Effects of Insomnia Treatment on Metabolism in Patients With Depression
Study Details
Study Description
Brief Summary
This project will examine changes in metabolism and depressive symptoms after receiving CBT-I in 30 subjects with insomnia disorder and MDD.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
N/A |
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Active Comparator: CBT-I
|
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)
Subjects receive 6-8 CBT-I sessions in an individual format.
|
| No Intervention: Waitlist Control
|
Outcome Measures
Primary Outcome Measures
- Metabolomic Assays [Baseline (week 0)]
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.
- Metabolomic Assays [2 weeks post-treatment (week 10 on average)]
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.
- Insomnia Severity Index [Baseline (week 0)]
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.
- Insomnia Severity Index [2 weeks post-treatment (week 10 on average)]
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.
- Insomnia Severity Index [3 months post-treatment (week 20 on average)]
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.
Eligibility Criteria
Criteria
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)
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | The University of Pennsylvania | Philadelphia | Pennsylvania | United States | 19104 |
Sponsors and Collaborators
- University of Pennsylvania
- Doris Duke Charitable Foundation
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- 831841