NCT01163890

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
431

participants targeted

Target at P75+ for not_applicable depression

Timeline
Completed

Started Sep 2009

Longer than P75 for not_applicable depression

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2009

Completed
11 months until next milestone

First Submitted

Initial submission to the registry

July 14, 2010

Completed
2 days until next milestone

First Posted

Study publicly available on registry

July 16, 2010

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
Last Updated

April 8, 2014

Status Verified

April 1, 2014

Enrollment Period

3.7 years

First QC Date

July 14, 2010

Last Update Submit

April 7, 2014

Conditions

Keywords

DepressionWork Performance and ProductivityWorksite Intervention

Outcome Measures

Primary Outcomes (2)

  • At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire

    4 months post-randomization

  • Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module

    4 months post-randomization

Secondary Outcomes (1)

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

    4 months post-randomization

Study Arms (2)

WHI

EXPERIMENTAL
Behavioral: Work and Health Initiative

Usual Care

ACTIVE COMPARATOR
Behavioral: Usual Medical or Behavioral Intervention

Interventions

Telephone-based multi-modal intervention, consisting of: vocational coaching, cognitive-behavioral therapy strategies and care coordination strategies provided by specially-trained EAP counselors

WHI

Referral to treatment as usual through personal physician, mental health professional, behavioral health program, and/or Employee Assistance Program

Usual Care

Eligibility Criteria

Age45 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tufts Medical Center

Boston, Massachusetts, 02111, United States

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Depression

Interventions

Behavior Therapy

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

PsychotherapyBehavioral Disciplines and Activities

Study Officials

  • Debra Lerner, MS, PhD

    Tufts Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 14, 2010

First Posted

July 16, 2010

Study Start

September 1, 2009

Primary Completion

May 1, 2013

Study Completion

June 1, 2013

Last Updated

April 8, 2014

Record last verified: 2014-04

Locations