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

NCT00625105 | Unknown DMC

• 1 other identifier: JPG001
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

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.

Conditions

PTSD

Outcome Measures

Primary Outcomes (2)

• Heart rate variability

  completion

• Attention and immediate memory

  completion

Study Arms (2)

Biofeedback

ACTIVE COMPARATOR

HRV coherence biofeedback procedure

Behavioral: Biofeedback

Sham intervention

SHAM COMPARATOR

Passive monitor viewing

Behavioral: Biofeedback

Interventions

Biofeedback BEHAVIORAL

Biofeedback; Sham intervention

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• OIF/OEF veterans with PTSD

You may not qualify if:

• Neurologic disorder
• Active substance abuse

Sponsors & Collaborators

• William Jennings Bryan Dorn VA Medical Center: lead
• Congressionally Directed Medical Research Programs: collaborator

Study Sites (1)

Dorn VA Medical Center

Columbia, South Carolina, 29209, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Biofeedback, Psychology

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: FACTORIAL
• Sponsor Type: FED
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 19, 2008
• First Posted: February 28, 2008
• Study Start: January 1, 2011
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: November 7, 2014

Record last verified: 2014-11

Locations

US (1)