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Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00610259
First Posted: February 7, 2008
Last Update Posted: September 18, 2009
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
Kochi University
Information provided by:
Nagoya City University
  Purpose
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.

Condition Intervention Phase
Major Depressive Disorder Behavioral: brief behavioral therapy for insomnia (bBT-I) Other: Treatment as usual (TAU) Phase 2 Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia - An Assessors-blinded, Randomized Controlled Effectiveness Trial

Further study details as provided by Nagoya City University:

Primary Outcome Measures:
  • Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment [ Time Frame: at 8-week ]

Secondary Outcome Measures:
  • "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 ]

Estimated Enrollment: 40
Study Start Date: January 2008
Study Completion Date: August 2009
Primary Completion Date: July 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU)
Behavioral: brief behavioral therapy for insomnia (bBT-I)
4 50-minute individual sessions every week for 4 weeks
Other: Treatment as usual (TAU)
The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.
Active Comparator: 2
Treatment as usual (TAU)
Other: Treatment as usual (TAU)
The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. DSM-IV major depressive disorder, as ascertained by the Structured Clinical Interview for DSM-IV Axis I disorders (SCID)
  2. Either sex, between 20 and 70 years of age at the time of entry into the trial
  3. Outpatient at the time of entry into the trial
  4. 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.
  5. 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.
  6. A score between 8 and 23 on the 17-GRID-HAMD.
  7. 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

Exclusion Criteria:

  1. Their mental or physical status at the time of entry into the trial is regarded as so critical as to need immediate hospitalisation
  2. A serious suicidal risk, defined as a score of 3 or more on item 3 (suicidal ideation) of the 17-GRID-HAMD
  3. Patients who have had or are having any structured psychotherapy (e.g. cognitive therapy, or family therapy) at the time of entry
  4. 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
  5. Patients with duration of depression shorter than 2 months
  6. Their insomnia is considered to derive from sleep apnoea or periodic limb movements during sleep, judged by their clinicians.
  7. Patients who engage in work involving night-shift, which might influence sleep status
  8. Patients currently taking methylphenidate or modafinil.
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00610259


Locations
Japan
Nagoya City University Graduate School of Medical Sciences
Nagoya, Aichi, Japan, 467-8601
Sponsors and Collaborators
Nagoya City University
Kochi University
Investigators
Principal Investigator: Toshiaki A Furukawa, MD, PhD Nagoya City University Graduate School of Medical Sciences
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Toshiaki Furukawa, Nagoya City University
ClinicalTrials.gov Identifier: NCT00610259     History of Changes
Other Study ID Numbers: NCUPsychiatry001
HLSRG (Ministry of Health)
First Submitted: January 16, 2008
First Posted: February 7, 2008
Last Update Posted: September 18, 2009
Last Verified: September 2009

Keywords provided by Nagoya City University:
Depressive disorder
Sleep initiation and maintenance disorder
Behavior therapy

Additional relevant MeSH terms:
Depressive Disorder
Depression
Depressive Disorder, Major
Sleep Initiation and Maintenance Disorders
Mood Disorders
Mental Disorders
Behavioral Symptoms
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Wake Disorders
Nervous System Diseases