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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:
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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neurofeedback T4-P4 | Experimental | 40 sessions of SMR neurofeedback training using T4-P4 placement administered twice weekly |
|
| Neurofeedback T3-T4 | Active Comparator | 40 sessions of SMR neurofeedback using T3-T4 placement training administered twice weekly |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| neurofeedback | Behavioral | Operant conditioning of the EEG provided by computer reinforcement. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Davidson Trauma Scale Score | This is a well validated self-report measure of PTSD with clinical reference norms for adults. | 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) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Bessel van der Kolk, M.D. | Justice Resource Institute | Principal Investigator |
| Mark Gapen, Ph.D. | Justice Resource Institute | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| the Trauma Center at JRI | Brookline | Massachusetts | 02446 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26782083 | Background | 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. |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D058765 | Neurofeedback |
| ID | Term |
|---|---|
| D001676 | Biofeedback, Psychology |
| D026441 | Mind-Body Therapies |
| D000529 | Complementary Therapies |
| D013812 | Therapeutics |
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EEG Biofeedback versus wait list control condition.
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| 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. | 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) |
| D001521 |
| Behavior Therapy |
| D011613 | Psychotherapy |
| D004191 | Behavioral Disciplines and Activities |
| D030141 | Feedback, Psychological |