An Evaluation of Insomnia Treatment to Reduce Cardiovascular Risk in Patients With Posttraumatic Stress Disorder

NCT04498754 | Completed

• 1 other identifier: PRO00100446
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Posttraumatic stress disorder (PTSD) is a chronic, debilitating psychiatric disorder that is associated with an increased risk of death due to cardiovascular disease (CVD). Most individuals with PTSD also have Insomnia Disorder. Sleep quality is also associated with risk factors for CVD. The objective of this study is to examine how insomnia contributes to CVD risk among people with PTSD. The investigators will also examine whether this risk can be decreased with treatment for Insomnia Disorder.

Conditions

Insomnia; Posttraumatic Stress Disorder; Cardiovascular Risk Factor

Outcome Measures

Primary Outcomes (14)

• Change in nighttime blood pressure

  Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.

  Baseline and post-treatment (approximately eight weeks)

• Change in nighttime blood pressure

  Nighttime systolic and diastolic blood pressure measured by 24-hour ambulatory blood pressure monitor.

  Baseline and 6-month follow-up

• Change in nighttime blood pressure dipping

  Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.

  Baseline and post-treatment (approximately eight weeks)

• Change in nighttime blood pressure dipping

  Systolic and diastolic blood pressure dipping measured by 24-hour ambulatory blood pressure monitoring, and defined as the percent change in blood pressure from the wake period to the nighttime sleep period.

  Baseline and 6-month follow-up

• Change in vascular endothelial function

  Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery. V

  Baseline and post-treatment (approximately eight weeks)

• Change in vascular endothelial function

  Vascular endothelial function will be measured by vascular ultrasound to determine flow mediated dilation (FMD) of the brachial artery.

  Baseline and 6-month follow-up

• Change in nighttime sympathetic nervous system activity

  Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.

  Baseline and post-treatment (approximately eight weeks)

• Change in nighttime sympathetic nervous system activity

  Measured by 24 hour urine collection (awake and sleep period collection separated) assayed for catecholamines (epinephrine, norepinephrine) and creatinine.

  Baseline and 6-month follow-up

• Change in 10-year atherosclerotic cardiovascular disease risk

  The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.

  Baseline and post-treatment (approximately eight weeks)

• Change in 10-year atherosclerotic cardiovascular disease risk

  The risk of having a primary atherosclerotic cardiovascular disease event within 10 years will be based upon the pooled cohort equations model developed by the American College of Cardiology/American Heart Association.

  Baseline and 6-month follow-up

• Change in insomnia severity

  Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.

  Baseline and post-treatment (approximately eight weeks)

• Change in insomnia severity

  Insomnia measured by the Insomnia Severity Index. The measure has a score range from 0 to 28, with higher scores indicating more severe insomnia.

  Baseline and 6-month follow-up

• Change in sleep efficiency

  Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.

  Baseline and post-treatment (approximately eight weeks)

• Change in sleep efficiency

  Sleep efficiency (percent-time asleep during the sleep period) measured by sleep diary and wrist actigraphy.

  Baseline and 6-month follow-up

Secondary Outcomes (4)

• Change in subjective sleep quality

  Baseline and 6-month follow-up

• Change in subjective sleep quality

  Baseline and post-treatment (approximately eight weeks)

• Change in quality of life

  Baseline and 6-month follow-up

• Change in quality of life

  Baseline and post-treatment (approximately eight weeks)

Study Arms (2)

Cognitive Behavior Therapy for Insomnia (CBT-I)

EXPERIMENTAL

Participants assigned to this arm will receive eight sessions of a well-established, evidence-based therapy called cognitive behavior therapy for insomnia (CBT-I).

Behavioral: Cognitive Behavior Therapy for Insomnia

Minimal Contact Control Condition

OTHER

Participants assigned to this condition will be contacted every week for eight weeks and monitored regarding their insomnia symptoms.

Behavioral: Weekly phone contacts

Interventions

Weekly phone contacts BEHAVIORAL

Weekly calls to monitor insomnia symptoms.

Minimal Contact Control Condition

Cognitive Behavior Therapy for Insomnia BEHAVIORAL

8 sessions of treatment for insomnia.

Also known as: CBT-I

Cognitive Behavior Therapy for Insomnia (CBT-I)

Eligibility Criteria

• Age: 40 Years - 59 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Is between 40-59 years old;
• Has a current diagnosis of chronic PTSD (at least 3 months duration) based on the Clinician Administered PTSD Scale DSM-5 version (Weathers et al., 2013);
• Has a current diagnosis of ID as defined in the International Classification of Sleep Disorders (ICSD-3; American Academy of Sleep Medicine, 2014)

You may not qualify if:

• Has a history of CVD events, including myocardial infarction, stroke, transient ischemic attack, or coronary revascularization;
• Has diagnosis of congestive heart failure or coronary artery disease based on results of diagnostic testing;
• Has a current alcohol use or substance use disorder (those who meet lifetime but not current alcohol or substance use disorder will be included);
• Is currently participating in or has recently (past 6 months) participated in an evidence-based trauma focused therapy for PTSD;
• Has cognitive impairment as evidenced by less than 20 on the Montreal Cognitive Assessment scale (M0CA; Nasreddine et al., 2005);
• Meets criteria for a psychotic spectrum disorder or bipolar disorder;
• Has severely impaired hearing or speech;
• Is pregnant;
• Does not use benzodiazepines for sleep, and if prescribed benzodiazepines for some other use (e.g., anxiety, panic attacks), uses them fewer than four times in a one month period.;
• Is not stable (medications and dose stable for one month) on any other current psychoactive and/or cardiovascular medications or will not be stable on these medications during the course of the study;
• Works night shift;
• Is participating in another interventional study to address insomnia;
• Has prominent suicidal or homicidal ideation (as assessed through a clinical interview);
• Has a serious/terminal illness or other health problem that would prohibit participation in the study;
• Has nonclinically significant or sub-threshold insomnia as indicated by a score of \<8 on the Insomnia Severity Index;

Sponsors & Collaborators

• Duke University: lead

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27706, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic

Interventions

Cognitive Behavioral Therapy

Condition Hierarchy (Ancestors)

Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Jean C Beckham, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

• Andrew Sherwood, PhD

  Duke Health

  PRINCIPAL INVESTIGATOR

Study Design

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

Model Details: Participants who are originally assigned to the minimal contact control condition will be invited to receive the active condition treatment after their study involvement has been completed, but no additional data will be collected from them.

Study Record Dates

• First Submitted: July 30, 2020
• First Posted: August 4, 2020
• Study Start: March 15, 2021
• Primary Completion: March 9, 2026
• Study Completion: March 9, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)