EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD

NCT ID: NCT01259921

Last Updated: 2019-08-15

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 52 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-12-31
• Study Completion Date: 2012-12-31

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. 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.

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.

Conditions

Posttraumatic Stress Disorder

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

Neurofeedback T4-P4

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

Group Type: EXPERIMENTAL

neurofeedback

Intervention Type: BEHAVIORAL

Operant conditioning of the EEG provided by computer reinforcement.

Neurofeedback T3-T4

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

Group Type: ACTIVE_COMPARATOR

neurofeedback

Intervention Type: BEHAVIORAL

Operant conditioning of the EEG provided by computer reinforcement.

Interventions

neurofeedback

Operant conditioning of the EEG provided by computer reinforcement.

Intervention Type: BEHAVIORAL

Other Intervention Names

EEG Spectrum International; Thought Technologies; ProComp 2

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Justice Resource Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Bessel van der Kolk, M.D.

Role: PRINCIPAL_INVESTIGATOR

Justice Resource Institute

Mark Gapen, Ph.D.

Role: STUDY_DIRECTOR

Justice Resource Institute

Locations

the Trauma Center at JRI

Brookline, Massachusetts, United States

Countries

United States

References

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.

Reference Type: BACKGROUND

PMID: 26782083 (View on PubMed)

Other Identifiers

ANS2008-06

Identifier Type: -

Identifier Source: org_study_id