Behavioral Insomnia Therapy For Those With Insomnia and Depression
NCT00620789 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 477
Last updated 2013-05-31
Summary
This study is a randomized clinical trial to test the efficacy of Cognitive-Behavioral Insomnia Therapy when used in isolation or in combination with antidepressant medication (escitalopram) among patients with Major depressive disorder and insomnia.
Conditions
Interventions
- DRUG
-
Escitalopram + CBT-I
* Escitalopram, 10 mg daily for the duration of the study (6 months) * CBT-I, four biweekly sessions during eight week Treatment phase.
- BEHAVIORAL
-
CBT-I plus placebo antidepressant medication
* CBT-I, 4 biweekly sessions, eight week Treatment phase. * Placebo,daily for duration of study(6 months).
- DRUG
-
Escitalopram
* Escitalopram, 10 mg daily for the duration of the study (6 months) * SH, four biweekly sessions during eight week Treatment phase
Sponsors & Collaborators
-
Toronto Metropolitan University
lead OTHER
Principal Investigators
-
Colleen Carney, PhD · Licensed, North Carolina Psychology Board, Ontario Psychological Association, Association for Behavioral and Cognative Therapies, ABCT Insomnia and other Sleep Disorders Special Interest Group, Sleep Research Society, American Academy of Sleep Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- TRIPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 64 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2008-03-31
- Primary Completion
- 2014-01-31
- Completion
- 2014-01-31
Countries
- Canada
Study Locations
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