Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace

Phase 2

Completed

• Conditions: Depression
• Interventions: Behavioral: EAP; Behavioral: CBT

• Registration Number: NCT00885014
• Lead Sponsor: Kyoto University

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)).

Detailed Description

Not available

Study Timeline

• Study Start: 2009-04
• Study First Submitted: 2009-04-20
• Study First Submitted QC: 2009-04-20
• Study First Posted: 2009-04-21
• Primary Completion: 2011-04
• Study Completion: 2011-09
• Status Verified: 2012-03
• Last Update Submitted: 2012-03-15
• Last Update Posted: 2012-03-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 118

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TAU	EAP	Treatment as usual through the Employees Assistance Program
CBT	CBT	Telephone cognitive-behavioral therapy
CBT	EAP	Telephone cognitive-behavioral therapy

Primary Outcome Measures

Name	Time	Method
Depression severity as measured by Beck Depression Inventory-II (BDI2)	4 months post-randomization
Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month	4 months post-randomization

Secondary Outcome Measures

Name	Time	Method
Depression severity as measured by Kessler Scale (K6)	4 months post-randomization
Client satisfaction as measured by Visual Analogue Scale (VAS)	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

Trial Locations

Locations (1)

Nagoya City University; 🇯🇵 Nagoya, Aichi, Japan