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Preventing Mid- and Later-Life Work Limitations

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01163890
First Posted: July 16, 2010
Last Update Posted: April 8, 2014
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
OptumHealth Behavioral Solutions
Information provided by (Responsible Party):
Tufts Medical Center
  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: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care

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 ]
  • Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module [ Time Frame: 4 months post-randomization ]

Secondary Outcome Measures:
  • Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9) [ Time Frame: 4 months post-randomization ]

Enrollment: 431
Study Start Date: September 2009
Study Completion Date: June 2013
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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   45 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Tufts Medical Center
ClinicalTrials.gov Identifier: NCT01163890     History of Changes
Other Study ID Numbers: 1R01AG033125-01A1 ( U.S. NIH Grant/Contract )
First Submitted: July 14, 2010
First Posted: July 16, 2010
Last Update Posted: April 8, 2014
Last Verified: April 2014

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