Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial

Kyoto University1 site in 1 country118 target enrollmentApril 2009

ConditionsDepression

Overview

Phase: Phase 2
Intervention: Not specified
Conditions: Depression
Sponsor: Kyoto University
Enrollment: 118
Locations: 1
Primary Endpoint: Depression severity as measured by Beck Depression Inventory-II (BDI2)
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The purpose of the study is to examine the effectiveness of telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace, in comparison with treatment-as-usual (TAU) (which is minimal contact through Employers Assistance Program (EAP)).

Registry

clinicaltrials.gov

Start Date

April 2009

End Date

September 2011

Last Updated

14 years ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

Kyoto University

Responsible Party

Principal Investigator

Toshiaki A. Furukawa

Professor

Kyoto University

Eligibility Criteria

Inclusion Criteria

•Age 20-57 at study entry \[because the retirement age is usually 60, we have to recruit the patients well before 60 in order to allow time for follow-up\]
•Men and women
•Currently employed full-time (either regular or temporary) by the business company
•Expected to be employed full-time for 2 years after screening
•K6 scores greater than or equal to 9 (or 10) at screening
•BDI2 scores greater than or equal to 10 at 2nd screening (Composite International Diagnostic Interview (CIDI) interview)

Exclusion Criteria

•Part-time employees
•Sick leave for 6 or more days for a physical or mental condition in the past month
•Expected to be on pregnancy leave, maternity leave or nursing leave within 2 years after screening
•Current treatment for a mental health problem from a mental health professional
•Major depressive episode in the past month, as ascertained by CIDI \[We do not exclude dysthymia or major depression in partial remission\]
•Lifetime history of bipolar disorder, as ascertained by CIDI
•Any substance dependence in the past 12 months, as ascertained by CIDI. \[We do not exclude substance abuse.\]
•Any other current mental disorder if it constitutes the predominant aspect of the clinical presentation and requires treatment not offered in the project
•Those who have already received the telephone CBT in the pilot runs

Outcomes

Primary Outcomes

Depression severity as measured by Beck Depression Inventory-II (BDI2)

Time Frame: 4 months post-randomization

Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month

Time Frame: 4 months post-randomization

Secondary Outcomes

Client satisfaction as measured by Visual Analogue Scale (VAS)(4 months post-randomization)
Depression severity as measured by Kessler Scale (K6)(4 months post-randomization)
Depression severity as measured by BDI2 and K6(15 months post-randomization)
Work performance as measured by HPQ and by job retention(15 months post-randomization)
Client satisfaction as measured by VAS(15 months post-randomization)
Use of EAP services and other health services(15 months post-randomization)
Suicidal attempt and/or hospitalization (physical or mental)(15 months post-randomization)
Time to incident major or minor depressive episode(15 months post-randomization)