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

This study has been completed.
Sponsor:
Collaborator:
Kochi University
Information provided by:
Nagoya City University
ClinicalTrials.gov Identifier:
NCT00610259
First received: January 16, 2008
Last updated: September 17, 2009
Last verified: September 2009
  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
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (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

Resource links provided by NLM:


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 ] [ Designated as safety issue: No ]

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 ] [ Designated as safety issue: No ]
  • "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 ] [ Designated as safety issue: No ]
  • Changes in the total ISI score between the baseline and the 4-week assessment [ Time Frame: at 4-week ] [ Designated as safety issue: No ]
  • 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 ] [ Designated as safety issue: No ]
  • Changes in the total score of the modified PSQI between the baseline and the 4-week assessment [ Time Frame: at 4-week ] [ Designated as safety issue: No ]
  • Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment [ Time Frame: at 8-week ] [ Designated as safety issue: No ]
  • Changes in the 17- HAMD between the baseline and the 4-week assessment [ Time Frame: at 4-week ] [ Designated as safety issue: No ]
  • Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment [ Time Frame: at 8-week ] [ Designated as safety issue: No ]
  • Changes in the SF-36 scores between the baseline and the 4-week assessment [ Time Frame: at 4-week ] [ Designated as safety issue: No ]

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

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided by Nagoya City University

Additional 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)
Study First Received: January 16, 2008
Last Updated: September 17, 2009
Health Authority: Japan: Ministry of Health, Labor and Welfare

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
Mood Disorders
Mental Disorders
Behavioral Symptoms

ClinicalTrials.gov processed this record on July 24, 2014