grant

An evaluation of insomnia treatment to reduce cardiovascular risk in patients with posttraumatic stress disorder

Organization DUKE UNIVERSITYLocation DURHAM, UNITED STATESPosted 1 Jul 2020Deadline 30 Jun 2026
NIHUS FederalResearch GrantFY202421+ years oldActive Follow-upAddressAdultAdult HumanAlcohol abuseAmbulatory Blood Pressure MonitoringArousalAtherosclerosisAtherosclerotic Cardiovascular DiseaseBehavioralBiological MarkersBlood PressureCardiovascular DiseasesCatecholaminesChronicCognition TherapyCognitive PsychotherapyCognitive TherapyCognitive treatmentComorbid InsomniaDataDevelopmentDisablingDrugsEtOH abuseEvaluationEventExposure toGoalsHealth behaviorHeterogeneityHourIndividualInsomniaInsomnia DisorderInterventionIntervention StrategiesKnowledgeLinkLipidsMeasurementMeasuresMediatingMedicalMedicationMental DepressionMental disordersMental health disordersMinority StatusMorbidityMorbidity - disease rateOutcomePTSDPatient Self-ReportPatientsPersonsPharmaceutical PreparationsPhenotypePopulationPost-Traumatic NeurosesPost-Traumatic Stress DisordersPosttraumatic NeurosesProspective StudiesPsychiatric DiseasePsychiatric DisorderPsychotherapyQOLQuality IndicatorQuality of lifeRandomizedResearchRiskRisk FactorsSelf-ReportSeveritiesSleepSleep DisordersSleep disturbancesSleeplessnessSympathetic Nervous SystemSympathinsSymptomsTestingTherapeuticTimeTraumaVascular EndotheliumWomanWorkaberrant sleepactigraphactigraphyactive followupadulthoodalcohol co-abusealcohol problemarmassociated symptomatheromatosisatherosclerosis riskatherosclerotic diseaseatherosclerotic riskatherosclerotic vascular diseasebehavioral sleep health interventionbehavioral sleep health programbehavioral sleep interventionbehavioral sleep strategiesbehavioral sleep therapybehavioral sleep treatmentbio-markersbiologic markerbiological sexbiomarkerbrachial arterycardiovascular disease riskcardiovascular disordercardiovascular disorder riskcardiovascular riskcardiovascular risk factorcigarette smokingcigarette useco-morbidco-morbid insomniaco-morbid symptomco-morbidityco-occuring symptomcognitive behavior interventioncognitive behavior modificationcognitive behavior therapycognitive behavioral interventioncognitive behavioral modificationcognitive behavioral therapycognitive behavioral treatmentcomorbid symptomcomorbiditycompare to controlcomparison controlconcurrent symptomcooccuring symptomcostdepressiondesigndesigningdevelopmentaldisrupted sleepdisturbed sleepdrug adherencedrug compliancedrug/agentethanol abuseevidence basefollow upfollow-upfollowed upfollowuphazardous alcohol usehealth related behaviorimpaired sleepimprovedimprovement on sleepindexinginnovateinnovationinnovativeinterestinterventional strategyirregular sleepmedication adherencemedication compliancemenmental illnessmid lifemid-lifemiddle agemiddle agedmidlifemortalitymulti-modalitymultimodalitypoor sleeppost interventionpost-trauma stress disorderposttrauma stress disorderproblem alcohol useproblem drinkingproblematic alcohol consumptionproblematic alcohol usepsychiatric co-morbiditypsychiatric comorbiditypsychiatric illnesspsychological disorderquality of sleeprandomisationrandomizationrandomly assignedresponseresponse to therapyresponse to treatmentsleep diseasessleep disruptionsleep dysfunctionsleep dysregulationsleep illnesssleep improvementsleep onsetsleep problemsleep qualitysymptom associationsymptom comorbiditytherapeutic responsetherapy responsetraumatic eventtraumatic neurosistreatment responsetreatment responsivenessurinary
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Full Description

Posttraumatic stress disorder (PTSD) is a disabling and costly psychiatric disorder that is estimated to occur in
20% of individuals who are exposed to a traumatic event and is chronic in one third of cases. In addition to its

negative impact on quality of life, there is substantial evidence that PTSD (even after controlling for depression

and other risk factors) is associated with a markedly increased risk of cardiovascular morbidity and mortality.

However, the mechanisms for the association between PTSD and cardiovascular disease (CVD) risk are not well

understood. Although adverse health behaviors, including cigarette smoking, alcohol abuse and poor medication

adherence are common in PTSD, recent prospective studies show that they do not account for the magnitude of

CVD risk among individuals with PTSD. We propose to test our central hypothesis by evaluating whether CBT-I

results in improved biomarkers of CVD risk among those with PTSD. Well established biomarkers of CVD related

morbidity and mortality will be used including measures of vascular endothelial function measured by brachial

artery flow-mediated dilation (FMD), nighttime blood pressure (BP) dipping measured using 24-hour ambulatory

blood pressure monitoring (ABPM), and sympathetic nervous system (SNS) activity as measured by 24-hour

urinary catecholamines. We will also assess lipid profile, which along with BP is a modifiable component with

marked impact on the atherosclerotic cardiovascular disease (ASCVD) risk score. The primary sleep parameter of

interest is objectively-measured sleep efficiency (through actigraphy), although self-report insomnia measures and

sleep related arousal will also be measured. The rationale for the proposed research is that once it is established

that insomnia is an important and modifiable symptom conveying increased CVD risk in this population, the

development of new and innovative approaches to integrating insomnia treatment with PTSD-focused

interventions can be developed. 150 men and women with comorbid PTSD and insomnia disorder will be

randomly assigned with a 2:1 ratio to 8-week cognitive behavioral therapy-Insomnia (CBT-I) intervention or a

waiting period control condition. Sleep quality parameters and CVD risk biomarkers will be assessed at pre-

randomization baseline, post-intervention, and at a 6-month follow-up. The study is designed to evaluate the

association between insomnia and CVD risk biomarkers among persons with PTSD, and determine whether

improvements in insomnia symptoms are associated with improvements in CVD risk biomarkers.

Grant Number: 5R01HL148327-05
NIH Institute/Center: NIH

Principal Investigator: JEAN BECKHAM

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