Status:
COMPLETED
Brief Behavioral Therapy for Insomnia (bBT-I) for Depressed Outpatients With Refractory Insomnia
Lead Sponsor:
Nagoya City University
Collaborating Sponsors:
Kochi University
Conditions:
Major Depressive Disorder
Eligibility:
All Genders
20-70 years
Phase:
PHASE2
PHASE3
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 ...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
January 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
August 1 2009
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT00610259
Start Date
January 1 2008
End Date
August 1 2009
Last Update
September 18 2009
Active Locations (1)
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1
Nagoya City University Graduate School of Medical Sciences
Nagoya, Aichi-ken, Japan, 467-8601