Neurofeedback and Well-Being Among People With Co-Occurring Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms

Official title

Exploring the Influence of Neurofeedback on the Well-Being of People With Symptoms of Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms

Overview

The proposed study will collect novel data evaluating the feasibility of a neurofeedback training program delivered to prospective clients with a history of clinically concerning trauma-related mental health symptoms who are on a wait list to receive obsessive compulsive disorder-specific psychotherapy at an outpatient mental health clinic. This study will evaluate the influence of neurofeedback training on participant's overall sense of well-being, and additionally, whether any enhanced well-being is subsequently associated with positive changes in symptoms of obsessive compulsive disorder, post-traumatic stress, dissociation and other trauma-related mental health symptoms, emotional regulation, etc.

Interventions

• Device Neuroptimal (Zengar, Inc.) Neurofeedback
  Participants in the Neurofeedback Training group will complete a total of 8 training sessions (1-2 sessions a week, each session lasting approximately 34 minutes) within a 3 month time span, using the Neuroptimal (Zengar, Inc.) neurofeedback device.

Primary outcome measures

• Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard). [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]
• Dissociative Symptoms Scale (DSS) [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]
• Yale-Brown Obsessive Compulsive Scale (Y-BOCS; with Checklist) [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]
• Difficulties in Emotion Regulation Scale (DERS) [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]
• The World Health Organization-Five Well-Being Index (WHO-5) [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]
• Patient Health Questionnaire - 8 (PHQ-8) [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]
• GAD-7 [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]
• Everyday Discrimination Scale [Time frame: The measure will be administered three intervals: 1) per-training, at the beginning of the study, 2) post-training, between 2-3 months later, following the completion of the training phase, 3) as a follow-up, 3 months after the post-training interval.]

Eligibility criteria

Inclusion criteria

• being a client placed on the clinic waitlist to receive exposure-response prevention for OCD symptoms at the Anxiety and OCD Treatment Center of Ann Arbor, in Ann Arbor, MI.
• having self-reported symptoms of OCD;
• having post-traumatic stress symptoms as indicated by a score of 3 or higher on the Primary Care PTSD Screen for DSM-5 (PC-PTSD-5) screening measure;
• being age 18+.
• being a citizen of the United States of America -

Exclusion criteria

• a lifetime history of significant untreated mental illness (not currently treated schizophrenia, schizoaffective disorder, bipolar disorder, or substance use disorder) or neurological or pervasive developmental disorder;
• a documented history of epilepsy;
• lifetime history of any head injury with loss of consciousness;
• current exposure domestic or intimate partner violence or otherwise state that their current living conditions are unsafe;
• current experiences of psychosis or suicidality within the last six months;
• currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis;
• currently pregnant
• engagement in self-harming behaviors in the last 3 months that required medical attention;
• lack of competence to understand or consent to the study procedures;
• lack of fluency in written and spoken English. -

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Other

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07217925 · IRB-25-07-7918

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