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

About this trial
This is an interventional treatment trial for Depression focused on measuring Depressive disorder, Behavior therapy, Workplace, Subthreshold depression
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
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
NCT ID
NCT00885014
First Posted
April 20, 2009
Last Updated
March 15, 2012
Sponsor
Kyoto University
Collaborators
Nagoya City University
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
Learn more about this trial
Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace
We'll reach out to this number within 24 hrs