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

Primary Purpose

Insomnia, Posttraumatic Stress Disorder, Hypertension

Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Cognitive-Behavioral Therapy for Insomnia (CBTI)
Sponsored by
Durham VA Medical Center
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Insomnia focused on measuring sleep, insomnia, posttraumatic stress disorder, hypertension, cardiovascular disease

Eligibility Criteria

21 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Durham VA Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Cognitive-Behavioral Therapy for Insomnia

Wait List

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Blood Pressure
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
Change in heart rate variability from baseline to both post-intervention and 3 month follow-up.

Full Information

First Posted
August 8, 2013
Last Updated
August 4, 2014
Sponsor
Durham VA Medical Center
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1. Study Identification

Unique Protocol Identification Number
NCT01920451
Brief Title
Blood Pressure, Heart Rate Variability & Sleep in Veterans With PTSD
Official Title
Is Reduced Blood Pressure a Consequence of Improved Sleep in Veterans With PTSD?
Study Type
Interventional

2. Study Status

Record Verification Date
August 2014
Overall Recruitment Status
Terminated
Why Stopped
PI started new position.
Study Start Date
August 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
August 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Durham VA Medical Center

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insomnia, Posttraumatic Stress Disorder, Hypertension, Cardiovascular Disease
Keywords
sleep, insomnia, posttraumatic stress disorder, hypertension, cardiovascular disease

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
19 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cognitive-Behavioral Therapy for Insomnia
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List
Arm Type
No Intervention
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Cognitive-Behavioral Therapy for Insomnia (CBTI)
Intervention Description
See arm description.
Primary Outcome Measure Information:
Title
Blood Pressure
Description
Change in both systolic and diastolic blood pressure from baseline to both post-intervention and 3 month follow-up.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Heart Rate Variability
Description
Change in heart rate variability from baseline to both post-intervention and 3 month follow-up.
Time Frame
3 Months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
21 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christi S Ulmer, PhD
Organizational Affiliation
Durham VAMC
Official's Role
Principal Investigator
Facility Information:
Facility Name
Durham VA Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27705
Country
United States

12. IPD Sharing Statement

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

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