NCT00885014

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)).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
118

participants targeted

Target at P50-P75 for phase_2 depression

Timeline
Completed

Started Apr 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2009

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

April 20, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

April 21, 2009

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

March 19, 2012

Status Verified

March 1, 2012

Enrollment Period

2 years

First QC Date

April 20, 2009

Last Update Submit

March 15, 2012

Conditions

Depression

Keywords

Depressive disorderBehavior therapyWorkplaceSubthreshold depression

Outcome Measures

Primary Outcomes (2)

  • 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 Outcomes (8)

  • 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

  • +3 more secondary outcomes

Study Arms (2)

CBT

EXPERIMENTAL

Telephone cognitive-behavioral therapy

Behavioral: CBTBehavioral: EAP

TAU

ACTIVE COMPARATOR

Treatment as usual through the Employees Assistance Program

Behavioral: EAP

Interventions

CBTBEHAVIORAL

Telephone cognitive-behavioral therapy

CBT
EAPBEHAVIORAL

Employees Assistance Program

CBTTAU

Eligibility Criteria

Age20 Years - 57 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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)

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nagoya City University

Nagoya, Aichi-ken, 467-8601, Japan

Location

Related Publications (2)

  • 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.

    PMID: 26602093DERIVED

  • 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.

    PMID: 22532849DERIVED

MeSH Terms

Conditions

DepressionDepressive Disorder

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMood DisordersMental Disorders

Study Officials

  • Toshiaki Furukawa, MD, PhD

    Nagoya City University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 20, 2009

First Posted

April 21, 2009

Study Start

April 1, 2009

Primary Completion

April 1, 2011

Study Completion

September 1, 2011

Last Updated

March 19, 2012

Record last verified: 2012-03

Locations

JP(1)