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
  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:


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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 July 20, 2014