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

Study Overview
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Brief Summary
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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.

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

Conditions
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Major Depressive Disorder

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


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 70 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>brief behavioral therapy for insomnia (bBT-I) in addition to treatment as usual (TAU) | Behavioral: brief behavioral therapy for insomnia (bBT-I)<br>* 4 50-minute individual sessions every week for 4 weeks<br>Other: Treatment as usual (TAU)<br>* The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.<br>|
| Active Comparator: 2<br>Treatment as usual (TAU) | Other: Treatment as usual (TAU)<br>* The psychiatrist-in-charge sees the patient once every 2 weeks for approximately 10 minutes each to monitor pharmacotherapy.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | 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 | Measure Description | 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Depressive disorder, Sleep initiation and maintenance disorder, Behavior therapy