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

Depression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00885014
• Other study ID #: NCUPsychiatry002
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: April 20, 2009
• Last updated: March 15, 2012
• Start date: April 2009
• Est. completion date: September 2011

Study information

• Verified date: March 2012
• Source: Kyoto University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Institutional Review Board
• Study type: Interventional

Clinical Trial 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)).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 118
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 57 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Depression
• Depressive Disorder

Intervention

Behavioral:
• CBT
Telephone cognitive-behavioral therapy
• EAP
Employees Assistance Program

Locations

Country	Name	City	State
Japan	Nagoya City University	Nagoya	Aichi

Sponsors (2)

Lead Sponsor	Collaborator
Kyoto University	Nagoya City University

Country where clinical trial is conducted

Japan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depression severity as measured by Beck Depression Inventory-II (BDI2)		4 months post-randomization	No
Primary	Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month		4 months post-randomization	No
Secondary	Depression severity as measured by Kessler Scale (K6)		4 months post-randomization	No
Secondary	Client satisfaction as measured by Visual Analogue Scale (VAS)		4 months post-randomization	No
Secondary	Depression severity as measured by BDI2 and K6		15 months post-randomization	No
Secondary	Work performance as measured by HPQ and by job retention		15 months post-randomization	No
Secondary	Client satisfaction as measured by VAS		15 months post-randomization	No
Secondary	Use of EAP services and other health services		15 months post-randomization	No
Secondary	Suicidal attempt and/or hospitalization (physical or mental)		15 months post-randomization	Yes
Secondary	Time to incident major or minor depressive episode		15 months post-randomization	No