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

NCT ID: NCT00610259

Last Updated: 2009-09-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2/PHASE3
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-01-31
• Study Completion Date: 2009-08-31

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

1

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

Group Type: EXPERIMENTAL

brief behavioral therapy for insomnia (bBT-I)

Intervention Type: BEHAVIORAL

4 50-minute individual sessions every week for 4 weeks

Treatment as usual (TAU)

Intervention Type: OTHER

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

2

Treatment as usual (TAU)

Group Type: ACTIVE_COMPARATOR

Treatment as usual (TAU)

Intervention Type: OTHER

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

Interventions

brief behavioral therapy for insomnia (bBT-I)

4 50-minute individual sessions every week for 4 weeks

Intervention Type: BEHAVIORAL

Treatment as usual (TAU)

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

Intervention Type: OTHER

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kochi University

OTHER

Sponsor Role: collaborator

Nagoya City University

OTHER

Sponsor Role: lead

Responsible Party

Nagoya City University

Principal Investigators

Toshiaki A Furukawa, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Nagoya City University Graduate School of Medical Sciences

Locations

Nagoya City University Graduate School of Medical Sciences

Nagoya, Aichi-ken, Japan

Countries

Japan

References

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.

Reference Type: DERIVED

PMID: 24733990 (View on PubMed)

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.

Reference Type: DERIVED

PMID: 21457679 (View on PubMed)

Other Identifiers

HLSRG (Ministry of Health)

Identifier Type: -

Identifier Source: secondary_id

NCUPsychiatry001

Identifier Type: -

Identifier Source: org_study_id