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

This study is currently recruiting participants.
Verified December 2013 by William Jennings Bryan Dorn VA Medical Center
Sponsor:
Collaborator:
CDMRP (DoD)
Information provided by (Responsible Party):
J.P. Ginsberg, Ph.D., William Jennings Bryan Dorn VA Medical Center
ClinicalTrials.gov Identifier:
NCT00625105
First received: February 19, 2008
Last updated: December 17, 2013
Last verified: December 2013

February 19, 2008
December 17, 2013
January 2011
December 2013   (final data collection date for primary outcome measure)
  • Heart rate variability [ Time Frame: completion ] [ Designated as safety issue: No ]
  • Attention and immediate memory [ Time Frame: completion ] [ Designated as safety issue: No ]
Heart rate variability
Complete list of historical versions of study NCT00625105 on ClinicalTrials.gov Archive Site
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Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans
Using Heart Rate Variability Biofeedback to Improve Attention and Memory in PTSD+ Combat Veterans

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.

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Interventional
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Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
PTSD
Behavioral: Biofeedback
  • Active Comparator: Biofeedback
    HRV coherence biofeedback procedure
    Intervention: Behavioral: Biofeedback
  • Sham Comparator: Sham intervention
    Passive monitor viewing
    Intervention: Behavioral: Biofeedback
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
30
December 2013
December 2013   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • OIF/OEF veterans with PTSD

Exclusion Criteria:

  • Neurologic disorder
  • Active substance abuse
Both
20 Years to 40 Years
Yes
Contact: J.P. Ginsberg, Ph.D. 803.776.4000 ext 6634 jay.ginsberg@va.gov
United States
 
NCT00625105
JPG001
Yes
J.P. Ginsberg, Ph.D., William Jennings Bryan Dorn VA Medical Center
William Jennings Bryan Dorn VA Medical Center
CDMRP (DoD)
Not Provided
William Jennings Bryan Dorn VA Medical Center
December 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP