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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00057590
Other study ID # R01MH061941
Secondary ID R01MH061941DSIR
Status Completed
Phase N/A
First received April 4, 2003
Last updated May 3, 2013
Start date March 2003

Study information

Verified date May 2013
Source Harvard Medical School
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

This study will assess the effects of depression treatment on employee productivity. This study will also evaluate the impact of depression screening and outreach on employees' receptivity to treatment.


Description:

This study is conducted in three phases. In the first phase, employees from various companies participate in an on-line Health Risk Assessment survey at a secure website. Those who display symptoms of depression participate in a brief telephone interview to confirm the depression diagnosis.

In the second phase, depressed participants are randomly assigned to receive either intervention treatment or usual care for 18 months. The intervention consists of periodic telephone contact with a mental health clinician who provides education regarding depression and its treatment. Participants receiving the intervention are also provided with resources to obtain psychotherapy and/or pharmacotherapy. Those who do not seek treatment are monitored and supported. Participants in the usual care arm are informed of their possible depression and are encouraged to seek professional treatment.

The final phase of the study involves data analysis and dissemination of aggregated results. Surveys and questionnaires are used to assess participants.


Recruitment information / eligibility

Status Completed
Enrollment 590
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 18 Years and older
Eligibility Inclusion Criteria:

- Major depressive episode

- Employed

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Care manager outreach and monitoring


Locations

Country Name City State
United States Harvard Medical School Boston Massachusetts

Sponsors (2)

Lead Sponsor Collaborator
Harvard Medical School National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

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