EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD

Sponsor

Justice Resource Institute (Other)

Overall Status

Completed

CT.gov ID

NCT01259921

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

1.4

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Posttraumatic Stress Disorder	Behavioral: neurofeedback	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

52 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

EEG Biofeedback versus wait list control condition.EEG Biofeedback versus wait list control condition.

Masking:

Single (Outcomes Assessor)

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

Study Start Date :

Dec 1, 2009

Actual Primary Completion Date :

Dec 1, 2012

Actual Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Neurofeedback T4-P4 40 sessions of SMR neurofeedback training using T4-P4 placement administered twice weekly	Behavioral: neurofeedback Operant conditioning of the EEG provided by computer reinforcement. Other Names: EEG Spectrum International Thought Technologies ProComp 2
Active Comparator: Neurofeedback T3-T4 40 sessions of SMR neurofeedback using T3-T4 placement training administered twice weekly	Behavioral: neurofeedback Operant conditioning of the EEG provided by computer reinforcement. Other Names: EEG Spectrum International Thought Technologies ProComp 2

Arm

Intervention/Treatment

Experimental: Neurofeedback T4-P4

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

Behavioral: neurofeedback

Operant conditioning of the EEG provided by computer reinforcement.

Other Names:

EEG Spectrum International

Thought Technologies

ProComp 2

Active Comparator: Neurofeedback T3-T4

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

Behavioral: neurofeedback

Operant conditioning of the EEG provided by computer reinforcement.

Other Names:

EEG Spectrum International

Thought Technologies

ProComp 2

Outcome Measures

Primary Outcome Measures

Change in Clinician Administered PTSD Scale Score [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.

Secondary Outcome Measures

Change in Davidson Trauma Scale Score [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 [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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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