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Completed

NCT Number: NCT04719143

Effects of Insomnia Treatment on Metabolism in Patients With Depression

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

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Key information

Conditions

Insomnia Chronic Behavior Behavioral Symptoms Depression Depressive Symptoms Dyssomnias Insomnia Insomnia, Primary Mental Disorders Nervous System Diseases Sleep Disorders, Intrinsic Sleep Initiation and Maintenance Disorders Sleep Wake Disorders

Age range

21 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Behavioral

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

Primary outcomes

  1. Metabolomic Assays

    Time frame: 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.

  2. Metabolomic Assays

    Time frame: 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.

  3. Insomnia Severity Index

    Time frame: 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.

  4. Insomnia Severity Index

    Time frame: 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.

  5. Insomnia Severity Index

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Pennsylvania

Other

Collaborators

  • Doris Duke Charitable Foundation

Registry information

Important dates

Study start
2018
Primary completion
2022
Study completion
2022
First posted
Jan 22, 2021
Registry last updated
Jan 17, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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