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

This study has been completed.
Sponsor:
Collaborator:
Nagoya City University
Information provided by (Responsible Party):
Toshiaki A. Furukawa, Kyoto University
ClinicalTrials.gov Identifier:
NCT00885014
First received: April 20, 2009
Last updated: March 15, 2012
Last verified: March 2012
History of Changes
  Purpose

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)).


Condition Intervention Phase
Depression
 Behavioral: CBT
Behavioral: EAP
 Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial

Resource links provided by NLM:

MedlinePlus related topics: Depression
U.S. FDA Resources

Further study details as provided by Kyoto University:

Primary Outcome Measures:
  • Depression severity as measured by Beck Depression Inventory-II (BDI2) [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Depression severity as measured by Kessler Scale (K6) [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]
  • Client satisfaction as measured by Visual Analogue Scale (VAS) [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]
  • Depression severity as measured by BDI2 and K6 [ Time Frame: 15 months post-randomization ] [ Designated as safety issue: No ]
  • Work performance as measured by HPQ and by job retention [ Time Frame: 15 months post-randomization ] [ Designated as safety issue: No ]
  • Client satisfaction as measured by VAS [ Time Frame: 15 months post-randomization ] [ Designated as safety issue: No ]
  • Use of EAP services and other health services [ Time Frame: 15 months post-randomization ] [ Designated as safety issue: No ]
  • Suicidal attempt and/or hospitalization (physical or mental) [ Time Frame: 15 months post-randomization ] [ Designated as safety issue: Yes ]
  • Time to incident major or minor depressive episode [ Time Frame: 15 months post-randomization ] [ Designated as safety issue: No ]

Enrollment: 118
Study Start Date: April 2009
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: CBT
Telephone cognitive-behavioral therapy
 Behavioral: CBT
Telephone cognitive-behavioral therapy
Behavioral: EAP
Employees Assistance Program
Active Comparator: TAU
Treatment as usual through the Employees Assistance Program
 Behavioral: EAP
Employees Assistance Program

  Eligibility

Ages Eligible for Study:   20 Years to 57 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00885014

Locations
Japan
Nagoya City University
Nagoya, Aichi, Japan, 467-8601
Sponsors and Collaborators
Kyoto University
Nagoya City University
Investigators
Principal Investigator: Toshiaki Furukawa, MD, PhD Nagoya City University
  More Information

No publications provided by Kyoto University

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Toshiaki A. Furukawa, Professor, Kyoto University
ClinicalTrials.gov Identifier: NCT00885014     History of Changes
Other Study ID Numbers: NCUPsychiatry002
Study First Received: April 20, 2009
Last Updated: March 15, 2012
Health Authority: Japan: Institutional Review Board

Keywords provided by Kyoto University:
Depressive disorder
Behavior therapy
Workplace
Subthreshold depression

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on June 17, 2013