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InsomniaNCT01920451

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

A study testing Cognitive-Behavioral Therapy for Insomnia (CBTI) in people with Insomnia and Posttraumatic Stress Disorder, run by Durham VA Medical Center at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 21 to 65 years
What is being tested?
Cognitive-Behavioral Therapy for Insomnia (CBTI)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
19 participants
Where
1 siteUnited States
Study dates
Aug 2013to Aug 2014
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 21 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • Durham VA Medical Center

    Durham, North Carolina, 27705

Other trials in United States

About this study

Official title: Is Reduced Blood Pressure a Consequence of Improved Sleep in Veterans With PTSD?

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.

Read the 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.

Being tested
Cognitive-Behavioral Therapy for Insomnia (CBTI)
Keywords
sleep, insomnia, posttraumatic stress disorder, hypertension, cardiovascular disease
Medical subject headings
Sleep Initiation and Maintenance Disorders, Stress Disorders, Post-Traumatic, Hypertension, Cardiovascular Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Cognitive-Behavioral Therapy for Insomnia (CBTI)Behavioural

    See arm description.

Study groups in NCT01920451
Study groupRoleWhat they receive
Cognitive-Behavioral Therapy for InsomniaExperimentalCognitive-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.
Receives: Behavioral: Cognitive-Behavioral Therapy for Insomnia (CBTI)
Wait ListNo interventionStudy 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Blood Pressure

    Change in both systolic and diastolic blood pressure from baseline to both post-intervention and 3 month follow-up.

    Measured: 3 months

Secondary outcomes (1)
  1. Heart Rate Variability

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

    Measured: 3 Months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2013 (estimated)
  2. Study startAug 2013
  3. Primary completionAug 2014
  4. Study completionAug 2014

Why it stopped: PI started new position.

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
19 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01920451
Sponsor's protocol ID
01584
Status last verified
Aug 2014
First submitted
8 Aug 2013
Last updated
6 Aug 2014
Results posted
No
Data monitoring committee
No

Questions about this trial

What is this clinical trial studying?

A study testing Cognitive-Behavioral Therapy for Insomnia (CBTI) in people with Insomnia and Posttraumatic Stress Disorder, run by Durham VA Medical Center at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Aug 2014. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study was stopped early (reason given: PI started new position.). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Blood Pressure (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Aug 2014.

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