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

PTSD Clinical Trial

— HRVB  

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT00625105
• Other study ID #: JPG001
• Status: Active, not recruiting
• Phase: N/A
• First received: February 19, 2008
• Last updated: November 5, 2014
• Start date: January 2011
• Est. completion date: December 2014

Study information

• Verified date: November 2014
• Source: William Jennings Bryan Dorn VA Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: December 2014
• Est. primary completion date: December 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• OIF/OEF veterans with PTSD

Exclusion Criteria:

• Neurologic disorder

• Active substance abuse

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Factorial Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• PTSD

Intervention

Behavioral:
• Biofeedback

Locations

Country	Name	City	State
United States	Dorn VA Medical Center	Columbia	South Carolina

Sponsors (2)

Lead Sponsor	Collaborator
William Jennings Bryan Dorn VA Medical Center	Congressionally Directed Medical Research Programs

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Heart rate variability		completion	No
Primary	Attention and immediate memory		completion	No