EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD

NCT01259921 | Completed

• 1 other identifier: ANS2008-06
• Study Type: interventional
• Target: 52
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine whether neurofeedback (NF) training can significantly reduce the symptoms of Posttraumatic Stress Disorder (PTSD) in individuals with significant affect dysregulation and chronic, treatment-resistant PTSD. The primary aims of this study include:

1. 1.To examine whether NF has the potential to significantly reduce symptoms of PTSD.
2. 2.To examine whether NF training can specifically target the area of affect regulation.
3. 3.To examine the mechanism of NF through elucidating the relationship between affect regulation and PTSD symptom change.

Conditions

Posttraumatic Stress Disorder

Keywords

EEG biofeedback; neurofeedback; PTSD; Affect Regulation; Chronic Trauma

Outcome Measures

Primary Outcomes (1)

• Change in Clinician Administered PTSD Scale Score

  The CAPS is considered the gold standard for the assessment of PTSD (National Center for PTSD Research). It is a clinician administered 30-item interview that corresponds to DSM-IV criteria for PTSD. Each item of the CAPS has two parts, frequency and intensity, which are both scored on a 5-point scale from 0 to 4. A general cut-off rule of frequency greater than or equal to 1 and intensity greater than or equal to 2 for a symptom to count towards diagnosis will be employed in assigning PTSD diagnosis.

  Participants are assessed at baseline (prior to beginning training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)

Secondary Outcomes (2)

• Change in Davidson Trauma Scale Score

  Participants are assessed at baseline (prior to beginning training), every 4 weeks (corresponding to 8 sessions of training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)

• Change in Inventory of Altered Self-Capacities Score

  Participants are assessed at baseline (prior to beginning training), every 4 weeks (corresponding to 8 sessions of training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment)

Study Arms (2)

Neurofeedback T4-P4

EXPERIMENTAL

40 sessions of SMR neurofeedback training using T4-P4 placement administered twice weekly

Behavioral: neurofeedback

Neurofeedback T3-T4

ACTIVE COMPARATOR

40 sessions of SMR neurofeedback using T3-T4 placement training administered twice weekly

Behavioral: neurofeedback

Interventions

neurofeedback BEHAVIORAL

Operant conditioning of the EEG provided by computer reinforcement.

Also known as: EEG Spectrum International, Thought Technologies, ProComp 2

Neurofeedback T3-T4; Neurofeedback T4-P4

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• CAPS score of 60 or over
• t-score of 70 or over on the affect dysregulation subscale of the IASC; AND
• Treatment-unresponsiveness as defined by having had at least 3 years of prior treatment focused on dealing with the consequences of the index trauma, or having been in treatment with more than three providers during the preceding decade

You may not qualify if:

• Serious non-stable medical illness
• GAF \< 40
• Bipolar disorder, obsessive-compulsive disorder (OCD), schizophrenia, and other psychotic disorder, or documented organic impairment
• Active suicidal risk, self-injury or physical aggression toward others within the past year
• Substance dependence or abuse in the past 6 months, as defined by DSM IV criteria
• Individuals taking a benzodiazepine more than twice per week (non-response seen in pilot work) AND
• Any other condition that might interfere with the person's capacity to give informed consent, or to adhere to the study protocol

Sponsors & Collaborators

• Justice Resource Institute: lead

Study Sites (1)

the Trauma Center at JRI

Brookline, Massachusetts, 02446, United States

Location

Related Publications (1)

• Gapen M, van der Kolk BA, Hamlin E, Hirshberg L, Suvak M, Spinazzola J. A Pilot Study of Neurofeedback for Chronic PTSD. Appl Psychophysiol Biofeedback. 2016 Sep;41(3):251-61. doi: 10.1007/s10484-015-9326-5.

  PMID: 26782083 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

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

Study Officials

• Bessel van der Kolk, M.D.

  Justice Resource Institute

  PRINCIPAL INVESTIGATOR

• Mark Gapen, Ph.D.

  Justice Resource Institute

  STUDY DIRECTOR

Study Design

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

Model Details: EEG Biofeedback versus wait list control condition.

Study Record Dates

• First Submitted: December 13, 2010
• First Posted: December 14, 2010
• Study Start: December 1, 2009
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: August 15, 2019

Record last verified: 2011-06

Locations

US (1)