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Effects of Insomnia Treatment on Metabolism in Patients With Depression

Primary Purpose

Insomnia Chronic, Insomnia, Insomnia, Primary

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Sponsored by
University of Pennsylvania
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Insomnia Chronic focused on measuring Metabolism, Metabolomics

Eligibility Criteria

21 Years - 60 Years (Adult)All SexesDoes not accept 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)

Sites / Locations

  • The University of Pennsylvania

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

CBT-I

Waitlist Control

Arm Description

Outcomes

Primary Outcome Measures

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.
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.
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.
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.
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.

Secondary Outcome Measures

Full Information

First Posted
December 9, 2020
Last Updated
January 13, 2023
Sponsor
University of Pennsylvania
Collaborators
Doris Duke Charitable Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT04719143
Brief Title
Effects of Insomnia Treatment on Metabolism in Patients With Depression
Official Title
Effects of Insomnia Treatment on Metabolism in Patients With Depression
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
December 20, 2018 (Actual)
Primary Completion Date
December 20, 2022 (Actual)
Study Completion Date
December 20, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Pennsylvania
Collaborators
Doris Duke Charitable Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia Chronic, Insomnia, Insomnia, Primary, Depression, Depressive Symptoms
Keywords
Metabolism, Metabolomics

7. Study Design

Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
10 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CBT-I
Arm Type
Active Comparator
Arm Title
Waitlist Control
Arm Type
No Intervention
Intervention Type
Behavioral
Intervention Name(s)
Cognitive Behavioral Therapy for Insomnia (CBT-I)
Intervention Description
Subjects receive 6-8 CBT-I sessions in an individual format.
Primary Outcome Measure Information:
Title
Metabolomic Assays
Description
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)
Title
Metabolomic Assays
Description
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)
Title
Insomnia Severity Index
Description
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)
Title
Insomnia Severity Index
Description
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)
Title
Insomnia Severity Index
Description
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
3 months post-treatment (week 20 on average)

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility 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)
Facility Information:
Facility Name
The University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Effects of Insomnia Treatment on Metabolism in Patients With Depression

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