post traumatic stress disorder
Conditions
Interventions
Group 1: Treatment scheme A (15 training sessions + 2 booster treatments
Group 2: Treatment scheme (8 training sessions)
Sponsors
GrayMatters Health Ltd.
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Ages 18 to 65 2. Any gender 3. Diagnosis of PTSD as the primary psychiatric diagnosis by the study psychiatrist via clinical interview and CAPS-5 with a minimum CAPS-5 severity score of 30 4. 1 year to 25 years since index trauma 5. Ability to give signed, informed consent 6. Normal or corrected-to-normal vision 7. Normal or corrected to normal hearing 8. Subject is able to adhere to the study schedule
Exclusion criteria
Exclusion criteria: 1. Have completed two or more full courses of trauma-focused therapy in the past (i.e., EMDR, Prolong Exposure Therapy etc.), eligibility will be deemed upon the clinical judgement of the investigator. 2. Lifetime diagnosis for schizophrenia, schizoaffective disorder, schizophreniform disorder, Bipolar I disorder, or delusional disorder 3. Any mood disorder and anxiety disorder according to DSM-5 (in addition to those described in Exclusion 2) that is the primary focus of treatment in the last 6 months prior to screening, as per the clinical judgement of the investigator 4. Lifetime diagnosis of autism, mental retardation at discretion of investigator. 5. Diagnosis of moderate or severe substance use disorder within the last 3 months of screening visit (as defined in DSM-5- substance use disorder) or at screening visit 6. Any prescribed Benzodiazepine which cannot be ceased for the duration of the study (with a washout period of at least 2 weeks prior to the first Prism training session) or which cannot be replaced with short-acting benzodiazepines that are taken only for sleeping during the night 7. Any psychotropic medication other than a stable dose of selective serotonin reuptake inhibitors (SSRIs) or serotoninnorepinephrine reuptake inhibitor (SNRIs) 8. Any change in- or initiation of- SSRIs or SNRIs antidepressants within the past 4 weeks. At the time of recruitment, patients must have no intention of changing their medication or psychotherapy during the study duration 9. Any suicidal behavior in the past 1 year (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior) prior to screening and during the screening period 10. Recent initiation (within the past 3 months) of cognitivebehavioral therapy or any evidence-based PTSD psychotherapy (Cognitive Processing Therapy [CPT], Prolonged Exposure [PE], Eye Movement Desensitization and Reprocessing [EMDR]); continuation of established maintenance supportive therapy will be permitted 11. Any history of brain surgery, of penetrating, neurovascular, infectious, or other major brain injury, of epilepsy, or of other major neurological abnormality (including a history of traumatic brain injury [TBI] with loss of consciousness for more than 24 hours or posttraumatic amnesia for more than 7 days) 12. History of Stroke 13. Any unstable medical condition, as per the clinical judgement of the investigator 14. In process of establishing/changing governmental/institutional compensation payments for PTSD symptoms 15. Enrollment in another clinical study at screening or within 2 months prior to screening, or intended enrollment within the duration of this study 16. Women who are pregnant, nursing, or who plan to become pregnant while in the trial 17. Contraindications to MRI (e.g., metal in body, claustrophobia)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary objective of this study is to investigate the efficacy of the Prism treatment with regards to the reduction of post-traumatic stress disorder (PTSD) clinical symptoms for the two dosing regimens. | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess the portion of subjects who demonstrate clinically meaningful improvement in the Clinician Administered PTSD Scale (CAPS – 5) score from Baseline to the 3 months follow-up visit. Clinically meaningful improvement is defined here as a 6-point reduction or more in the CAPS-5 score. | — |
Countries
Germany, Israel
Contacts
Public ContactChristian Paret-Voigt
ZI Mannheim
Outcome results
None listed