DepressionPhase 2/3NCT00885014
Telephone Cognitive-Behavioral Therapy (CBT) for Subthreshold Depression and Presenteeism in Workplace
A Phase 2/3 study testing CBT and EAP in people with Depression, run by Kyoto University at 1 site in Japan.
Trial 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)). Read more about this study
- Who is it for?
- Ages 20 to 57 years
- Conditions the study is for
- Depression
- What is being tested?
- CBT and EAP
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 118 participants
- Where
- 1 siteJapan
- Study dates
- Apr 2009to Sep 2011
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 57 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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)
Who cannot join
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
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)).
- Conditions
- Depression
- Being tested
- CBT, EAP
- Keywords
- Depressive disorder, Behavior therapy, Workplace, Subthreshold depression
- Medical subject headings
- Depression, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Telephone cognitive-behavioral therapy
EAPBehavioural
Employees Assistance Program
| Study group | Role | What they receive |
|---|---|---|
| CBT | Experimental | Telephone cognitive-behavioral therapy Receives: Behavioral: CBT; Behavioral: EAP |
| TAU | Active comparator | Treatment as usual through the Employees Assistance Program Receives: Behavioral: EAP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Depression severity as measured by Beck Depression Inventory-II (BDI2)
Measured: 4 months post-randomization
Work performance as measured by the Health and Work Performance Questionnaire (HPQ) "effective hours worked" for the past month
Measured: 4 months post-randomization
Secondary outcomes (8)
Depression severity as measured by Kessler Scale (K6)
Measured: 4 months post-randomization
Client satisfaction as measured by Visual Analogue Scale (VAS)
Measured: 4 months post-randomization
Depression severity as measured by BDI2 and K6
Measured: 15 months post-randomization
Work performance as measured by HPQ and by job retention
Measured: 15 months post-randomization
Client satisfaction as measured by VAS
Measured: 15 months post-randomization
Use of EAP services and other health services
Measured: 15 months post-randomization
Suicidal attempt and/or hospitalization (physical or mental)
Measured: 15 months post-randomization
Time to incident major or minor depressive episode
Measured: 15 months post-randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 118 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kyoto University
- Sponsor type
- University, hospital or other
- Collaborators
- Nagoya City University
- Responsible party
- Principal investigator, Toshiaki A. Furukawa, Kyoto University
- Investigators
- Toshiaki Furukawa, MD, PhD, Principal investigator, Nagoya City University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885014
- Sponsor's protocol ID
- NCUPsychiatry002
- Status last verified
- Mar 2012
- First submitted
- 20 Apr 2009
- Last updated
- 19 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 26602093Furukawa 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.
PubMed 22532849
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Telephone Cognitive-behavioral Therapy for Subthreshold Depression and Presenteeism in Workplace: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00885014
- Acronym / sponsor ID
- NCUPsychiatry002
- Conditions
- Depression
- Keywords
- Depressive disorder, Behavior therapy, Workplace, Subthreshold depression
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 118 participants (actual)
- Lead sponsor
- Kyoto UniversityUniversity, hospital or other
- Collaborators
- Nagoya City University
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 21 Apr 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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)).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT | Experimental | Behavioral: CBT, Behavioral: EAPTelephone cognitive-behavioral therapy |
| TAU | Active comparator | Behavioral: EAPTreatment as usual through the Employees Assistance Program |
Who may qualify
- Ages
- 20 to 57 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (9 listed)
- 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]
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CBTTelephone cognitive-behavioral therapy | Behavioural | CBT |
| EAPEmployees Assistance Program | Behavioural | CBT, TAU |
Primary outcome
Depression severity as measured by Beck Depression Inventory-II (BDI2)
Time frame: 4 months post-randomization
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
8 secondary outcomes
Depression severity as measured by Kessler Scale (K6)
Time frame: 4 months post-randomization
Client satisfaction as measured by Visual Analogue Scale (VAS)
Time frame: 4 months post-randomization
Depression severity as measured by BDI2 and K6
Time frame: 15 months post-randomization
Work performance as measured by HPQ and by job retention
Time frame: 15 months post-randomization
Client satisfaction as measured by VAS
Time frame: 15 months post-randomization
Use of EAP services and other health services
Time frame: 15 months post-randomization
Suicidal attempt and/or hospitalization (physical or mental)
Time frame: 15 months post-randomization
Time to incident major or minor depressive episode
Time frame: 15 months post-randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2012.
- Derived from this study: PubMed 26602093Hayasaka 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.
- Derived from this study: PubMed 22532849Furukawa 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Toshiaki Furukawa, MD, PhD principal investigator
Nagoya City University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing CBT and EAP in people with Depression, run by Kyoto University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 19 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Depression severity as measured by Beck Depression Inventory-II (BDI2) (time frame: 4 months post-randomization). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00885014, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Mar 2012.