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

NCT07217925 | Not Yet Recruiting FDA Device

• 1 other identifier: IRB-25-07-7918
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

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.

Conditions

Well-Being, Psychological; Mood Disturbance; Emotional Regulation; Dissociation; Post Traumatic Stress Symptoms

Outcome Measures

Primary Outcomes (8)

• Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard).

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

  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)

  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.

  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)

  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.

  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)

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

  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)

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

  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)

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

  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

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

  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

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

  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.

Study Arms (1)

Neurofeedback Training

OTHER

Participants in the Neurofeedback Training group will complete per-training, post-training, and post-training follow-up self-report surveys assessing overall well-being, symptoms of obsessive compulsive disorder, post-traumatic stress, OCD, dissociation and other trauma-related mental health symptoms, emotional regulation, etc. Participants in this group will all be on a wait list to receive obsessive compulsive disorder-specific psychotherapy at a local outpatient therapy clinic that specializes in the treatment of anxiety and obsessive compulsive disorders. All participants will demonstrate clinically significant post-traumatic stress symptoms and have a self-reported diagnosis of obsessive compulsive disorder.

Device: Neuroptimal (Zengar, Inc.) Neurofeedback

Interventions

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.

Neurofeedback Training

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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 -

You may not qualify if:

• 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. -

Sponsors & Collaborators

• Wayne State University: lead

MeSH Terms

Conditions

Psychological Well-Being; Emotional Regulation; Dissociative Disorders

Interventions

Neurofeedback

Condition Hierarchy (Ancestors)

Personal Satisfaction; Behavior; Self-Control; Social Behavior; Mental Disorders

Intervention Hierarchy (Ancestors)

Biofeedback, Psychology; Mind-Body Therapies; Complementary Therapies; Therapeutics; Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Feedback, Psychological

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: OTHER
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: October 14, 2025
• First Posted: October 20, 2025
• Study Start: November 1, 2025
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): January 1, 2029
• Last Updated: November 12, 2025

Record last verified: 2025-11