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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The goal of this clinical trial is to compare the combination of Massed Prolonged Exposure (PE); a behavioral therapy for PTSD) and a stellate ganglion block (SGB; an injection of a local anesthetic into the front of the neck) with Massed Prolonged Exposure and a sham injection in a sample of military service members or retirees with PTSD. The main questions it aims to answer are: (1) Does the addition of an SGB improve treatment outcomes associated with Massed PE and (2) Do differences in psychophysiological arousal during the exposure portion of treatment help explain treatment outcomes for PTSD. Participants will receive ten 90-minute session of Massed PE. Between the first and second Massed PE sessions, half of the participants will receive a SGB, and half will receive a sham SGB.
Massed PE will be conducted by master-level or doctoral-level therapists. Participants will meet with their providers for individual, 90-minute sessions. They will then be asked to complete out-of-session treatment assignments throughout the rest of the day. Between the individual therapy session and out-of-session treatment assignments, participants will engage in approximately four to six hours of treatment per day, Monday through Friday, for two weeks. Each participant will also be offered three booster sessions at 1-, 3-, and 7-weeks posttreatment.
The stellate ganglion block injection or the sham SGB will be administered between the first and second massed PE session by qualified medical personnel as per standard operating procedure for the placement of a stellate ganglion block. A research nurse will be in attendance during the procedure and for an hour recovery period following the block administration.
Assessments will be administered at pretreatment, during treatment, at posttreatment, and at 1-, 3-, and 6-months following the completion of PE. The primary outcome assessment will be 1-month following the completion of PE. Following this assessment, participants randomized to the sham SGB arm of the study will be offered an SGB with ropivacaine.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Stellate Ganglion Block | Experimental | One time administration of a stellate ganglion block |
|
| Sham SGB | Placebo Comparator | One time administration |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Ropivacaine injection | Drug | 6.5cc of Ropivacaine hydrochloride (HCl) 0.5%, one time into the stellate ganglion |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change from baseline in Clinician-Administered PTSD Scale-DSM 5 (CAPS-5) | A 30-item structured interview used to assess change symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning. Total severity scores range from 0 to 80 with higher score indicative of greater PTSD severity. The measure can also be used to confirm the presence of a PTSD diagnosis. | Baseline and at 1-month, 3-month, and 6-month follow-up assessments |
| Change from baseline in Posttraumatic Stress Disorder Checklist -DSM 5 (PCL-5) | A 20-item self-report measure that assesses the presence and change in severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5). Total severity scores range from 0 to 80 with higher score indictive of greater PTSD severity. | Baseline and at 1-month, 3-month, and 6-month follow-up assessments |
| Measure | Description | Time Frame |
|---|---|---|
| Patient Health Questionnaire-9 items (PHQ-9) | A 9-item self-report measure that assesses the presence and change in severity of depressive symptoms. Total scores range from 0 to 27 with higher scores reflective of greater severity. | Baseline and at 1-month, 3-month, and 6-month follow-up assessments |
| General Anxiety Disorder Screener - 7 Items (GAD-7) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amanda Flores | Contact | 210-562-6726 | floresa13@uthscsa.edu |
| Name | Affiliation | Role |
|---|---|---|
| Alan Peterson, PhD | The University of Texas Health Science Center at San Antonio | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Carl R. Darnall Army Medical Center | Recruiting | Fort Hood | Texas | 76544 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29362795 | Background | Foa EB, McLean CP, Zang Y, Rosenfield D, Yadin E, Yarvis JS, Mintz J, Young-McCaughan S, Borah EV, Dondanville KA, Fina BA, Hall-Clark BN, Lichner T, Litz BT, Roache J, Wright EC, Peterson AL; STRONG STAR Consortium. Effect of Prolonged Exposure Therapy Delivered Over 2 Weeks vs 8 Weeks vs Present-Centered Therapy on PTSD Symptom Severity in Military Personnel: A Randomized Clinical Trial. JAMA. 2018 Jan 23;319(4):354-364. doi: 10.1001/jama.2017.21242. | |
| 27187898 |
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| ID | Term |
|---|---|
| D013313 | Stress Disorders, Post-Traumatic |
| ID | Term |
|---|---|
| D040921 | Stress Disorders, Traumatic |
| D000068099 | Trauma and Stressor Related Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000077212 | Ropivacaine |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000813 | Anilides |
| D000577 | Amides |
| D009930 | Organic Chemicals |
| D000814 | Aniline Compounds |
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The clinical staff, research staff, and the participant will be blind to study condition until after the 1-month follow-up assessment. After which time, the blind will be broken, and participants in the control condition will be offered the SGB.
