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

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ClinicalTrials.gov Identifier: NCT00885014
Recruitment Status : Completed
First Posted : April 21, 2009
Last Update Posted : March 19, 2012
Sponsor:
Collaborator:
Nagoya City University
Information provided by (Responsible Party):
Toshiaki A. Furukawa, Kyoto University

Tracking Information
First Submitted Date  ICMJE April 20, 2009
First Posted Date  ICMJE April 21, 2009
Last Update Posted Date March 19, 2012
Study Start Date  ICMJE April 2009
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2010)
  • Depression severity as measured by Beck Depression Inventory-II (BDI2) [ Time Frame: 4 months post-randomization ]
  • 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 ]
Original Primary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
  • Depression severity as measured by BDI2 [ Time Frame: 4 months post-randomization ]
  • Work performance as measured by the HPQ "effective hours worked" for the past month [ Time Frame: 4 months post-randomization ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 9, 2010)
  • Depression severity as measured by Kessler Scale (K6) [ Time Frame: 4 months post-randomization ]
  • Client satisfaction as measured by Visual Analogue Scale (VAS) [ Time Frame: 4 months post-randomization ]
  • Depression severity as measured by BDI2 and K6 [ Time Frame: 15 months post-randomization ]
  • Work performance as measured by HPQ and by job retention [ Time Frame: 15 months post-randomization ]
  • Client satisfaction as measured by VAS [ Time Frame: 15 months post-randomization ]
  • Use of EAP services and other health services [ Time Frame: 15 months post-randomization ]
  • Suicidal attempt and/or hospitalization (physical or mental) [ Time Frame: 15 months post-randomization ]
  • Time to incident major or minor depressive episode [ Time Frame: 15 months post-randomization ]
Original Secondary Outcome Measures  ICMJE
 (submitted: April 20, 2009)
  • Depression severity as measured by K6 [ Time Frame: 4 months post-randomization ]
  • Client satisfaction as measured by VAS [ Time Frame: 4 months post-randomization ]
  • Depression severity as measured by BDI2 and K6 [ Time Frame: 15 months post-randomization ]
  • Work performance as measured by HPQ and by job retention [ Time Frame: 15 months post-randomization ]
  • Client satisfaction as measured by VAS [ Time Frame: 15 months post-randomization ]
  • Use of EAP services and other health services [ Time Frame: 15 months post-randomization ]
  • Suicidal attempt and/or hospitalization (physical or mental) [ Time Frame: 15 months post-randomization ]
  • Time to incident major or minor depressive episode [ Time Frame: 15 months post-randomization ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace
Official Title  ICMJE Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
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 Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Depression
Intervention  ICMJE
  • Behavioral: CBT
    Telephone cognitive-behavioral therapy
  • Behavioral: EAP
    Employees Assistance Program
Study Arms  ICMJE
  • Experimental: CBT
    Telephone cognitive-behavioral therapy
    Interventions:
    • Behavioral: CBT
    • Behavioral: EAP
  • Active Comparator: TAU
    Treatment as usual through the Employees Assistance Program
    Intervention: Behavioral: EAP
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: March 15, 2012)
118
Original Estimated Enrollment  ICMJE
 (submitted: April 20, 2009)
98
Actual Study Completion Date  ICMJE September 2011
Actual Primary Completion Date April 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 20 Years to 57 Years   (Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Japan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00885014
Other Study ID Numbers  ICMJE NCUPsychiatry002
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Toshiaki A. Furukawa, Kyoto University
Study Sponsor  ICMJE Kyoto University
Collaborators  ICMJE Nagoya City University
Investigators  ICMJE
Principal Investigator: Toshiaki Furukawa, MD, PhD Nagoya City University
PRS Account Kyoto University
Verification Date March 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP