Major Depressive DisorderPhase 2/3NCT00610259
Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia
A Phase 2/3 study testing brief behavioral therapy for insomnia (bBT-I) and Treatment as usual (TAU) in people with Major Depressive Disorder, run by Nagoya City University at 1 site in Japan.
Trial summary
The purpose of this study is to examine the effectiveness of brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for refractory insomnia among patients with major depression in partial remission. Read more about this study
- Who is it for?
- Ages 20 to 70 years
- Conditions the study is for
- Major Depressive Disorder
- What is being tested?
- brief behavioral therapy for insomnia (bBT-I) and Treatment as usual (TAU)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteJapan
- Study dates
- Jan 2008to Aug 2009
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV major depressive disorder, as ascertained by the Structured Clinical Interview for DSM-IV Axis I disorders (SCID)
- Either sex, between 20 and 70 years of age at the time of entry into the trial
- Outpatient at the time of entry into the trial
- For the index episode, patients have to have already been on two types of adequate doses of antidepressants for no shorter than 4 weeks for each medication or already on two types of antidepressants for 8 weeks in total even if the doses of the drugs have not been adequate due to side effects. The medication has not been changed for at least 4 weeks prior to the study entry.
- A score of 2 on at least one of the three sleep items of the 17-GRID-HAMD and a score of 8 or more on the ISI.
- A score between 8 and 23 on the 17-GRID-HAMD.
- Agreement to the requirements that i) no change of medication will be allowed during the first 4 weeks of their study period, and ii) all the treatment sessions both of bBT-I and of TAU will be audiotaped for the purpose of checking their adherence to the protocol
Who cannot join
- Their mental or physical status at the time of entry into the trial is regarded as so critical as to need immediate hospitalisation
- A serious suicidal risk, defined as a score of 3 or more on item 3 (suicidal ideation) of the 17-GRID-HAMD
- Patients who have had or are having any structured psychotherapy (e.g. cognitive therapy, or family therapy) at the time of entry
- Patients with current diagnosis of primary anxiety or personality disorder, insomnia associated with another sleep disorder, significant medical problems, current drug or alcohol substance abuse or dependence, or psychosis, or with a history of schizophrenia or bipolar disorder
- Patients with duration of depression shorter than 2 months
- Their insomnia is considered to derive from sleep apnoea or periodic limb movements during sleep, judged by their clinicians.
- Patients who engage in work involving night-shift, which might influence sleep status
- Patients currently taking methylphenidate or modafinil.
Trial locations and contacts
1 site in 1 country.
Japan1 site
Nagoya City University Graduate School of Medical Sciences
Nagoya, Aichi-ken, 467-8601
About this study
Official title: Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia - An Assessors-blinded, Randomized Controlled Effectiveness Trial
The purpose of this study is to examine the effectiveness of brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for refractory insomnia among patients with major depression in partial remission.
- Conditions
- Major Depressive Disorder
- Being tested
- brief behavioral therapy for insomnia (bBT-I), Treatment as usual (TAU)
- Keywords
- Depressive disorder, Sleep initiation and maintenance disorder, Behavior therapy
- Medical subject headings
- Depressive Disorder, Major, Depressive Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brief behavioral therapy for insomnia (bBT-I)Behavioural
4 50-minute individual sessions every week for 4 weeks
The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) Receives: Behavioral: brief behavioral therapy for insomnia (bBT-I); Other: Treatment as usual (TAU) |
| 2 | Active comparator | Treatment as usual (TAU) Receives: Other: Treatment as usual (TAU) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment
Measured: at 8-week
Secondary outcomes (9)
"No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score
Measured: at 8-week
"No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score
Measured: at 4-week
Changes in the total ISI score between the baseline and the 4-week assessment
Measured: at 4-week
Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment
Measured: at 8-week
Changes in the total score of the modified PSQI between the baseline and the 4-week assessment
Measured: at 4-week
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment
Measured: at 8-week
Changes in the 17- HAMD between the baseline and the 4-week assessment
Measured: at 4-week
Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment
Measured: at 8-week
Changes in the SF-36 scores between the baseline and the 4-week assessment
Measured: at 4-week
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2008 (estimated)
- Study startJan 2008
- Primary completionJul 2009
- Study completionAug 2009
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 Major Depressive DisorderStudies 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nagoya City University
- Sponsor type
- University, hospital or other
- Collaborators
- Kochi University
- Investigators
- Toshiaki A Furukawa, MD, PhD, Principal investigator, Nagoya City University Graduate School of Medical Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00610259
- Sponsor's protocol ID
- NCUPsychiatry001
- Other IDs
- HLSRG (Ministry of Health)
- Status last verified
- Sep 2009
- First submitted
- 16 Jan 2008
- Last updated
- 18 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Shimodera S, Watanabe N, Furukawa TA, Katsuki F, Fujita H, Sasaki M, Perlis ML. Change in quality of life after brief behavioral therapy for insomnia in concurrent depression: analysis of the effects of a randomized controlled trial. J Clin Sleep Med. 2014 Apr 15;10(4):433-9. doi: 10.5664/jcsm.3624.
PubMed 24733990Watanabe N, Furukawa TA, Shimodera S, Morokuma I, Katsuki F, Fujita H, Sasaki M, Kawamura C, Perlis ML. Brief behavioral therapy for refractory insomnia in residual depression: an assessor-blind, randomized controlled trial. J Clin Psychiatry. 2011 Dec;72(12):1651-8. doi: 10.4088/JCP.10m06130gry. Epub 2011 Mar 8.
PubMed 21457679
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia - An Assessors-blinded, Randomized Controlled Effectiveness Trial
- ClinicalTrials.gov ID
- NCT00610259
- Acronym / sponsor ID
- NCUPsychiatry001
- Conditions
- Major Depressive Disorder
- Keywords
- Depressive disorder, Sleep initiation and maintenance disorder, Behavior therapy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Nagoya City UniversityUniversity, hospital or other
- Collaborators
- Kochi University
- Study start
- Jan 2008
- Primary completion
- Jul 2009 (actual)
- Study completion
- Aug 2009 (actual)
- First posted
- 7 Feb 2008 (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 this study is to examine the effectiveness of brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) in comparison with TAU alone for refractory insomnia among patients with major depression in partial remission.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: brief behavioral therapy for insomnia (bBT-I), Other: Treatment as usual (TAU)brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) |
| 2 | Active comparator | Other: Treatment as usual (TAU)Treatment as usual (TAU) |
Who may qualify
- Ages
- 20 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- DSM-IV major depressive disorder, as ascertained by the Structured Clinical Interview for DSM-IV Axis I disorders (SCID)
- Either sex, between 20 and 70 years of age at the time of entry into the trial
- Outpatient at the time of entry into the trial
- For the index episode, patients have to have already been on two types of adequate doses of antidepressants for no shorter than 4 weeks for each medication or already on two types of antidepressants for 8 weeks in total even if the doses of the drugs have not been adequate due to side effects. The medication has not been changed for at least 4 weeks prior to the study entry.
- A score of 2 on at least one of the three sleep items of the 17-GRID-HAMD and a score of 8 or more on the ISI.
Key exclusion criteria (8 listed)
- Their mental or physical status at the time of entry into the trial is regarded as so critical as to need immediate hospitalisation
- A serious suicidal risk, defined as a score of 3 or more on item 3 (suicidal ideation) of the 17-GRID-HAMD
- Patients who have had or are having any structured psychotherapy (e.g. cognitive therapy, or family therapy) at the time of entry
- Patients with current diagnosis of primary anxiety or personality disorder, insomnia associated with another sleep disorder, significant medical problems, current drug or alcohol substance abuse or dependence, or psychosis, or with a history of schizophrenia or bipolar disorder
- Patients with duration of depression shorter than 2 months
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 |
|---|---|---|
| brief behavioral therapy for insomnia (bBT-I)4 50-minute individual sessions every week for 4 weeks | Behavioural | 1 |
| Treatment as usual (TAU)The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy. | Other | 1, 2 |
Primary outcome
Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment
Time frame: at 8-week
9 secondary outcomes
"No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score
Time frame: at 8-week
"No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score
Time frame: at 4-week
Changes in the total ISI score between the baseline and the 4-week assessment
Time frame: at 4-week
Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment
Time frame: at 8-week
Changes in the total score of the modified PSQI between the baseline and the 4-week assessment
Time frame: at 4-week
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment
Time frame: at 8-week
Changes in the 17- HAMD between the baseline and the 4-week assessment
Time frame: at 4-week
Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment
Time frame: at 8-week
Changes in the SF-36 scores between the baseline and the 4-week assessment
Time frame: at 4-week
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 18 Sep 2009.
- Derived from this study: PubMed 24733990Shimodera S, Watanabe N, Furukawa TA, Katsuki F, Fujita H, Sasaki M, Perlis ML. Change in quality of life after brief behavioral therapy for insomnia in concurrent depression: analysis of the effects of a randomized controlled trial. J Clin Sleep Med. 2014 Apr 15;10(4):433-9. doi: 10.5664/jcsm.3624.
- Derived from this study: PubMed 21457679Watanabe N, Furukawa TA, Shimodera S, Morokuma I, Katsuki F, Fujita H, Sasaki M, Kawamura C, Perlis ML. Brief behavioral therapy for refractory insomnia in residual depression: an assessor-blind, randomized controlled trial. J Clin Psychiatry. 2011 Dec;72(12):1651-8. doi: 10.4088/JCP.10m06130gry. Epub 2011 Mar 8.
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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 A Furukawa, MD, PhD principal investigator
Nagoya City University Graduate School of Medical Sciences
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 brief behavioral therapy for insomnia (bBT-I) and Treatment as usual (TAU) in people with Major Depressive Disorder, run by Nagoya City 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 7 inclusion and 8 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 18 Sep 2009. 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?
Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment (time frame: at 8-week). 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 NCT00610259, 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 18 Sep 2009.