Cognitive Behavioral Therapy and Trazodone Effects on Sleep and Blood Pressure in Insomnia

Penn State Health

Status and phase: Enrolling; Early Phase 1

Conditions: Blood Pressure, High; Insomnia; Blood Pressure; Insomnia, Primary; Insomnia Chronic

Treatments: Drug: Trazodone; Behavioral: Cognitive Behavioral Treatment for Insomnia (CBT-I); Other: Placebo

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT06281756

1UG3HL161342-01A1 (U.S. NIH Grant/Contract)

STUDY00022285

Details and patient eligibility

About

Individuals who have insomnia with short sleep duration (ISS) differ from individuals who have insomnia with normal sleep duration (INS) in terms of health risks (i.e., hypertension) and treatment response. This study will examine whether patients with ISS and INS demonstrate a differential response to two common insomnia treatments. One is behavioral, Cognitive Behavioral Therapy for Insomnia (CBT-I). The other is a widely prescribed, non-habit-forming medication, trazodone used at a low dose. The investigators' findings could lead to evidence-based treatment guidelines that help clinicians more effectively match treatments to insomnia patients and reduce associated health problems.

Enrollment: 600 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Age 18 or older
• Able to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
• Meets criteria for chronic insomnia
• Body Mass Index (BMI) 18.5 kg/m2 and higher

Exclusion criteria

• Age < 18
• Unable to read and effectively communicate in English at the United States sites or able to read and effectively communicate in English or French at the Canadian site.
• Unwilling to share email address/cell phone number to accept survey links.
• Life time diagnosis of psychotic or bipolar disorder
• Current use of supplemental oxygen for the treatment of sleep apnea
• History of severe apnea or an Apnea Hypopnea Index (AHI) ≥15 that is not currently treated with Positive Airway Pressure (PAP) therapy, an oral device or an implanted device, or was not treated with surgery or weight loss.
• Started new or changed treatment for sleep apnea in the past three months
• Does not meet criteria for chronic insomnia
• Meets criteria for narcolepsy or hypersomnia disorder
• Meets criteria for circadian rhythm disorder (including night shift work)
• Unstable medical conditions that would make participation unsafe or unfeasible
• Falls resulting in hospitalization, significant injury or fracture within past 12 months
• 2 hospitalizations or emergency room visits within past 12 months for chronic conditions
• Active chemotherapy or radiation therapy for cancer
• Lifetime diagnoses/treatment of chronic renal failure, hepatic insufficiency, chronic heart failure
• Does not agree to refrain from other treatments for insomnia beyond what is offered in this study
• BMI less than 18.5
• Substance abuse or dependence in the past 12 months
• Current use of prescription or over the counter medications taken for sleep greater than 2 times per week
• Current use of systemic corticosteroids or opiate medications
• Current pregnancy or breastfeeding; plans to get pregnant or unwillingness to use birth control for the length of the study
• Current use of medications contraindicated with trazodone
• Sleep apnea or periodic leg movement disorder as determined by sleep study
• Blood Pressure levels defined as seated SBP greater than 180 or DBP greater than 110 mmHg
• EKG corrected QT interval greater than or equal to 500 ms

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Triple Blind

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600 participants in 2 patient groups, including a placebo group

Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with placebo

Placebo Comparator group

Description:

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received placebo for 8 weeks.

Treatment:

Other: Placebo

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

Subjects treated with Cognitive Behavior Treatment for Insomnia (CBT-I) with Trazodone

Active Comparator group

Description:

Subjects with insomnia treated with Cognitive Behavior Treatment for Insomnia (CBT-I) for 8 weeks, then non-remitting subjects received trazodone for 8 weeks.

Treatment:

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

Drug: Trazodone