TRIAD - Treatment of Insomnia and Depression

Phase 2

Completed

• Conditions: Sleep Initiation and Maintenance Disorders; Depression
• Interventions: Drug: Antidepressant; Behavioral: Desensitization Therapy for Insomnia; Behavioral: Cognitive Behavioral Therapy for Insomnia

• Registration Number: NCT00767624
• Lead Sponsor: Stanford University

Brief Summary

The aim of the proposed three-site study is to increase the rate of full remission from major depressive disorder (MDD) at the end of 16 weeks of treatment for people who experience both major depressive disorder and insomnia.

Detailed Description

Participants with major depressive disorder and insomnia who meet all study criteria will receive state-of-the-art antidepressant medications and one of two insomnia therapies. The specific therapy for insomnia will be determined by chance (like a flip of a coin), with an equal chance to receive either cognitive-behavioral therapy for insomnia or desensitization psychotherapy for insomnia. The study physician will select an initial antidepressant medication from a list of three possible medications . If that medication is not helpful, another medication may be tried after 8 weeks or in the event of severe side effects.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2008-10-03
• Study First Submitted QC: 2008-10-06
• Study First Posted: 2008-10-07
• Study Start: 2008-12
• Primary Completion: 2015-06
• Study Completion: 2015-06
• Results First Submitted: 2016-08-05
• Status Verified: 2016-10
• Results First Submitted QC: 2016-10-10
• Last Update Submitted: 2016-10-10
• Results First Posted: 2016-12-05
• Last Update Posted: 2016-12-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 150

Inclusion Criteria

1. Meets criteria for Major Depressive Disorder
2. Between 18 and 75 years of age and adequately fluent in English
3. Meets criteria for an insomnia disorder

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Exclusion Criteria

1. Women who are currently pregnant, breast-feeding, or not using a reliable birth control method.
2. People for whom the antidepressant medication(s) provided in the study is not indicated
3. People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications.
4. People with uncontrolled medical conditions.
5. People with moderate or severe sleep disorders other than insomnia
6. Individuals on a fixed night shift or rotating work schedule that requires a night shift.
7. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
antidepressant + desensitization	Antidepressant	Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
antidepressant + desensitization	Desensitization Therapy for Insomnia	Combined antidepressant medication (determined by an algorithm) plus desensitization therapy
antidepressant + cognitive behavioral	Antidepressant	Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy
antidepressant + cognitive behavioral	Cognitive Behavioral Therapy for Insomnia	Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy

Primary Outcome Measures

Name	Time	Method
Percent of Participants With Depression Remission	16 weeks	Depression remission was defined if both a and b below are satisfied; 1. absence of both depressed mood and anhedonia for at least three consecutive weeks; 2. no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks

Secondary Outcome Measures

Name	Time	Method
Percentage of Participants in Insomnia Remission	16 weeks	Remission was defined as endpoint ISI\<8. The ISI scale score ranges from 0 to 28 with lower scores representing less severe insomnia. A score of 0-7 is interpreted as absence of insomnia.

Trial Locations

Locations (3)

Duke University; 🇺🇸 Durham, North Carolina, United States

University of Pittsburgh; 🇺🇸 Pittsburgh, Pennsylvania, United States

Stanford University School of Medicine; 🇺🇸 Stanford, California, United States