About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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+.

Disqualifiers

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;

Trial design

Design model

Single group

Treatments tested in this trial

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.

Treatment groups

20 Participants

are divided into 1 treatment group

Group A: Neurofeedback TrainingOther 1 intervention

Trial outcomes

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).

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

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.

2

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.

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.

3

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.

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.

4

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.

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.

Locations

This trial has no locations.

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

About this trial

Eligibility criteria

Qualifiers

Disqualifiers

Trial design

Treatments tested in this trial

Treatment groups

Trial outcomes

Primary outcomes

Secondary outcomes

Other outcomes

Locations

Sponsors and contacts