Blood Pressure, Heart Rate Variability & Sleep in Veterans With PTSD

This study has been terminated.
(PI started new position.)
Sponsor:
Information provided by (Responsible Party):
Christi Ulmer, Durham VA Medical Center
ClinicalTrials.gov Identifier:
NCT01920451
First received: August 8, 2013
Last updated: August 4, 2014
Last verified: August 2014
  Purpose

Sleep disturbance and posttraumatic stress disorder (PTSD) are common conditions in returning Veterans, and both conditions are known to increase the risk of cardiovascular disease. Research suggests that those with insomnia are at triple the risk of high blood pressure as compared to normal sleepers, and that having both insomnia and short sleep increases this risk to more than five times that of normal sleepers. These research findings suggest that recently deployed Veterans with insomnia may be at increased risk of developing high blood pressure, and this possibility is consistent with previous research. Vietnam era Veterans with combat-related PTSD assessed in 1985 were twice as likely to have died of early-onset heart disease relative to their non-PTSD counterparts when reassessed in 2000.

Evidence for impaired cardiac function in individuals with PTSD has been demonstrated across several studies as well. Compared to individuals without PTSD, those with PTSD seem to have lesser reaction to stress in terms of both heart rate and heart beat pattern. However, there has been very little research examining the impact of behavioral sleep interventions on health outcomes, and even fewer that are specific to a PTSD or Veteran population. The purpose of this study is to determine if treating insomnia results in improved blood pressure and cardiac function in recently deployed Veterans with PTSD. The findings of this research will serve as pilot data for a future grant application testing the efficacy of Cognitive-Behavioral Therapy for Insomnia (CBTI) for reducing cardiovascular risk in Veterans with PTSD using a full-scale randomized trial design. We are hypothesizing that improved sleep will be significantly associated with improved blood pressure and increased heart rate variability (improved autonomic function) in adults receiving CBTI compared to those in a wait-list control condition.


Condition Intervention
Insomnia
Posttraumatic Stress Disorder
Hypertension
Cardiovascular Disease
Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTI)

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Is Reduced Blood Pressure a Consequence of Improved Sleep in Veterans With PTSD?

Resource links provided by NLM:


Further study details as provided by Durham VA Medical Center:

Primary Outcome Measures:
  • Blood Pressure [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    Change in both systolic and diastolic blood pressure from baseline to both post-intervention and 3 month follow-up.


Secondary Outcome Measures:
  • Heart Rate Variability [ Time Frame: 3 Months ] [ Designated as safety issue: No ]
    Change in heart rate variability from baseline to both post-intervention and 3 month follow-up.


Enrollment: 19
Study Start Date: August 2013
Study Completion Date: August 2014
Primary Completion Date: August 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Cognitive-Behavioral Therapy for Insomnia
Cognitive-Behavioral Therapy for Insomnia (CBTI) consists of an an individually-tailored sleep prescription intended to consolidate fragmented sleep; guidance on changing learned associations that are harmful to sleep using stimulus control theory; education on standard sleep hygiene and to correct unrealistic sleep expectations; and the identification and restructuring of maladaptive thoughts and beliefs about sleep.
Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTI)
See arm description.
No Intervention: Wait List
Study participants who are randomized to the wait-list condition will not receive the intervention as part of this study protocol. They will, however, be offered the opportunity to receive CBTI at the end of their participation in this study. Wait-list participants will not be restricted in terms of additional therapies/treatments which they may seek for their sleep complaint.

Detailed Description:

Sleep disturbance is one of the most common complaints of recently deployed Veterans, with as many as 64% of those deployed to Iraq or Afghanistan returning with insomnia. The sleep complaints of these younger Veterans and military personnel are likely explained by a combination of factors, including: the sleep schedule variability required for military service; the vigilance necessary to remain alert in combat situations; and the sleep disturbance that stems directly from traumatic combat experiences; to name only a few. Among those deployed to Operation Enduring Freedom and Operation Iraqi Freedom (OEF/OIF/OND), up to 30% meet criteria for posttraumatic stress disorder (PTSD) upon their return or shortly thereafter, and most of these Veterans (up to 90%) are likely to endorse sleep maintenance problems. Indeed, PTSD often manifests as a combination of insomnia, short sleep duration, and nightmares.

