EEG Biofeedback in the Treatment of Chronic Treatment-Resistant PTSD
Condition: Posttraumatic Stress Disorder
MeSH terms: Stress Disorders, Post-Traumatic
Study type: Interventional

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.
    

Intervention name(s): neurofeedback
Intervention type(s): Behavioral
Intervention description(s): Operant conditioning of the EEG provided by computer reinforcement.
Other intervention name(s): EEG Spectrum International; Thought Technologies; ProComp 2
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: EEG Biofeedback versus wait list control condition.
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment
Keywords: EEG biofeedback; neurofeedback; PTSD; Affect Regulation; Chronic Trauma