Well-Being, PsychologicalNCT07217925
Neurofeedback and Well-Being Among People With Co-Occurring Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms
A study testing Neuroptimal (Zengar, Inc.) Neurofeedback in people with Well-Being, Psychological and Mood Disturbance, run by Wayne State University at 1 site in United States.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Well-Being, Psychological, Mood Disturbance, Emotional Regulation
- What is being tested?
- Neuroptimal (Zengar, Inc.) Neurofeedback
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2025to Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 -
Who cannot join
- 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;
Show all 10Show fewer
- 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. -
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Wayne State University
Detroit, Michigan, 48202
Lisa S
Lisa s Panisch, PhD
About this study
Official title: Exploring the Influence of Neurofeedback on the Well-Being of People With Symptoms of 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.
- Conditions
- Well-Being, Psychological, Mood Disturbance, Emotional Regulation, Dissociation, Post Traumatic Stress Symptoms
- Being tested
- Neuroptimal (Zengar, Inc.) Neurofeedback
- Medical subject headings
- Psychological Well-Being, Emotional Regulation, Dissociative Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Neuroptimal (Zengar, Inc.) NeurofeedbackDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Neuroptimal (Zengar, Inc.) Neurofeedback |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2025
- Study start1 Nov 2025
- Primary completionJun 2027 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Well-Being, PsychologicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Wayne State University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Lisa S. Panisch, PhD, MSW, Wayne State University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07217925
- Sponsor's protocol ID
- IRB-25-07-7918
- Status last verified
- Aug 2026
- First submitted
- 14 Oct 2025
- Last updated
- 19 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Exploring the Influence of Neurofeedback on the Well-Being of People With Symptoms of Obsessive Compulsive Disorder and Post-traumatic Stress Symptoms
- ClinicalTrials.gov ID
- NCT07217925
- Acronym / sponsor ID
- IRB-25-07-7918
- Conditions
- Well-Being, Psychological, Mood Disturbance, Emotional Regulation, Dissociation, Post Traumatic Stress Symptoms
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Wayne State UniversityUniversity, hospital or other
- Study start
- 1 Nov 2025 (actual)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 20 Oct 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Neurofeedback Training | Other | Device: Neuroptimal (Zengar, Inc.) NeurofeedbackParticipants 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. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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 -
Key exclusion criteria (10 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Neuroptimal (Zengar, Inc.) NeurofeedbackParticipants 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. | Device | Neurofeedback Training |
Primary outcome
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.
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.
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.
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.
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.
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.
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.
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Aug 2026.
Related trials for Well-Being, Psychological
Recruiting
Effect of a Brief Daily Digital Meditation on Well-Being in US Young Adults (BEGIN II)
Mental Health and General Well-being
Active, not recruiting
Intervention to Address Disparate Mental Health Consequences of COVID-19 Pandemic on Latinx and African Newcomers
Mental Health Issue, Mental Health Disorder
Not yet recruiting
REM Enhancement Sleep Technology for Well-being, Emotion, and Life Lift
Healthy Adult Participants
Recruiting
Effects of Red Panax Ginseng Supplementation on Cognitive Performance and Emotional Well-Being in Young Healthy Adults
Mental Acuity
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Neuroptimal (Zengar, Inc.) Neurofeedback in people with Well-Being, Psychological and Mood Disturbance, run by Wayne State University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 19 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa S Panisch, PhD (3135774409, hj1429@wayne.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Aug 2026.