Effects of Insomnia Treatment on Metabolism in Patients With Depression

NCT ID: NCT04719143

Last Updated: 2023-01-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

10 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-12-20

Study Completion Date

2022-12-20

Brief Summary

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

Detailed Description

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Conditions

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Insomnia Chronic Insomnia Insomnia, Primary Depression Depressive Symptoms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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CBT-I

Group Type ACTIVE_COMPARATOR

Cognitive Behavioral Therapy for Insomnia (CBT-I)

Intervention Type BEHAVIORAL

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

Waitlist Control

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Cognitive Behavioral Therapy for Insomnia (CBT-I)

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

Intervention Type BEHAVIORAL

Eligibility Criteria

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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)
Minimum Eligible Age

21 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Doris Duke Charitable Foundation

OTHER

Sponsor Role collaborator

University of Pennsylvania

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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The University of Pennsylvania

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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831841

Identifier Type: -

Identifier Source: org_study_id

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