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

April 20, 2009
March 15, 2012
April 2009
April 2011   (final data collection date for primary outcome measure)
  • 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 ]
  • Depression severity as measured by BDI2 [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]
  • Work performance as measured by the HPQ "effective hours worked" for the past month [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]
Complete list of historical versions of study NCT00885014 on ClinicalTrials.gov Archive Site
  • 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 ]
  • Depression severity as measured by K6 [ Time Frame: 4 months post-randomization ] [ Designated as safety issue: No ]
  • Client satisfaction as measured by 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 ]
Not Provided
Not Provided
 
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

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)).

Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Depression
  • Behavioral: CBT
    Telephone cognitive-behavioral therapy
  • Behavioral: EAP
    Employees Assistance Program
  • 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
Furukawa TA, Horikoshi M, Kawakami N, Kadota M, Sasaki M, Sekiya Y, Hosogoshi H, Kashimura M, Asano K, Terashima H, Iwasa K, Nagasaku M, Grothaus LC; GENKI Project. Telephone cognitive-behavioral therapy for subthreshold depression and presenteeism in workplace: a randomized controlled trial. PLoS One. 2012;7(4):e35330. doi: 10.1371/journal.pone.0035330. Epub 2012 Apr 19.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
118
September 2011
April 2011   (final data collection date for primary outcome measure)

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
Both
20 Years to 57 Years
No
Contact information is only displayed when the study is recruiting subjects
Japan
 
NCT00885014
NCUPsychiatry002
Yes
Toshiaki A. Furukawa, Kyoto University
Kyoto University
Nagoya City University
Principal Investigator: Toshiaki Furukawa, MD, PhD Nagoya City University
Kyoto University
March 2012

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