Targeted Plasticity Therapy for Posttraumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT04064762|
Recruitment Status : Not yet recruiting
First Posted : August 22, 2019
Last Update Posted : September 17, 2019
|Condition or disease||Intervention/treatment||Phase|
|Post Traumatic Stress Disorder||Device: Paired Vagus Nerve Stimulation||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Targeted Plasticity Therapy for Posttraumatic Stress Disorder|
|Estimated Study Start Date :||March 2020|
|Estimated Primary Completion Date :||January 2021|
|Estimated Study Completion Date :||March 2023|
Experimental: Vagus Nerve Stimulation + Prolonged Exposure Therapy
Study treatment is vagus nerve stimulation (VNS) delivered during Prolonged Exposure Therapy.
Device: Paired Vagus Nerve Stimulation
Stimulation of the vagus nerve that is paired with Prolonged Exposure Therapy.
- Incidence of Serious Device Related Adverse Events [Device Feasibility] [ Time Frame: Week 35 (Six months post VNS+PE therapy intervention) ]Device will be considered safe if 25% or fewer participants experience a serious device related adverse event that requires the explant of the device.
- Demographic Data [ Time Frame: Week 1 ]Participant demographic variables will be obtained through a standard self-report form or the patient's medical record at baseline and will include age, race, ethnicity, marital status, education level, employment, income, insurance status, veteran status, premorbid psychiatric history, and history of substance use.
- PTSD Symptom Scale for DSM-5 (PSSI-5) [ Time Frame: Week 1, 5, 11, 15, 23 ,35 ]The PSSI-5 is a 24-item, psychometrically validated, semi-structured interview that assesses PTSD symptoms in the past two weeks, and makes a diagnostic determination based on the DSM-5 criteria (Foa et al., 2016b). The PSSI-5 screens for the presence of a Criterion A traumatic event, the "index trauma," which functions as the focus of the interview, meaning that all other items refer to that event. Questions assess for PTSD symptoms corresponding to the 4 DSM-5 clusters of re-experiencing, avoidance, changes in mood and cognition, and arousal and hyperactivity, in addition to interference, distress, and duration of symptoms. The interviewer rates participant responses to symptom questions on a 5-point scale of frequency and severity, from 0 ("Not at all") to 4 ("6 or more times a week/severe").
- MINI International Neuropsychiatric Interview (MINI) [ Time Frame: Week 5, 11, 15, 23, 35 ]The MINI is a structured clinical interview that has been effectively validated using the Structured Clinical Interview for DSM-III-R (SCID) and the Composite International Diagnostic Interview with good concordance (Hergueta et al., 1998). It assesses multiple diagnoses including Posttraumatic Stress Disorder, Major Depressive Depression, and Generalized Anxiety Disorder.
- Posttraumatic Diagnostic Scale for DSM-5 (PDS-5) [ Time Frame: Week 5-11, 15, 23, 35 ]The PDS-5 is a 20-item psychometrically validated measure designed to confirm a diagnosis of PTSD and measure the severity of PTSD symptoms (Foa et al., 2016a). Severity is measured on a scale from 0 to 51. The measure is based on the DSM-5 diagnostic criteria for PTSD.
- Patient Health Questionnaire-9 (PHQ-9) [ Time Frame: Week 5-11, 15, 23, 35 ]The PHQ-9 is a brief self-report measure of major depressive disorder (Kroenke et al, 2001). The PHQ-9 is considered to be a valid measure of depression for population-based studies and clinical populations (Corson, Gerrity, & Dobscha, 2004) with a cut off score of equal or greater than 10 as the diagnostic for current depression.
- Posttraumatic Cognitions Inventory (PTCI) [ Time Frame: Week 5-11, 15, 23, 35 ]The PTCI is a 36-item instrument that assesses dysfunctional post-trauma cognitions across self, world, and self-blame to yield a total score (Foa et al., 1999). The scale has high internal consistencies (.97, .88, .86, .97, respectively) and correlates well with PTSD severity, anxiety, and depression (.44 to .79).
- Generalized Anxiety Disorder 7-item Scale (GAD-7) [ Time Frame: Week 5, 11, 15, 23, 35 ]The GAD7 is a 7-item questionnaire that measures severity of anxiety (Spitzer et al, 2006). Response options are "not at all," "several days," "more than half the days," and "nearly every day," scored as 0, 1, 2, and 3, respectively. Therefore, GAD-7 scores range from 0 to 21, with scores of 5, 10, and 15 representing mild, moderate, and severe anxiety symptom levels, respectively.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04064762
|Contact: Mark Powers, PhDfirstname.lastname@example.org|
|Contact: Emma Turner, BAemail@example.com|
|United States, Texas|
|Baylor University Medical Center||Not yet recruiting|
|Dallas, Texas, United States, 75246|
|Contact: Mark Powers, PhD firstname.lastname@example.org|
|Contact: Emma Turner, BA email@example.com|
|Principal Investigator: Michael Foreman, MD|
|Sub-Investigator: Mark Powers, PhD|
|Principal Investigator:||Michael Kilgard, PhD||University of Texas at Dallas|
|Principal Investigator:||Robert Rennaker, PhD||University of Texas at Dallas|
|Study Director:||Seth Hays, PhD||University of Texas at Dallas|
|Principal Investigator:||Jane Wigginton, MD||University of Texas Southwestern Medical Center|
|Principal Investigator:||Michael Foreman, MD FACS||Baylor Health Care System|
|Study Director:||Richard Naftalis, MD FAANS FACS||Baylor Health Care System|
|Study Director:||Mark Powers, PhD||Baylor Health Care System|
|Study Director:||Ann Marie Warren, PhD||Baylor Health Care System|