Clinical trial NCT00885014: Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace
Official title: Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Depression
Keywords: Depressive disorder
Behavior therapy
Workplace
Subthreshold depression
Lead sponsor: Kyoto University Hospital
Sponsor class: OTHER
Collaborators: name: Nagoya City University
First posted: 2009-04-21
Enrollment: 118
Sex: ALL
Minimum age (years): 20
Maximum age (years): 57
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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)).


Eligibility 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

Primary outcomes:
measure: Depression severity as measured by Beck Depression Inventory-II (BDI2)
timeFrame: 4 months post-randomization
measure: Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month
timeFrame: 4 months post-randomization
Secondary outcomes:
measure: Depression severity as measured by Kessler Scale (K6)
timeFrame: 4 months post-randomization
measure: Client satisfaction as measured by Visual Analogue Scale (VAS)
timeFrame: 4 months post-randomization
measure: Depression severity as measured by BDI2 and K6
timeFrame: 15 months post-randomization
measure: Work performance as measured by HPQ and by job retention
timeFrame: 15 months post-randomization
measure: Client satisfaction as measured by VAS
timeFrame: 15 months post-randomization
measure: Use of EAP services and other health services
timeFrame: 15 months post-randomization
measure: Suicidal attempt and/or hospitalization (physical or mental)
timeFrame: 15 months post-randomization
measure: Time to incident major or minor depressive episode
timeFrame: 15 months post-randomization
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University
state: Aichi
Study officials:
affiliation: Nagoya City University
name: Toshiaki Furukawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.