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

Nagoya City University

Status and phase: Completed; Phase 3; Phase 2

Conditions: Major Depressive Disorder

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

Study type: Interventional

Funder types: Other

Identifiers

NCT00610259

NCUPsychiatry001

HLSRG (Ministry of Health)

Details and patient eligibility

About

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.

Enrollment: 40 estimated patients

Sex: All

Ages: 20 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups

1

Experimental group

Description:

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

Treatment:

Other: Treatment as usual (TAU)

Behavioral: brief behavioral therapy for insomnia (bBT-I)

2

Active Comparator group

Description:

Treatment as usual (TAU)

Treatment:

Other: Treatment as usual (TAU)