Clinical trial NCT00610259: 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
Overall status: COMPLETED
Phase: PHASE2
PHASE3
Conditions: Major Depressive Disorder
Keywords: Depressive disorder
Sleep initiation and maintenance disorder
Behavior therapy
Lead sponsor: Nagoya City University
Sponsor class: OTHER
Collaborators: name: Kochi University
First posted: 2008-02-07
Enrollment: 40
Sex: ALL
Minimum age (years): 20
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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.

Primary outcomes:
measure: Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment
timeFrame: at 8-week
Secondary outcomes:
measure: "No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score
timeFrame: at 8-week
measure: "No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score
timeFrame: at 4-week
measure: Changes in the total ISI score between the baseline and the 4-week assessment
timeFrame: at 4-week
measure: Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment
timeFrame: at 8-week
measure: Changes in the total score of the modified PSQI between the baseline and the 4-week assessment
timeFrame: at 4-week
measure: Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment
timeFrame: at 8-week
measure: Changes in the 17- HAMD between the baseline and the 4-week assessment
timeFrame: at 4-week
measure: Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment
timeFrame: at 8-week
measure: Changes in the SF-36 scores between the baseline and the 4-week assessment
timeFrame: at 4-week
Other outcomes:
Locations:
city: Nagoya
country: Japan
facility: Nagoya City University Graduate School of Medical Sciences
state: Aichi
Study officials:
affiliation: Nagoya City University Graduate School of Medical Sciences
name: Toshiaki A Furukawa, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.