EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD
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|ClinicalTrials.gov Identifier: NCT01259921|
Recruitment Status : Unknown
Verified June 2011 by Justice Resource Institute.
Recruitment status was: Active, not recruiting
First Posted : December 14, 2010
Last Update Posted : June 29, 2011
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:
- To examine whether NF has the potential to significantly reduce symptoms of PTSD.
- To examine whether NF training can specifically target the area of affect regulation.
- To examine the mechanism of NF through elucidating the relationship between affect regulation and PTSD symptom change.
|Condition or disease||Intervention/treatment||Phase|
|Posttraumatic Stress Disorder||Behavioral: neurofeedback||Not Applicable|
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:
- 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.
- 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.
- 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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||100 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Application of Neurofeedback as a Mechanism of Affect Regulation Treatment of Adults With Complex Adaptation to Chronic Interpersonal Trauma Exposure|
|Study Start Date :||December 2009|
|Estimated Primary Completion Date :||December 2012|
|Estimated Study Completion Date :||December 2012|
40 sessions of SMR neurofeedback training administered twice weekly
Operant conditioning of the EEG provided by computer reinforcement.
- 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) ]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.
- 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) ]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) ]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.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01259921
|United States, Massachusetts|
|the Trauma Center at JRI|
|Brookline, Massachusetts, United States, 02446|
|Principal Investigator:||Bessel van der Kolk, M.D.||Justice Resource Institute|
|Study Director:||Mark Gapen, Ph.D.||Justice Resource Institute|