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

Kyoto University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Depression

Treatments: Behavioral: CBT; Behavioral: EAP

Study type: Interventional

Funder types: Other

Identifiers

NCT00885014

NCUPsychiatry002

Details and patient eligibility

About

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)).

Enrollment: 118 patients

Sex: All

Ages: 20 to 57 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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118 participants in 2 patient groups

CBT

Experimental group

Description:

Telephone cognitive-behavioral therapy

Treatment:

Behavioral: EAP

Behavioral: CBT

TAU

Active Comparator group

Description:

Treatment as usual through the Employees Assistance Program

Treatment:

Behavioral: EAP