Post-traumatic Stress Disorder Clinical Trial
— NEUROFEEDPTSDOfficial title:
A Virtual World/Neurofeedback Real Time Functional MRI Approach to PTSD Treatment
Verified date | November 2020 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
A commonly used therapy for post-traumatic stress disorder (PTSD) that often (but not always) gives good results is "exposure therapy": When the patient (for example, Veterans who have attacks of anxiety when a noise startles them) talks about the trauma that precipitated the PTSD, she or he slowly becomes less sensitive to PTSD. This works only on some patients. The investigators propose to expose PTSD patients to a number of "training" sessions in which they will be in a virtual world (similar to a video game) driving a car through a place resembling Iraq. This will happen inside an MRI machine, and the investigators will obtain brain images while the patient is exploring the "virtual Iraq" environment. The investigators will project on the screen a bar that will let the patient know, in real time, which is the state of her or his brain, from CALM to STRESS. The job of the patient will be to try to come up with personal strategies (breathe slowly, think calming thoughts) to try to bring the bar to CALM. The investigators believe that after a number of sessions, the patient will be able to create personalized mental strategies to bring their brain to CALM state, even in real life. This could become a much stronger way of performing "exposure therapy". Finally, the investigators will use a wearable device (similar to a wristwatch) to be able to study physical activity and sleep patters in PTSD patients through the training, in the hope that the investigators may find a way to objectively study when a patient is doing better.
Status | Terminated |
Enrollment | 8 |
Est. completion date | November 24, 2020 |
Est. primary completion date | August 14, 2020 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 64 Years |
Eligibility | Inclusion Criteria: - Meet CAPS5 PTSD criteria - OEF/OIF/OND & PGW Veterans - Seeking treatment for PTSD Exclusion Criteria: - DSM-5 criteria for drug or alcohol abuse or dependence in past 30 days - History of moderate to severe traumatic brain injury - Presence of contraindications to MRI - Current neurological or general medical conditions known to impact cognitive and/or emotional functioning (epilepsy, Parkinson's, etc.) - Acute psychological instability, schizophrenia, etc. |
Country | Name | City | State |
---|---|---|---|
United States | Michael E. DeBakey VA Medical Center, Houston, TX | Houston | Texas |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development | Baylor College of Medicine |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | CAPS5 PTSD criteria | Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
The CAPS is the gold standard in PTSD assessment. The CAPS-5 is a 30-item structured interview that can be used to: Make current (past month) diagnosis of PTSD Make lifetime diagnosis of PTSD Assess PTSD symptoms over the past week In addition to assessing the 20 DSM-5 PTSD symptoms, questions target the onset and duration of symptoms, subjective distress, impact of symptoms on social and occupational functioning, improvement in symptoms since a previous CAPS administration, overall response validity, overall PTSD severity, and specifications for the dissociative subtype (depersonalization and derealization). The CAPS was designed to be administered by clinicians and clinical researchers who have a working knowledge of PTSD, but can also be administered by appropriately trained paraprofessionals. The full interview takes 45-60 minutes to administer. |
Change from baseline at 6 weeks | |
Secondary | Wearable device data: heart rate | The investigators will collect heart rate data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Heart rate will be measured over time in beats per minute. | Change from baseline at 6 weeks | |
Secondary | Wearable device data: sleep patterns | The investigators will collect sleep pattern data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Sleep patterns will be measured over time in number of wake events per night. | Change from baseline at 6 weeks | |
Secondary | Wearable device data: total sleep | The investigators will collect total sleep data from wearable devices. It will be used to study any possible correlations between wearable device results and changes in CAPS5 during the training, regardless of whether the changes in CAPS5 are due to the training or not. Total sleep will be measured over time in minutes of sleep per day. | Change from baseline at 6 weeks |
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