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NCT Number: NCT07217925

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

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.

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Key information

Conditions

Well-Being, Psychological Behavior Dissociation Dissociative Disorders Emotional Regulation Mental Disorders Mood Disturbance Personal Satisfaction Post Traumatic Stress Symptoms Psychological Well-Being Self-Control Social Behavior

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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. -

Treatment and study plan

Neuroptimal (Zengar, Inc.) Neurofeedback

Device

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 outcomes

  1. 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.

    This measure evaluates symptoms of post-traumatic stress. Minimum score = 0 Maximum score = 80 Higher scores mean a worse outcome.

  2. 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.

    This 20-item measure evaluates moderate to severe levels of dissociative symptoms in four main domains: depersonalization, derealization, gaps in awareness or memory, and dissociative reexperiencing symptoms. Scores range from 0-80, with higher scores indicating worse outcomes.

  3. 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.

    10-item measure evaluating severity of obsessive compulsive symptoms, with an accompanying checklist of symptom types. Scores range from 0-40 with higher scores indicating worse outcomes. Symptoms on the checklist are categorized, and indicate different OCD symptom clusters or sub-types that respondents may experience.

  4. 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.

    36-item measure evaluating challenges with emotional regulation. Scores range from 36-180, with higher scores indicating worse outcomes.

  5. 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.

    5-item measure evaluating overall well-being. Scores range from 0-25, with higher scores indicating better outcomes.

  6. 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.

    8-item measure evaluating depressive symptoms. Scores range from 0-24, with higher scores indicating worse outcomes.

  7. 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.

    7-item measure evaluating anxiety symptoms. Scores range from 0-21, with higher scores indicating worse outcomes.

  8. 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.

    9-item measure evaluating experiences of discrimination. Scores range from 9-54, with higher scores indicating more frequent experiences of discrimination.

Sponsors and collaborators

Lead sponsor

Wayne State University

Other

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2027
Study completion
2029
First posted
Oct 20, 2025
Registry last updated
Nov 12, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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