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

NCT01920451 | Terminated

• 1 other identifier: 01584
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

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.

Conditions

Insomnia; Posttraumatic Stress Disorder; Hypertension; Cardiovascular Disease

Keywords

sleep; insomnia; posttraumatic stress disorder; hypertension; cardiovascular disease

Outcome Measures

Primary Outcomes (1)

• Blood Pressure

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

  3 months

Secondary Outcomes (1)

• Heart Rate Variability

  3 Months

Study Arms (2)

Cognitive-Behavioral Therapy for Insomnia

EXPERIMENTAL

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)

Wait List

NO INTERVENTION

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.

Interventions

Cognitive-Behavioral Therapy for Insomnia (CBTI) BEHAVIORAL

See arm description.

Cognitive-Behavioral Therapy for Insomnia

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

Sponsors & Collaborators

• Durham VA Medical Center: lead

Study Sites (1)

Durham VA Medical Center

Durham, North Carolina, 27705, United States

Location

MeSH Terms

Conditions

Sleep Initiation and Maintenance Disorders; Stress Disorders, Post-Traumatic; Hypertension; Cardiovascular Diseases

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; Vascular Diseases

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities

Study Officials

• Christi S Ulmer, PhD

  Durham VAMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Research Psychologist

Study Record Dates

• First Submitted: August 8, 2013
• First Posted: August 12, 2013
• Study Start: August 1, 2013
• Primary Completion: August 1, 2014
• Study Completion: August 1, 2014
• Last Updated: August 6, 2014

Record last verified: 2014-08

Locations

US (1)