health program, and/or Employee Assistance Program
Experimental: WHI
Behavioral: Work and Health Initiative
Telephone-based multi-modal intervention, consisting of: vocational coaching, cognitive-behavioral therapy strategies and care coordination strategies provided by specially-trained EAP counselors

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire
Time Frame: 4 months post-randomization
4 months post-randomization
Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module
Time Frame: 4 months post-randomization
4 months post-randomization

Secondary Outcome Measures

Outcome Measure
Time Frame
Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
Time Frame: 4 months post-randomization
4 months post-randomization

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tufts Medical Center

Collaborators

OptumHealth Behavioral Solutions

Investigators

  • Principal Investigator: Debra Lerner, MS, PhD, Tufts Medical Center

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

June 1, 2013

Study Registration Dates

First Submitted

July 14, 2010

First Submitted That Met QC Criteria

July 14, 2010

First Posted (Estimate)

July 16, 2010

Study Record Updates

Last Update Posted (Estimate)

April 8, 2014

Last Update Submitted That Met QC Criteria

April 7, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1R01AG033125-01A1 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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