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

Major Depressive Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00610259
• Other study ID #: NCUPsychiatry001
• Secondary ID: HLSRG (Ministry
• Status: Completed
• Phase: Phase 2/Phase 3
• First received: January 16, 2008
• Last updated: September 17, 2009
• Start date: January 2008
• Est. completion date: August 2009

Study information

• Verified date: September 2009
• Source: Nagoya City University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Japan: Ministry of Health, Labor and Welfare
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 2009
• Est. primary completion date: July 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Depression
• Depressive Disorder
• Depressive Disorder, Major
• Major Depressive Disorder

Intervention

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.

Locations

Country	Name	City	State
Japan	Nagoya City University Graduate School of Medical Sciences	Nagoya	Aichi

Sponsors (2)

Lead Sponsor	Collaborator
Nagoya City University	Kochi University

Country where clinical trial is conducted

Japan, 

Outcome

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