NCT04719143

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2018

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 20, 2018

Completed
2 years until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 22, 2021

Completed
1.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 20, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 20, 2022

Completed
Last Updated

January 17, 2023

Status Verified

January 1, 2023

Enrollment Period

4 years

First QC Date

December 9, 2020

Last Update Submit

January 13, 2023

Conditions

Insomnia ChronicInsomniaInsomnia, PrimaryDepressionDepressive Symptoms

Keywords

MetabolismMetabolomics

Outcome Measures

Primary Outcomes (5)

  • 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.

    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.

    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.

    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.

    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.

    3 months post-treatment (week 20 on average)

Study Arms (2)

CBT-I

ACTIVE COMPARATOR
Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Waitlist Control

NO INTERVENTION

Interventions

Cognitive Behavioral Therapy for Insomnia (CBT-I)BEHAVIORAL

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

CBT-I

Eligibility Criteria

Age21 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

The University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance DisordersDepression

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, IntrinsicDyssomniasSleep Wake DisordersNervous System DiseasesMental DisordersBehavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and Activities

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 9, 2020

First Posted

January 22, 2021

Study Start

December 20, 2018

Primary Completion

December 20, 2022

Study Completion

December 20, 2022

Last Updated

January 17, 2023

Record last verified: 2023-01

Data Sharing

IPD Sharing
Will not share

Locations

US(1)