EEG Biofeedback Therapy as an Adjunct Treatment for PTSD

Placebo-controlled Study of EEG Biofeedback Therapy as an Adjunct Treatment for PTSD, Evaluating Symptoms and EEG Dynamics

The proposed study, "Placebo-controlled study of EEG biofeedback therapy as an adjunct treatment for PTSD, evaluating symptoms and EEG dynamics", will investigate the brain dynamics associated with PTSD symptom reduction associated with EEG biofeedback therapy or sham EEG biofeedback in addition to treatment as usual at the Naval Medical Center, San Diego (NMCSD) OASIS program.

EEG biofeedback treatment protocols for PTSD and other disorders have been developed and honed by private practice clinicians over the past 25 years, during which EEG biofeedback has become an increasingly popular adjunct therapy.

The reported success of EEG biofeedback as a non-drug intervention with lasting efficacy warrants a clinical study investigating not only symptom reduction, but also the underlying neurobiological mechanism. To this end, we propose a study using high density EEG recordings before and after treatment for PTSD symptoms to determine which brain activities correlate with reported symptom changes.

The proposed study could expand treatment alternatives for servicemen with PTSD. If EEG biofeedback is shown to improve symptom reduction over the placebo controlled condition, it would offer a non-pharmacological intervention that would avoid undesirable side effects, and accelerate recovery compared with the current standard of care.

Study Overview

• Status: Completed
• Conditions: PTSD; Anxiety; Trauma; Sleep Disorders
• Intervention / Treatment: Device: EEG biofeedback

Detailed Description

EEG biofeedback is an emerging alternative approach to treating PTSD, for which there is still insufficient evidence to assume unequivocal clinical utility. However, a 1991 report showed PTSD symptom reduction in 14 subjects receiving EEG biofeedback, as compared to 13 subjects receiving traditional treatment (Peniston, 1991), and a recent case study of 2 PTSD patients receiving EEG biofeedback therapy also showed reduce symptom severity using a newer protocol and device (Othmer, 2009). Another recent study focused on the anxiety symptoms of PTSD and showed that EEG biofeedback significantly reduced anxiety compared to subjects not receiving treatment (Walker, 2009).

EEG biofeedback has also been explored as a treatment for non-PTSD related anxiety disorders, with results showing significant changes in reported anxiety correlated with increased or decreased alpha-frequency (~8-12 Hz) power (Hardt, 1978). Similarly, alpha-frequency EEG biofeedback has been shown to reduce anxiety and to reduce heart rate reactivity to a stressor after 8 sessions of EEG biofeedback training (Rice, 1993). While EEG biofeedback has been shown to significantly change EEG power dynamics (Egner, 2004), it is still unclear if and how EEG biofeedback can effect long-term and complex changes in cognitive and/or emotional functioning.

Some attention has been given to other types of biofeedback for the treatment for PTSD, such as heart rate variability (HRV) biofeedback, which may be relevant in understanding the background of biofeedback with respect to PTSD treatment. While one study reported no difference in symptom reduction between treatment as usual and treatment as usual plus HRV biofeedback (Lande, 2010), a handful of other studies have reported significant associations between HRV changes and PTSD symptoms. Specifically, increased HRV was significantly correlated with PTSD symptom reduction, which was more effective with respiratory sinus arrhythmia (RSA) (which affects HRV) biofeedback than with progressive muscle relaxation (Zucker, 2009). Furthermore, combat-related PTSD subjects showed lower resting HRV than controls, but training with HRV biofeedback increased PTSD subjects' HRV and simultaneously decreased their PTSD symptoms (Tan, 2011). Finally, a quantitative EEG study showed that an acute session of RSA biofeedback was associated with an increase in alpha-band power and reduced higher frequency beta-band power, suggesting a neural impact of RSA training and HRV regulation (Sherlin, 2010).

Summary The proposed study of EEG biofeedback at the OASIS program will not only address the clinical efficacy, but also the brain activations associated with specific symptoms of PTSD through collection of high-density EEG data before and after EEG biofeedback treatment. These data will help elucidate the neural correlates of PTSD symptom expression as well as address the potential efficacy of EEG biofeedback therapy as an adjunct treatment for PTSD-like symptoms.

• Study Type: Interventional
• Enrollment (Actual): 68
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • San Diego, California, United States
      • OASIS PTSD program

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Male

Description

Inclusion Criteria:

• Male,
• active military,
• participating in PTSD program at NMCSD

Exclusion Criteria:

• Seizure disorder.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: EEG biofeedback; Subjects will receive EEG biofeedback according to their own brain rhythms	Device: EEG biofeedback; EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.; Other Names: EEG info device
Sham Comparator: sham EEG biofeedback; Subjects will receive feedback according to someone else's brain rhythms collected during a different session.	Device: EEG biofeedback; EEG data is collected from the scalp. Data is decomposed in real time and a portion of the signal is fed back to the subject via a vibrating stuffed animal and visual cues.; Other Names: EEG info device

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improved Symptom Ratings	Will test whether subjects receiving real EEG biofeedback report decreased anxiety and irritability relative to subjects receiving sham biofeedback. The scale for each rating was a 0-10, with 0 meaning "not at all" and 10 being "extremely" anxious/irritable.	4 weeks

Collaborators and Investigators

• Sponsor: United States Naval Medical Center, San Diego
• Collaborators: Naval Health Research Center
• Investigators: Principal Investigator: Julie A Onton, PhD, Naval Health Research Center

Study record dates

Study Major Dates

• Study Start: May 1, 2012
• Primary Completion (Actual): October 1, 2013
• Study Completion (Actual): October 1, 2013

Study Registration Dates

• First Submitted: May 2, 2012
• First Submitted That Met QC Criteria: May 3, 2012
• First Posted (Estimate): May 4, 2012

Study Record Updates

• Last Update Posted (Estimate): December 20, 2016
• Last Update Submitted That Met QC Criteria: October 27, 2016
• Last Verified: October 1, 2016

More Information

Terms related to this study

• Keywords: neurofeedback; therapy; adjunct; EEG biofeedback
• Additional Relevant MeSH Terms: Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Sleep Wake Disorders
• Other Study ID Numbers: NMCSD.2012.0042

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No