TRIAD - Treatment of Insomnia and Depression

Study Overview
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Brief Summary
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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
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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.

Official Title
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Improving Depression Outcome by Adding Insomnia Therapy to Antidepressants

Conditions
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Sleep Initiation and Maintenance Disorders, Depression

Intervention / Treatment
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* Drug: Antidepressant
* Behavioral: Desensitization Therapy for Insomnia
* Behavioral: Cognitive Behavioral Therapy for Insomnia


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Meets criteria for Major Depressive Disorder Between 18 and 75 years of age and adequately fluent in English Meets criteria for an insomnia disorder Exclusion Criteria: Women who are currently pregnant, breast-feeding, or not using a reliable birth control method. People for whom the antidepressant medication(s) provided in the study is not indicated People who have had minimum adequate trials of (or have not been able to tolerate) all three study medications. People with uncontrolled medical conditions. People with moderate or severe sleep disorders other than insomnia Individuals on a fixed night shift or rotating work schedule that requires a night shift. Patients with a current principal diagnosis of a psychiatric disorder that necessitates treatment that is not offered in the study.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: antidepressant + desensitization<br>Combined antidepressant medication (determined by an algorithm) plus desensitization therapy | Drug: Antidepressant<br>* Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance<br>Behavioral: Desensitization Therapy for Insomnia<br> <br> |
| Other: antidepressant + cognitive behavioral<br>Combined antidepressant medication (determined by algorithm) plus cognitive behavioral therapy | Drug: Antidepressant<br>* Possible antidepressants are sertraline, escitalopram, desvenlafaxine, based on past history, response and tolerance<br>Behavioral: Cognitive Behavioral Therapy for Insomnia<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percent of Participants With Depression Remission | Depression remission was defined if both a and b below are satisfied absence of both depressed mood and anhedonia for at least three consecutive weeks no more than two other diagnostic criterion symptoms of depression met for at least three consecutive weeks | 16 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants in Insomnia Remission | 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. | 16 weeks |