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Preventing Mid- and Later-Life Work Limitations

Primary Purpose

Depression

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Work and Health Initiative
Usual Medical or Behavioral Intervention
Sponsored by
Tufts Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional supportive care trial for Depression focused on measuring Depression, Work Performance and Productivity, Worksite Intervention

Eligibility Criteria

45 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Tufts Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

WHI

Usual Care

Arm Description

Outcomes

Primary Outcome Measures

At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire
Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module

Secondary Outcome Measures

Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9)

Full Information

First Posted
July 14, 2010
Last Updated
April 7, 2014
Sponsor
Tufts Medical Center
Collaborators
OptumHealth Behavioral Solutions
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1. Study Identification

Unique Protocol Identification Number
NCT01163890
Brief Title
Preventing Mid- and Later-Life Work Limitations
Official Title
Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care
Study Type
Interventional

2. Study Status

Record Verification Date
April 2014
Overall Recruitment Status
Completed
Study Start Date
September 2009 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
June 2013 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tufts Medical Center
Collaborators
OptumHealth Behavioral Solutions

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depression, Work Performance and Productivity, Worksite Intervention

7. Study Design

Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
431 (Actual)

8. Arms, Groups, and Interventions

Arm Title
WHI
Arm Type
Experimental
Arm Title
Usual Care
Arm Type
Active Comparator
Intervention Type
Behavioral
Intervention Name(s)
Work and Health Initiative
Intervention Description
Telephone-based multi-modal intervention, consisting of: vocational coaching, cognitive-behavioral therapy strategies and care coordination strategies provided by specially-trained EAP counselors
Intervention Type
Behavioral
Intervention Name(s)
Usual Medical or Behavioral Intervention
Intervention Description
Referral to treatment as usual through personal physician, mental health professional, behavioral health program, and/or Employee Assistance Program
Primary Outcome Measure Information:
Title
At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire
Time Frame
4 months post-randomization
Title
Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module
Time Frame
4 months post-randomization
Secondary Outcome Measure Information:
Title
Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
Time Frame
4 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Debra Lerner, MS, PhD
Organizational Affiliation
Tufts Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
Tufts Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
25892151
Citation
Adler DA, Lerner D, Visco ZL, Greenhill A, Chang H, Cymerman E, Azocar F, Rogers WH. Improving work outcomes of dysthymia (persistent depressive disorder) in an employed population. Gen Hosp Psychiatry. 2015 Jul-Aug;37(4):352-9. doi: 10.1016/j.genhosppsych.2015.04.001. Epub 2015 Apr 8.
Results Reference
derived

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Preventing Mid- and Later-Life Work Limitations

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