Effects of Insomnia Treatment on Metabolism in Patients With Depression

Study Overview
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Brief Summary
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This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.

Official Title
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Effects of Insomnia Treatment on Metabolism in Patients With Depression

Conditions
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Insomnia Chronic, Insomnia, Insomnia, Primary, Depression, Depressive Symptoms

Intervention / Treatment
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* Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Insomnia Severity Index > 14 Meet diagnostic criteria for Insomnia Meet diagnostic criteria for Major Depressive Disorder Either currently taking an SSRI/SNRI or no antidepressant Exclusion Criteria: BMI > 30 Those with unstable medical conditions defined by change in diagnosis or medication in past 2 months Those with clinically significant comorbid psychiatric conditions (e.g., Bipolar disorder) Those with known untreated sleep apnea or other clinically significant sleep disorder other than insomnia Those currently taking medications that affect sleep or metabolism (e.g., stimulants, thyroid meds)

Ages Eligible for Study
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Minimum Age: 21 Years
Maximum Age: 60 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: Other
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: CBT-I<br> | Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)<br>* Subjects receive 6-8 CBT-I sessions in an individual format.<br>|
| No Intervention: Waitlist Control<br> | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Metabolomic Assays | Blood samples will be collected at enrollment . We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control. | Baseline (week 0) | 
| Metabolomic Assays | Blood samples will be collected 2 weeks following the completion of CBT-I to examine metabolic markers of response to CBT-I. We will use NMR Spectroscopy to examine serum metabolite changes in patients with insomnia before and after CBT-I, in comparison with therapy control. | 2 weeks post-treatment (week 10 on average) | 
| Insomnia Severity Index | A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs. | Baseline (week 0) | 
| Insomnia Severity Index | A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs. | 2 weeks post-treatment (week 10 on average) | 
| Insomnia Severity Index | A 7-item (0-4 Likert scale) measure with a total score of 28. The norms for the scale are: 0-7 represents no clinically significant insomnia; 8-14 represents sub-threshold insomnia; 15-21 represents clinical insomnia (moderate severity); 21-28 represents clinical insomnia (severe). The Insomnia Severity Index, the primary outcome of Aim 1, demonstrates good internal consistency (alpha=.74) and is routinely used as the primary outcome measure in insomnia RCTs. | 3 months post-treatment (week 20 on average) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Metabolism, Metabolomics