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Preventing Mid- and Later-Life Work Limitations

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
OptumHealth Behavioral Solutions
Information provided by (Responsible Party):
Tufts Medical Center
ClinicalTrials.gov Identifier:
NCT01163890
First received: July 14, 2010
Last updated: January 3, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition Intervention
Depression
 Behavioral: Work and Health Initiative
Behavioral: Usual Medical or Behavioral Intervention

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Tufts Medical Center:

Primary Outcome Measures:
  • At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]
  • Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9) [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]

Estimated Enrollment: 500
Study Start Date: September 2009
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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
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

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.

  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01163890

Locations
United States, Massachusetts
Tufts Medical Center
Boston, Massachusetts, United States, 02111
Sponsors and Collaborators
Tufts Medical Center
OptumHealth Behavioral Solutions
Investigators
Principal Investigator: Debra Lerner, MS, PhD Tufts Medical Center
  More Information

Additional Information:
WHI Study Website  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01163890     History of Changes
Other Study ID Numbers: 1R01AG033125-01A1
Study First Received: July 14, 2010
Last Updated: January 3, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Tufts Medical Center:
Depression
Work Performance and Productivity
Worksite Intervention

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on May 16, 2013