Clinical trial NCT04302181: Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD
Official title: Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat Posttraumatic Stress Disorder (PTSD) in Active Duty or Retired Service Members: A Pilot Study
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Stress Disorders, Post-Traumatic
Lead sponsor: The University of Texas Health Science Center at San Antonio
Sponsor class: OTHER
Collaborators: name: United States Department of Defense
First posted: 2020-03-10
Enrollment: 12
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A small open-label treatment study
Primary purpose: TREATMENT

Brief summary: This is a small, open-label treatment study that tests the potential safety and treatment effectiveness of a stellate ganglion block combined with Massed Prolonged Exposure (PE). Each of the 12 participants will receive ten 90-minute sessions of Massed Prolonged Exposure and an injection of a stellate ganglion block between the first and second PE sessions.

Detailed description: Massed PE will be conducted by 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. The stellate ganglion block injection 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.

During PE treatment, participants will complete interim assessments of their PTSD symptoms, mood symptoms, trauma-related cognitions, and suicidal ideation proceeding sessions 6 and 10.

Eligibility criteria: Inclusion Criteria:

1. Active duty or retired military service member (age 18- 65 years)
2. PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
3. Able to speak and read English (due to standardization of outcome measures)
4. Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block.

Exclusion Criteria:

1. Classification as high risk for suicide
2. Current serious mental health diagnosis (e.g., bipolar or psychosis)
3. Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
4. Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding
5. Current anticoagulant use
6. History of bleeding disorder
7. Infection or mass at injection site
8. Myocardial infarction within 6 months of procedure
9. Pathologic bradycardia or irregularities of heart rate or rhythm;
10. Symptomatic hypotension
11. Phrenic or laryngeal nerve palsy
12. History of glaucoma
13. Uncontrolled seizure disorder
14. History of allergy to local anesthetics

Primary outcomes:
measure: Change in CAPS-5 (Clinician-Administered PTSD Scale)
timeFrame: Baseline, 1 month and 3 months
measure: Change in PCL-5 (Posttraumatic Stress Disorder Checklist)
timeFrame: Baseline, 1 month and 3 months
Secondary outcomes:
measure: Change in PHQ-9 (Patient Health Questionnaire-9)
timeFrame: Baseline, 1 month and 3 months
measure: Change in Brief Inventory of Psychosocial Functioning
timeFrame: Baseline, 1 month and 3 months
measure: Change in GAD-7 (General Anxiety Disorder Screener)
timeFrame: Baseline, 1 month and 3 months
measure: Change in PTCI (Posttraumatic Cognitions Inventory)
timeFrame: Baseline, 1 month and 3 months
Other outcomes:
Locations:
city: Fort Sam Houston
country: United States
facility: Brooke Army Medical Center
state: Texas
city: San Antonio
country: United States
facility: University of Texas Health Science Center at San Antonio
state: Texas
Study officials:
affiliation: University of Texas Health San Antonio Texas at San Antonio
name: Alan Peterson, PhD, ABPP
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: Gunduz OH, Kenis-Coskun O. Ganglion blocks as a treatment of pain: current perspectives. J Pain Res. 2017 Dec 14;10:2815-2826. doi: 10.2147/JPR.S134775. eCollection 2017.
citation: 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.
citation: 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.
citation: 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.