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

Primary Purpose

Major Depressive Disorder

Status

Completed

Phase

Phase 2

Locations

Japan

Study Type

Interventional

Intervention

brief behavioral therapy for insomnia (bBT-I)

Treatment as usual (TAU)

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Depressive disorder, Sleep initiation and maintenance disorder, Behavior therapy

Eligibility Criteria

20 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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.

Sites / Locations

Nagoya City University Graduate School of Medical Sciences

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU)

Treatment as usual (TAU)

Outcomes

Primary Outcome Measures

Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment

Secondary Outcome Measures

"No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score

"No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score

Changes in the total ISI score between the baseline and the 4-week assessment

Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment

Changes in the total score of the modified PSQI between the baseline and the 4-week assessment

Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment

Changes in the 17- HAMD between the baseline and the 4-week assessment

Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment

Changes in the SF-36 scores between the baseline and the 4-week assessment

Full Information

NCT ID

NCT00610259

First Posted

January 16, 2008

Last Updated

September 17, 2009

Sponsor

Nagoya City University

Collaborators

Kochi University

1. Study Identification

Unique Protocol Identification Number

NCT00610259

Brief Title

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

Official Title

Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia - An Assessors-blinded, Randomized Controlled Effectiveness Trial

Study Type

Interventional

2. Study Status

Record Verification Date

September 2009

Overall Recruitment Status

Completed

Study Start Date

January 2008 (undefined)

Primary Completion Date

July 2009 (Actual)

Study Completion Date

August 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Nagoya City University

Collaborators

Kochi University

4. Oversight

Data Monitoring Committee

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Major Depressive Disorder

Keywords

Depressive disorder, Sleep initiation and maintenance disorder, Behavior therapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU)

Arm Title

Arm Type

Active Comparator

Arm Description

Treatment as usual (TAU)

Intervention Type

Behavioral

Intervention Name(s)

brief behavioral therapy for insomnia (bBT-I)

Intervention Description

4 50-minute individual sessions every week for 4 weeks

Intervention Type

Other

Intervention Name(s)

Treatment as usual (TAU)

Intervention Description

The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.

Primary Outcome Measure Information:

Title

Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment

Time Frame

at 8-week

Secondary Outcome Measure Information:

Title

"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

Title

"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

Title

Changes in the total ISI score between the baseline and the 4-week assessment

Time Frame

at 4-week

Title

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

Title

Changes in the total score of the modified PSQI between the baseline and the 4-week assessment

Time Frame

at 4-week

Title

Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment

Time Frame

at 8-week

Title

Changes in the 17- HAMD between the baseline and the 4-week assessment

Time Frame

at 4-week

Title

Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment

Time Frame

at 8-week

Title

Changes in the SF-36 scores between the baseline and the 4-week assessment

Time Frame

at 4-week

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

70 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: 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 Exclusion Criteria: 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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Toshiaki A Furukawa, MD, PhD

Organizational Affiliation

Nagoya City University Graduate School of Medical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Nagoya City University Graduate School of Medical Sciences

City

Nagoya

State/Province

Aichi

ZIP/Postal Code

467-8601

Country

Japan

12. IPD Sharing Statement

Citations:

PubMed Identifier

24733990

Citation

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.

Results Reference

derived

PubMed Identifier

21457679

Citation

Watanabe 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.

Results Reference

derived

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

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