Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Work… (NCT00885014) | Clinical Trial Compass
CompletedPhase 2/3
Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace
Japan118 participantsStarted 2009-04
Plain-language 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)).
Who can participate
Age range
20 Years – 57 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Depression severity as measured by Beck Depression Inventory-II (BDI2)
Timeframe: 4 months post-randomization
2
Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month