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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

Study Description
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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)).

Condition or disease Intervention/treatment Phase
Depression Behavioral: CBT Behavioral: EAP Phase 2 Phase 3

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 118 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
Study Start Date : April 2009
Actual Primary Completion Date : April 2011
Actual Study Completion Date : September 2011

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Arms and Interventions
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Depression severity as measured by Beck Depression Inventory-II (BDI2) [ Time Frame: 4 months post-randomization ]
  2. 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 ]

Secondary Outcome Measures :
  1. Depression severity as measured by Kessler Scale (K6) [ Time Frame: 4 months post-randomization ]
  2. Client satisfaction as measured by Visual Analogue Scale (VAS) [ Time Frame: 4 months post-randomization ]
  3. Depression severity as measured by BDI2 and K6 [ Time Frame: 15 months post-randomization ]
  4. Work performance as measured by HPQ and by job retention [ Time Frame: 15 months post-randomization ]
  5. Client satisfaction as measured by VAS [ Time Frame: 15 months post-randomization ]
  6. Use of EAP services and other health services [ Time Frame: 15 months post-randomization ]
  7. Suicidal attempt and/or hospitalization (physical or mental) [ Time Frame: 15 months post-randomization ]
  8. Time to incident major or minor depressive episode [ Time Frame: 15 months post-randomization ]

Eligibility Criteria
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Ages Eligible for Study:   20 Years to 57 Years   (Adult)
Sexes Eligible for Study:   All
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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
First Posted: April 21, 2009    Key Record Dates
Last Update Posted: March 19, 2012
Last Verified: March 2012

Keywords provided by Toshiaki A. Furukawa, Kyoto University:
Depressive disorder
Behavior therapy
Workplace
Subthreshold depression

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