There is a burgeoning literature showing an association between insomnia and hypertension, with some research suggesting that those with insomnia are at triple the risk of HTN relative to normal sleepers, and that the combination of insomnia and short sleep duration increases this risk to more than five times that of normal sleepers. These findings suggest that recently deployed Veterans with insomnia may be at increased risk of developing HTN, and research on Veterans from earlier eras of military service are consistent with this possibility. Vietnam era Veterans with combat-related PTSD assessed in 1985 were twice as likely to have died of early-onset heart disease relative to their non-PTSD counterparts when reassessed in 2000. In spite of these findings of significant sleep disturbance in young adults, and the historical evidence of increased cardiovascular disease in Vietnam-era Veterans with PTSD, data on sleep disturbance and blood pressure in this younger and ever-increasing population of recently deployed Veterans is lacking. Evidence for impaired cardiac function in individuals with PTSD has been demonstrated across several studies, including those examining heart rate variability (HRV). Individuals with PTSD have been found to have lower HRV and higher resting heart rate. The PI of the proposed study has conducted pilot research demonstrating that an intervention for trauma-related sleep disturbance improves sleep in Veterans with PTSD. The purpose of the proposed project is to further this line of research by determining if treating sleep disturbance improves blood pressure and heart rate variability in young adults with PTSD.

  Eligibility

Ages Eligible for Study:   21 Years to 65 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria: Eligible Veterans will: 1) provide informed consent; 2) be OEF/OIF/OND Veterans who were deployed to Iraq/Afghanistan at least once in a war zone; 3) meet DSM-IV-R criteria for a diagnosis of current PTSD; 4) endorse nightmares at a frequency of at least one per week; 5) meet DSM-5 diagnostic criteria for Insomnia; and 6) score greater than 14 on the Insomnia Severity Index.

Exclusion Criteria: Ineligible Veterans: 1) score <23 on the Montreal Cognitive Assessment (MoCA) suggesting inadequate cognitive abilities to successfully participate in this research; 2) have received CBT for insomnia in the past; 2) endorse a current diagnosis of sleep apnea; 3) Screen positive for Sleep Apnea on the STOP Questionnaire; 4) meet criteria for Bipolar Disorder (current or lifetime); 5) meet criteria for a Psychotic Disorder (Current); meet criteria for current Alcohol dependence; 6) meet criteria for current Substance Use Disorder or Substance Dependence; and 7) meet criteria for lifetime Substance Dependence.

  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01920451

Locations
United States, North Carolina
Durham VA Medical Center
Durham, North Carolina, United States, 27705
Sponsors and Collaborators
Durham VA Medical Center
Investigators
Principal Investigator: Christi S Ulmer, PhD Durham VAMC
  More Information

No publications provided

Responsible Party: Christi Ulmer, Clinical Research Psychologist, Durham VA Medical Center
ClinicalTrials.gov Identifier: NCT01920451     History of Changes
Other Study ID Numbers: 01584
Study First Received: August 8, 2013
Last Updated: August 4, 2014
Health Authority: United States: Federal Government

Keywords provided by Durham VA Medical Center:
sleep
insomnia
posttraumatic stress disorder
hypertension
cardiovascular disease

Additional relevant MeSH terms:
Cardiovascular Diseases
Hypertension
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Sleep Initiation and Maintenance Disorders
Vascular Diseases
Anxiety Disorders
Mental Disorders
Sleep Disorders, Intrinsic
Dyssomnias
Sleep Disorders
Nervous System Diseases

ClinicalTrials.gov processed this record on September 14, 2014