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

NCT ID: NCT00885014

Last Updated: 2012-03-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

PHASE2/PHASE3

Total Enrollment

118 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-04-30

Study Completion Date

2011-09-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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)).

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Depression

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

CBT

Telephone cognitive-behavioral therapy

Group Type EXPERIMENTAL

CBT

Intervention Type BEHAVIORAL

Telephone cognitive-behavioral therapy

EAP

Intervention Type BEHAVIORAL

Employees Assistance Program

TAU

Treatment as usual through the Employees Assistance Program

Group Type ACTIVE_COMPARATOR

EAP

Intervention Type BEHAVIORAL

Employees Assistance Program

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

CBT

Telephone cognitive-behavioral therapy

Intervention Type BEHAVIORAL

EAP

Employees Assistance Program

Intervention Type BEHAVIORAL

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

20 Years

Maximum Eligible Age

57 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Nagoya City University

OTHER

Sponsor Role collaborator

Kyoto University

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Toshiaki A. Furukawa

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Toshiaki Furukawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nagoya City University

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Nagoya City University

Nagoya, Aichi-ken, Japan

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Japan

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 26602093 (View on PubMed)

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.

Reference Type DERIVED
PMID: 22532849 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

NCUPsychiatry002

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

Treatment of Post-TBI Depression
NCT00211835 COMPLETED NA