Dissociation, Emotional Regulation, Mood Disturbance, Post Traumatic Stress Symptoms, Well-Being, Psychological
Conditions
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.
Interventions
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.
Sponsors
Wayne State University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
OTHER
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No
Inclusion criteria
1. 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. 2. having self-reported symptoms of OCD; 3. 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; 4. being age 18+. 5. being a citizen of the United States of America -
Exclusion criteria
1. 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; 2. a documented history of epilepsy; 3. lifetime history of any head injury with loss of consciousness; 4. current exposure domestic or intimate partner violence or otherwise state that their current living conditions are unsafe; 5. current experiences of psychosis or suicidality within the last six months; 6. currently taking, or in the past month has taken benzodiazepines, narcotic drugs, or cannabis; 7. currently pregnant 8. engagement in self-harming behaviors in the last 3 months that required medical attention; 9. lack of competence to understand or consent to the study procedures; 10. lack of fluency in written and spoken English. -
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-Traumatic Stress Disorder Checklist for the Diagnostic and Statistical Manual of Mental Disorders, Fith Edition (PTSD Checklist for DSM-5 - Standard). | 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) | 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) | 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) | 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) | 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) | 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 | 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 | 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. |
Countries
United States
Contacts
CONTACTLisa S Panisch, PhD
Outcome results
None listed