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Completed

NCT Number: NCT00885014

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

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)).

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Key information

Conditions

Depression Behavior Behavioral Symptoms Depressive Disorder Mental Disorders Mood Disorders

Age range

20 year–57 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2 / Phase 3

Primary location

Nagoya City University

Nagoya, Aichi-ken, 467-8601, Japan

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CBT

Behavioral

Telephone cognitive-behavioral therapy

EAP

Behavioral

Employees Assistance Program

Primary outcomes

  1. Depression severity as measured by Beck Depression Inventory-II (BDI2)

    Time frame: 4 months post-randomization

  2. 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 outcomes

  1. Depression severity as measured by Kessler Scale (K6)

    Time frame: 4 months post-randomization

  2. Client satisfaction as measured by Visual Analogue Scale (VAS)

    Time frame: 4 months post-randomization

  3. Depression severity as measured by BDI2 and K6

    Time frame: 15 months post-randomization

  4. Work performance as measured by HPQ and by job retention

    Time frame: 15 months post-randomization

  5. Client satisfaction as measured by VAS

    Time frame: 15 months post-randomization

  6. Use of EAP services and other health services

    Time frame: 15 months post-randomization

  7. Suicidal attempt and/or hospitalization (physical or mental)

    Time frame: 15 months post-randomization

  8. Time to incident major or minor depressive episode

    Time frame: 15 months post-randomization

Sponsors and collaborators

Lead sponsor

Kyoto University

Other

Collaborators

  • Nagoya City University

Registry information

Official study title

Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Apr 21, 2009
Registry last updated
Mar 19, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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