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

NCT00610259 | Completed Phase 2

• 2 other identifiers: NCUPsychiatry001HLSRG (Ministry of Health)
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder

Keywords

Depressive disorder; Sleep initiation and maintenance disorder; Behavior therapy

Outcome Measures

Primary Outcomes (1)

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

  at 8-week

Secondary Outcomes (9)

• "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

Study Arms (2)

1

EXPERIMENTAL

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

Behavioral: brief behavioral therapy for insomnia (bBT-I); Other: Treatment as usual (TAU)

2

ACTIVE COMPARATOR

Treatment as usual (TAU)

Other: Treatment as usual (TAU)

Interventions

brief behavioral therapy for insomnia (bBT-I) BEHAVIORAL

4 50-minute individual sessions every week for 4 weeks

1

Treatment as usual (TAU) OTHER

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

1; 2

Eligibility Criteria

• Age: 20 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Nagoya City University: lead
• Kochi University: collaborator

Study Sites (1)

Nagoya City University Graduate School of Medical Sciences

Nagoya, Aichi-ken, 467-8601, Japan

Location

Related Publications (2)

• 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.

  PMID: 24733990 DERIVED

• 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.

  PMID: 21457679 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Depressive Disorder

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Mood Disorders; Mental Disorders

Study Officials

• Toshiaki A Furukawa, MD, PhD

  Nagoya City University Graduate School of Medical Sciences

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: January 16, 2008
• First Posted: February 7, 2008
• Study Start: January 1, 2008
• Primary Completion: July 1, 2009
• Study Completion: August 1, 2009
• Last Updated: September 18, 2009

Record last verified: 2009-09

Locations

JP (1)