Clinical trial NCT01163890: Preventing Mid- and Later-Life Work Limitations
Official title: Preventing Mid- and Later-Life Work Limitations: Community-Based Depression Care
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Depression
Keywords: Depression
Work Performance and Productivity
Worksite Intervention
Lead sponsor: Tufts Medical Center
Sponsor class: OTHER
Collaborators: name: OptumHealth Behavioral Solutions
First posted: 2010-07-16
Enrollment: 431
Sex: ALL
Minimum age (years): 45
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: At-work performance deficits and productivity loss as measured by the Work Limitations Questionnaire
timeFrame: 4 months post-randomization
measure: Absenteeism and productivity loss as measured by the Work Limitations Questionnaire Absence Module
timeFrame: 4 months post-randomization
Secondary outcomes:
measure: Depression symptom severity as measured by the Patient Health Questionnaire (PHQ-9)
timeFrame: 4 months post-randomization
Other outcomes:
Locations:
city: Boston
country: United States
facility: Tufts Medical Center
state: Massachusetts
Study officials:
affiliation: Tufts Medical Center
name: Debra Lerner, MS, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.