Effects of Insomnia Treatment on Metabolism in Patients With Depression

Not Applicable

Completed

• Conditions: Depression; Insomnia; Insomnia Chronic; Insomnia, Primary; Depressive Symptoms

• Registration Number: NCT04719143
• Lead Sponsor: University of Pennsylvania

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study Start: 2018-12-20
• Study First Submitted: 2020-12-09
• Study First Submitted QC: 2021-01-20
• Study First Posted: 2021-01-22
• Primary Completion: 2022-12-20
• Study Completion: 2022-12-20
• Status Verified: 2023-01
• Last Update Submitted: 2023-01-13
• Last Update Posted: 2023-01-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

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)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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	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.

Trial Locations

Locations (1)

The University of Pennsylvania; 🇺🇸 Philadelphia, Pennsylvania, United States