Effects of Insomnia Treatment on Metabolism in Patients With Depression

University of Pennsylvania

Status: Completed

Conditions: Depressive Symptoms; Insomnia; Depression; Insomnia, Primary; Insomnia Chronic

Treatments: Behavioral: Cognitive Behavioral Therapy for Insomnia (CBT-I)

Study type: Interventional

Funder types: Other

Identifiers

NCT04719143

831841

Details and patient eligibility

About

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

Enrollment: 10 patients

Sex: All

Ages: 21 to 60 years old

Volunteers: No 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)

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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10 participants in 2 patient groups

CBT-I

Active Comparator group

Treatment:

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

Waitlist Control

No Intervention group