EEG Biofeedback Therapy as an Adjunct Treatment for PTSD

NCT01591408 | Completed Results DMC

• 1 other identifier: NMCSD.2012.0042
• Study Type: interventional
• Target: 68
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

PTSD; Anxiety; Trauma; Sleep Disorders

Keywords

EEG biofeedback; neurofeedback; therapy; adjunct

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

EEG biofeedback

EXPERIMENTAL

Subjects will receive EEG biofeedback according to their own brain rhythms

Device: EEG biofeedback

sham EEG biofeedback

SHAM COMPARATOR

Subjects will receive feedback according to someone else's brain rhythms collected during a different session.

Device: EEG biofeedback

Interventions

EEG biofeedback DEVICE

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.

Also known as: EEG info device

EEG biofeedback; sham EEG biofeedback

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Seizure disorder.

Sponsors & Collaborators

• United States Naval Medical Center, San Diego: lead
• Naval Health Research Center: collaborator

Study Sites (1)

OASIS PTSD program

San Diego, California, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Anxiety Disorders; Wounds and Injuries; Sleep Wake Disorders

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Nervous System Diseases; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Julie Onton
• Organization: NavalMCSD

julie.a.onton.ctr@mail.mil

619-553-6228

Study Officials

• Julie A Onton, PhD

  Naval Health Research Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 2, 2012
• First Posted: May 4, 2012
• Study Start: May 1, 2012
• Primary Completion: October 1, 2013
• Study Completion: October 1, 2013
• Last Updated: December 20, 2016
• Results First Posted: December 20, 2016

Record last verified: 2016-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)