EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD
Primary Purpose
Posttraumatic Stress Disorder
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
neurofeedback
Sponsored by
About this trial
This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring EEG biofeedback, neurofeedback, PTSD, Affect Regulation, Chronic Trauma
Eligibility 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
Sites / Locations
- the Trauma Center at JRI
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Neurofeedback T4-P4
Neurofeedback T3-T4
Arm Description
40 sessions of SMR neurofeedback training using T4-P4 placement administered twice weekly
40 sessions of SMR neurofeedback using T3-T4 placement training administered twice weekly
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Change in Davidson Trauma Scale Score
This is a well validated self-report measure of PTSD with clinical reference norms for adults.
Change in Inventory of Altered Self-Capacities Score
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.
Full Information
NCT ID
NCT01259921
First Posted
December 13, 2010
Last Updated
August 13, 2019
Sponsor
Justice Resource Institute
1. Study Identification
Unique Protocol Identification Number
NCT01259921
Brief Title
EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD
Official Title
Application of Neurofeedback as a Mechanism of Affect Regulation Treatment of Adults With Complex Adaptation to Chronic Interpersonal Trauma Exposure
Study Type
Interventional
2. Study Status
Record Verification Date
June 2011
Overall Recruitment Status
Completed
Study Start Date
December 2009 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Justice Resource Institute
4. Oversight
Data Monitoring Committee
No
5. Study Description
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:
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.
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:
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
EEG biofeedback, neurofeedback, PTSD, Affect Regulation, Chronic Trauma
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
EEG Biofeedback versus wait list control condition.
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
52 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Neurofeedback T4-P4
Arm Type
Experimental
Arm Description
40 sessions of SMR neurofeedback training using T4-P4 placement administered twice weekly
Arm Title
Neurofeedback T3-T4
Arm Type
Active Comparator
Arm Description
40 sessions of SMR neurofeedback using T3-T4 placement training administered twice weekly
Intervention Type
Behavioral
Intervention Name(s)
neurofeedback
Other Intervention Name(s)
EEG Spectrum International, Thought Technologies, ProComp 2
Intervention Description
Operant conditioning of the EEG provided by computer reinforcement.
Primary Outcome Measure Information:
Title
Change in Clinician Administered PTSD Scale Score
Description
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.
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)
Secondary Outcome Measure Information:
Title
Change in Davidson Trauma Scale Score
Description
This is a well validated self-report measure of PTSD with clinical reference norms for adults.
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)
Title
Change in Inventory of Altered Self-Capacities Score
Description
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.
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)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bessel van der Kolk, M.D.
Organizational Affiliation
Justice Resource Institute
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Mark Gapen, Ph.D.
Organizational Affiliation
Justice Resource Institute
Official's Role
Study Director
Facility Information:
Facility Name
the Trauma Center at JRI
City
Brookline
State/Province
Massachusetts
ZIP/Postal Code
02446
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
26782083
Citation
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.
Results Reference
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EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD
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