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

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

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00885014
Enrollment
118
Registered
2009-04-21
Start date
2009-04-30
Completion date
2011-09-30
Last updated
2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Depression

Keywords

Depressive disorder, Behavior therapy, Workplace, Subthreshold depression

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)).

Interventions

BEHAVIORALCBT

Telephone cognitive-behavioral therapy

BEHAVIORALEAP

Employees Assistance Program

Sponsors

Nagoya City University
CollaboratorOTHER
Kyoto University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
20 Years to 57 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
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 month4 months post-randomization

Secondary

MeasureTime frame
Depression severity as measured by BDI2 and K615 months post-randomization
Work performance as measured by HPQ and by job retention15 months post-randomization
Client satisfaction as measured by VAS15 months post-randomization
Depression severity as measured by Kessler Scale (K6)4 months post-randomization
Suicidal attempt and/or hospitalization (physical or mental)15 months post-randomization
Time to incident major or minor depressive episode15 months post-randomization
Use of EAP services and other health services15 months post-randomization
Client satisfaction as measured by Visual Analogue Scale (VAS)4 months post-randomization

Countries

Japan

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 26, 2026