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

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

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 (Adult)
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

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

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.


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 September 29, 2016