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

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.

Study Overview

• Status: Completed
• Conditions: Major Depressive Disorder
• Intervention / Treatment: Behavioral: brief behavioral therapy for insomnia (bBT-I); Other: Treatment as usual (TAU)

• Study Type: Interventional
• Enrollment (Anticipated): 40
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Japan
  • Aichi
    • Nagoya, Aichi, Japan, 467-8601
      • Nagoya City University Graduate School of Medical Sciences

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Changes in the total Insomnia Severity Index (ISI) score between the baseline and the 8-week assessment	at 8-week

Secondary Outcome Measures

Outcome Measure	Time Frame
"No clinically significant insomnia" at the 8-week assessment, which is defined as 7 or less on the total ISI score	at 8-week
"No clinically significant insomnia" at the 4-week assessment, which is defined as 7 or less on the total ISI score	at 4-week
Changes in the total ISI score between the baseline and the 4-week assessment	at 4-week
Changes in the total score of the modified Pittsburgh Sleep Quality Index (PSQI) between the baseline and the 8-week assessment	at 8-week
Changes in the total score of the modified PSQI between the baseline and the 4-week assessment	at 4-week
Changes in the 17-item Hamilton Rating Scale for Depression (HAMD) between the baseline and the 8-week assessment	at 8-week
Changes in the 17- HAMD between the baseline and the 4-week assessment	at 4-week
Changes in the Short Form 36 (SF-36) scores between the baseline and the 8-week assessment	at 8-week
Changes in the SF-36 scores between the baseline and the 4-week assessment	at 4-week

Collaborators and Investigators

• Sponsor: Nagoya City University
• Collaborators: Kochi University
• Investigators: Principal Investigator: Toshiaki A Furukawa, MD, PhD, Nagoya City University Graduate School of Medical Sciences

Publications and helpful links

General 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.
• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2008
• Primary Completion (Actual): July 1, 2009
• Study Completion (Actual): August 1, 2009

Study Registration Dates

• First Submitted: January 16, 2008
• First Submitted That Met QC Criteria: January 24, 2008
• First Posted (Estimate): February 7, 2008

Study Record Updates

• Last Update Posted (Estimate): September 18, 2009
• Last Update Submitted That Met QC Criteria: September 17, 2009
• Last Verified: September 1, 2009

More Information

Terms related to this study

• Keywords: Depressive disorder; Behavior therapy; Sleep initiation and maintenance disorder
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Nervous System Diseases; Mood Disorders; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Depression; Depressive Disorder; Sleep Initiation and Maintenance Disorders; Depressive Disorder, Major
• Other Study ID Numbers: NCUPsychiatry001; HLSRG (Ministry of Health)