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

Primary Purpose

Depression

Status
Completed
Phase
Phase 2
Locations
Japan
Study Type
Interventional
Intervention
CBT
EAP
Sponsored by
Kyoto University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression focused on measuring Depressive disorder, Behavior therapy, Workplace, Subthreshold depression

Eligibility Criteria

20 Years - 57 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Nagoya City University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

CBT

TAU

Arm Description

Telephone cognitive-behavioral therapy

Treatment as usual through the Employees Assistance Program

Outcomes

Primary Outcome Measures

Depression severity as measured by Beck Depression Inventory-II (BDI2)
Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month

Secondary Outcome Measures

Depression severity as measured by Kessler Scale (K6)
Client satisfaction as measured by Visual Analogue Scale (VAS)
Depression severity as measured by BDI2 and K6
Work performance as measured by HPQ and by job retention
Client satisfaction as measured by VAS
Use of EAP services and other health services
Suicidal attempt and/or hospitalization (physical or mental)
Time to incident major or minor depressive episode

Full Information

First Posted
April 20, 2009
Last Updated
March 15, 2012
Sponsor
Kyoto University
Collaborators
Nagoya City University
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1. Study Identification

Unique Protocol Identification Number
NCT00885014
Brief Title
Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace
Official Title
Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
March 2012
Overall Recruitment Status
Completed
Study Start Date
April 2009 (undefined)
Primary Completion Date
April 2011 (Actual)
Study Completion Date
September 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kyoto University
Collaborators
Nagoya City University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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)).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression
Keywords
Depressive disorder, Behavior therapy, Workplace, Subthreshold depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
118 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT
Arm Type
Experimental
Arm Description
Telephone cognitive-behavioral therapy
Arm Title
TAU
Arm Type
Active Comparator
Arm Description
Treatment as usual through the Employees Assistance Program
Intervention Type
Behavioral
Intervention Name(s)
CBT
Intervention Description
Telephone cognitive-behavioral therapy
Intervention Type
Behavioral
Intervention Name(s)
EAP
Intervention Description
Employees Assistance Program
Primary Outcome Measure Information:
Title
Depression severity as measured by Beck Depression Inventory-II (BDI2)
Time Frame
4 months post-randomization
Title
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 Measure Information:
Title
Depression severity as measured by Kessler Scale (K6)
Time Frame
4 months post-randomization
Title
Client satisfaction as measured by Visual Analogue Scale (VAS)
Time Frame
4 months post-randomization
Title
Depression severity as measured by BDI2 and K6
Time Frame
15 months post-randomization
Title
Work performance as measured by HPQ and by job retention
Time Frame
15 months post-randomization
Title
Client satisfaction as measured by VAS
Time Frame
15 months post-randomization
Title
Use of EAP services and other health services
Time Frame
15 months post-randomization
Title
Suicidal attempt and/or hospitalization (physical or mental)
Time Frame
15 months post-randomization
Title
Time to incident major or minor depressive episode
Time Frame
15 months post-randomization

10. Eligibility

Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
57 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Toshiaki Furukawa, MD, PhD
Organizational Affiliation
Nagoya City University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Nagoya City University
City
Nagoya
State/Province
Aichi
ZIP/Postal Code
467-8601
Country
Japan

12. IPD Sharing Statement

Citations:
PubMed Identifier
26602093
Citation
Hayasaka Y, Furukawa TA, Sozu T, Imai H, Kawakami N, Horikoshi M; GENKI Project. Enthusiasm for homework and improvement of psychological distress in subthreshold depression during behavior therapy: secondary analysis of data from a randomized controlled trial. BMC Psychiatry. 2015 Nov 25;15:302. doi: 10.1186/s12888-015-0687-3.
Results Reference
derived
PubMed Identifier
22532849
Citation
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.
Results Reference
derived

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

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