Effects of Insomnia Treatment on Metabolism in Patients With Depression

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04719143

Enrollment

Registered

2021-01-22

Start date

2018-12-20

Completion date

2022-12-20

Last updated

2023-01-17

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Metabolism, Metabolomics

Brief summary

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

Interventions

BEHAVIORALCognitive Behavioral Therapy for Insomnia (CBT-I)

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

OTHER

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

21 Years to 60 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame	Description
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.
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.

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026