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

Study Overview
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Brief Summary
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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)).

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

Conditions
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Depression

Intervention / Treatment
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* Behavioral: CBT
* Behavioral: EAP


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 57 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CBT<br>Telephone cognitive-behavioral therapy | Behavioral: CBT<br>* Telephone cognitive-behavioral therapy<br>Behavioral: EAP<br>* Employees Assistance Program<br>|
| Active Comparator: TAU<br>Treatment as usual through the Employees Assistance Program | Behavioral: EAP<br>* Employees Assistance Program<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive disorder, Behavior therapy, Workplace, Subthreshold depression