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Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans (HRVB)

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ClinicalTrials.gov Identifier: NCT00625105
Recruitment Status : Unknown
Verified November 2014 by J.P. Ginsberg, Ph.D., William Jennings Bryan Dorn VA Medical Center.
Recruitment status was:  Active, not recruiting
First Posted : February 28, 2008
Last Update Posted : November 7, 2014
Sponsor:
Collaborator:
Congressionally Directed Medical Research Programs
Information provided by (Responsible Party):
J.P. Ginsberg, Ph.D., William Jennings Bryan Dorn VA Medical Center

Brief Summary:
This study will test the effectiveness of Heart Rate Variability (HRV) Biofeedback as a therapeutic tool in the reduction of everyday memory problems routinely experienced by combat veterans with Posttraumatic Stress Disorder (PTSD). The study is innovative in three ways: (1) through its investigation of the clinical use of a novel PTSD treatment technology, (2) by focusing on the understudied aspect of the daily functioning of PTSD veterans, and, (3) by investigating a heretofore untested application of biofeedback for PTSD induced deficits in attention (ATTN) and immediate memory (IM). Though HRV Biofeedback has proven successful for several applications in the general population, the idea that deficits in ATTN/IM in combat veterans with PTSD can be remedied by normalization of HRV has not yet been tested empirically. HRV is functionally incorporated into attentional processes, essentially operating as an index of autonomic flexibility and the ability to self-regulate in response to stimulation from the environment. Low HRV occurs in patients with PTSD, General Anxiety Disorder, and Coronary Artery Disease, and is correlated with negative affect and hostility. HRV Biofeedback training has been shown to be effective in increasing HRV in these groups of patients, as well as improving psychological well-being and physiological function in patients with Depression, Fibromyalgia, and Cardiovascular Disease. Therefore, the interrelationship between HRV and ATTN/IM problems in PTSD+ Combat veterans warrants further investigation. If HRV Biofeedback significantly improves ATTN/IM in these subjects, then it can be offered to VA clinicians treating combat PTSD as an effective new treatment tool.

Condition or disease Intervention/treatment Phase
PTSD Behavioral: Biofeedback Not Applicable

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans
Study Start Date : January 2011
Estimated Primary Completion Date : December 2014
Estimated Study Completion Date : December 2014

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Memory
U.S. FDA Resources

Arm Intervention/treatment
Active Comparator: Biofeedback
HRV coherence biofeedback procedure
Behavioral: Biofeedback
Sham Comparator: Sham intervention
Passive monitor viewing
Behavioral: Biofeedback



Primary Outcome Measures :
  1. Heart rate variability [ Time Frame: completion ]
  2. Attention and immediate memory [ Time Frame: completion ]


Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 40 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • OIF/OEF veterans with PTSD

Exclusion Criteria:

  • Neurologic disorder
  • Active substance abuse

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00625105


Locations
United States, South Carolina
Dorn VA Medical Center
Columbia, South Carolina, United States, 29209
Sponsors and Collaborators
William Jennings Bryan Dorn VA Medical Center
Congressionally Directed Medical Research Programs

Responsible Party: J.P. Ginsberg, Ph.D., Principal Investigator, William Jennings Bryan Dorn VA Medical Center
ClinicalTrials.gov Identifier: NCT00625105     History of Changes
Other Study ID Numbers: JPG001
First Posted: February 28, 2008    Key Record Dates
Last Update Posted: November 7, 2014
Last Verified: November 2014