EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2011 by Justice Resource Institute.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Justice Resource Institute
ClinicalTrials.gov Identifier:
NCT01259921
First received: December 13, 2010
Last updated: June 27, 2011
Last verified: June 2011
  Purpose

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

Condition Intervention
Posttraumatic Stress Disorder
Behavioral: neurofeedback

Study Type: Interventional
Study Design: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Application of Neurofeedback as a Mechanism of Affect Regulation Treatment of Adults With Complex Adaptation to Chronic Interpersonal Trauma Exposure

Resource links provided by NLM:


Further study details as provided by Justice Resource Institute:

Primary Outcome Measures:
  • Change in Clinician Administered PTSD Scale Score [ Time Frame: Participants are assessed at baseline (prior to beginning training), post-treatment (corresponding to 20 weeks), and at follow-up (1 year post treatment) ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Change in Davidson Trauma Scale Score [ Time Frame: 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) ] [ Designated as safety issue: No ]
    This is a well validated self-report measure of PTSD with clinical reference norms for adults.

  • Change in Inventory of Altered Self-Capacities Score [ Time Frame: 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) ] [ Designated as safety issue: No ]
    The IASC is a 63-item standardized measure of disturbed functioning in relation to self and others. The IASC measures seven domains of functioning: Interpersonal Conflicts, Idealization-Disillusionment, Abandonment Concerns, Identity Impairment, Susceptibility to Influence, Affect Dysregulation, and Tension Reduction Activities.


Estimated Enrollment: 100
Study Start Date: December 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Neurofeedback
40 sessions of SMR neurofeedback training administered twice weekly
Behavioral: neurofeedback
Operant conditioning of the EEG provided by computer reinforcement.
Other Names:
  • EEG Spectrum International
  • Thought Technologies
  • ProComp 2

Detailed Description:

Deficits in affect regulation are associated with a high rate of treatment failure to well-established evidence-based treatments for Posttraumatic Stress Disorder (PTSD), and deficits in this domain are most frequently found in individuals with chronic treatment-resistant PTSD. Aside from one psychological treatment intervention for adult female survivors of child sexual abuse, no published study has targeted improving affect regulation in treatment refractory PTSD. The aim of this study is to test and refine EEG neurofeedback (NF) as an effective treatment for PTSD associated with high levels of affect dysregulation. We believe improved affect regulation will lead to an overall improvement in functioning by addressing deficits in executive functioning in PTSD.

Primary Aim: The primary goal of the research is to refine and evaluate NF training for adults with treatment-resistant PTSD, specifically targeting the domain of affect regulation. We will evaluate the following questions:

  1. Will NF decrease chronic PTSD symptoms in a treatment-resistant sample of adults with childhood onset PTSD, as measured with the CAPS and the DTS? Hypothesis 1: Subjects in the active treatment condition will show significantly greater decreases on the CAPS and DTS than subjects in the placebo condition.
  2. Will NF improve affect regulation, as measured by the IASC? Hypothesis 2: Subjects in the active treatment condition will show significantly greater improvement on the affect dysregulation subscale of the IASC than individuals in the placebo condition.
  3. Will affect regulation, as measured by the IASC, mediate the relationship of NF training and PTSD, as measured with the DTS? Hypothesis 3: The affect dysregulation subscale of the IASC will significantly mediate the relationship between NF and DTS scores while DTS scores will not significantly mediate affect dysregulation.
  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01259921

Locations
United States, Massachusetts
the Trauma Center at JRI
Brookline, Massachusetts, United States, 02446
Sponsors and Collaborators
Justice Resource Institute
Investigators
Principal Investigator: Bessel van der Kolk, M.D. Justice Resource Institute
Study Director: Mark Gapen, Ph.D. Justice Resource Institute
  More Information

No publications provided

Responsible Party: Bessel van der Kolk, Medical Director, The Trauma Center at JRI
ClinicalTrials.gov Identifier: NCT01259921     History of Changes
Other Study ID Numbers: ANS2008-06
Study First Received: December 13, 2010
Last Updated: June 27, 2011
Health Authority: United States: Institutional Review Board

Keywords provided by Justice Resource Institute:
EEG biofeedback
neurofeedback
PTSD
Affect Regulation
Chronic Trauma

Additional relevant MeSH terms:
Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Anxiety Disorders
Mental Disorders

ClinicalTrials.gov processed this record on April 23, 2014