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)).

Study Overview

• Status: Completed
• Conditions: Depression
• Intervention / Treatment: Behavioral: CBT; Behavioral: EAP

• Study Type: Interventional
• Enrollment (Actual): 118
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 467-8601
      • Nagoya City University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 57 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Depression severity as measured by Beck Depression Inventory-II (BDI2)	4 months post-randomization
Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month	4 months post-randomization

Secondary Outcome Measures

Outcome Measure	Time Frame
Depression severity as measured by Kessler Scale (K6)	4 months post-randomization
Client satisfaction as measured by Visual Analogue Scale (VAS)	4 months post-randomization
Depression severity as measured by BDI2 and K6	15 months post-randomization
Work performance as measured by HPQ and by job retention	15 months post-randomization
Client satisfaction as measured by VAS	15 months post-randomization
Use of EAP services and other health services	15 months post-randomization
Suicidal attempt and/or hospitalization (physical or mental)	15 months post-randomization
Time to incident major or minor depressive episode	15 months post-randomization

Collaborators and Investigators

• Sponsor: Kyoto University
• Collaborators: Nagoya City University
• Investigators: Principal Investigator: Toshiaki Furukawa, MD, PhD, Nagoya City University

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: April 1, 2009
• Primary Completion (Actual): April 1, 2011
• Study Completion (Actual): September 1, 2011

Study Registration Dates

• First Submitted: April 20, 2009
• First Submitted That Met QC Criteria: April 20, 2009
• First Posted (Estimate): April 21, 2009

Study Record Updates

• Last Update Posted (Estimate): March 19, 2012
• Last Update Submitted That Met QC Criteria: March 15, 2012
• Last Verified: March 1, 2012

More Information

Terms related to this study

• Keywords: Workplace; Depressive disorder; Behavior therapy; Subthreshold depression
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: NCUPsychiatry002