| Normal saline | Drug | 6.5cc of Normal Saline one time into the stellate ganglion. |
|
A 9-item self-report measure that assesses the presence and change in severity of general anxiety symptoms. Total scores range from 0 to 21 with higher scores reflective of greater severity. |
| Baseline and at 1-month, 3-month, and 6-month follow-up assessments |
| Posttraumatic Cognitions Inventory (PTCI) | A 36-item self-report measure that assesses change in self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure. Total scores range from 33 to 231 with higher scores reflective of more problematic cognitions. | Baseline and at 1-month, 3-month, and 6-month follow-up assessments |
| Psychophysiological arousal - Galvanic Skin Response | Change in Psychophysiological data collected from a smart watch measuring galvanic skin response | Two weeks |
| Psychophysiological arousal - Skin Temperature | Change in Psychophysiological data collected from a smart watch measuring skin temperature | Two weeks |
| Psychophysiological arousal - Heart Rate | Change in Psychophysiological data collected from a smart watch measuring heart rate | Two weeks |
| Psychophysiological arousal - Interbeat Interval | Change in Psychophysiological data collected from a smart watch measuring interbeat interval | Two weeks |
| Psychophysiological arousal - Three-Dimensional Accelerometer Movement | Change in Psychophysiological data collected from a smart watch measuring three-dimensional accelerometer movement | Two weeks |
| Psychophysiological arousal - Electrodermal Activity | Change in Psychophysiological data collected from a smart watch measuring electrodermal activity | Two weeks |
| Psychophysiological arousal - Photoplethysmography | Change in Psychophysiological data collected from a smart watch measuring photoplethysmography | Two weeks |
| University of Texas Health Science Center at San Antonio | Recruiting | San Antonio | Texas | 78229 | United States |
|
| Background |
| Hanling SR, Hickey A, Lesnik I, Hackworth RJ, Stedje-Larsen E, Drastal CA, McLay RN. Stellate Ganglion Block for the Treatment of Posttraumatic Stress Disorder: A Randomized, Double-Blind, Controlled Trial. Reg Anesth Pain Med. 2016 Jul-Aug;41(4):494-500. doi: 10.1097/AAP.0000000000000402. |
| 19034755 | Background | Lipov EG, Joshi JR, Lipov S, Sanders SE, Siroko MK. Cervical sympathetic blockade in a patient with post-traumatic stress disorder: a case report. Ann Clin Psychiatry. 2008 Oct-Dec;20(4):227-8. doi: 10.1080/10401230802435518. No abstract available. |
| 27612365 | Background | Lynch JH, Mulvaney SW, Kim EH, de Leeuw JB, Schroeder MJ, Kane SF. Effect of Stellate Ganglion Block on Specific Symptom Clusters for Treatment of Post-Traumatic Stress Disorder. Mil Med. 2016 Sep;181(9):1135-41. doi: 10.7205/MILMED-D-15-00518. |
| 25269132 | Background | Mulvaney SW, Lynch JH, Hickey MJ, Rahman-Rawlins T, Schroeder M, Kane S, Lipov E. Stellate ganglion block used to treat symptoms associated with combat-related post-traumatic stress disorder: a case series of 166 patients. Mil Med. 2014 Oct;179(10):1133-40. doi: 10.7205/MILMED-D-14-00151. |
| 33242072 | Background | Odosso RJ, Petta L. The Efficacy of the Stellate Ganglion Block as a Treatment Modality for Posttraumatic Stress Disorder Among Active Duty Combat Veterans: A Pilot Program Evaluation. Mil Med. 2021 Jul 1;186(7-8):e796-e803. doi: 10.1093/milmed/usaa246. |
| 36602803 | Background | Peterson AL, Blount TH, Foa EB, Brown LA, McLean CP, Mintz J, Schobitz RP, DeBeer BR, Mignogna J, Fina BA, Evans WR, Synett S, Hall-Clark BN, Rentz TO, Schrader C, Yarvis JS, Dondanville KA, Hansen H, Jacoby VM, Lara-Ruiz J, Straud CL, Hale WJ, Shah D, Koch LM, Gerwell KM, Young-McCaughan S, Litz BT, Meyer EC, Blankenship AE, Williamson DE, Roache JD, Javors MA, Sharrieff AM, Niles BL, Keane TM; Consortium to Alleviate PTSD. Massed vs Intensive Outpatient Prolonged Exposure for Combat-Related Posttraumatic Stress Disorder: A Randomized Clinical Trial. JAMA Netw Open. 2023 Jan 3;6(1):e2249422. doi: 10.1001/jamanetworkopen.2022.49422. |
| D000588 |
| Amines |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |