NCT04719143 - Effects of Insomnia Treatment on Metabolism in Patients With Depression | Crick

Overview

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

NONE

Enrollment

10

Conditions

Insomnia Chronic Insomnia Insomnia, Primary Depression Depressive Symptoms

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)BEHAVIORAL

Subjects receive 6-8 CBT-I sessions in an individual format.

Eligibility

Sex: ALLMin age: 21 YearsMax age: 60 Years

Medical Language ↔ Plain English

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)

Locations (1)

The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: 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.

Time frame: 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.