Back to resultsAugmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD
Primary Purpose
Stress Disorders, Post-Traumatic
Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
Ropivacaine injection
Sponsored by
About this trial
This is an interventional treatment trial for Stress Disorders, Post-Traumatic
Eligibility Criteria
Inclusion Criteria:
- Active duty or retired military service member (age 18- 65 years)
- PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
- Able to speak and read English (due to standardization of outcome measures)
- Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block.
Exclusion Criteria:
- Classification as high risk for suicide
- Current serious mental health diagnosis (e.g., bipolar or psychosis)
- Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
- Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding
- Current anticoagulant use
- History of bleeding disorder
- Infection or mass at injection site
- Myocardial infarction within 6 months of procedure
- Pathologic bradycardia or irregularities of heart rate or rhythm;
- Symptomatic hypotension
- Phrenic or laryngeal nerve palsy
- History of glaucoma
- Uncontrolled seizure disorder
- History of allergy to local anesthetics
Sites / Locations
- Brooke Army Medical Center
- University of Texas Health Science Center at San Antonio
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Stellate Ganglion Block
Arm Description
One time administration of a stellate ganglion block
Outcomes
Primary Outcome Measures
Change in CAPS-5 (Clinician-Administered PTSD Scale)
A 30-item structured interview used to assess symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning.
Change in PCL-5 (Posttraumatic Stress Disorder Checklist)
A 20-item self-report measure that assesses the presence and severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5).
Secondary Outcome Measures
Change in PHQ-9 (Patient Health Questionnaire-9)
A 9-item self-report measure that assesses the presence and severity of depressive symptoms.
Change in Brief Inventory of Psychosocial Functioning
A 7-item self-report measure assessing respondents' level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living.
Change in GAD-7 (General Anxiety Disorder Screener)
A 9-item self-report measure that assesses the presence and severity of general anxiety symptoms.
Change in PTCI (Posttraumatic Cognitions Inventory)
A 36-item self-report measure that assesses self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure.
Full Information
NCT ID
NCT04302181
First Posted
March 6, 2020
Last Updated
September 8, 2022
Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
United States Department of Defense
1. Study Identification
Unique Protocol Identification Number
NCT04302181
Brief Title
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
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Completed
Study Start Date
October 5, 2020 (Actual)
Primary Completion Date
July 1, 2021 (Actual)
Study Completion Date
December 3, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
The University of Texas Health Science Center at San Antonio
Collaborators
United States Department of Defense
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress Disorders, Post-Traumatic
7. Study Design
Primary Purpose
Treatment
Study Phase
Early Phase 1
Interventional Study Model
Single Group Assignment
Model Description
A small open-label treatment study
Masking
None (Open Label)
Masking Description
Masked clinical diagnostic assessor for the CAPS-5
Allocation
N/A
Enrollment
12 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Stellate Ganglion Block
Arm Type
Experimental
Arm Description
One time administration of a stellate ganglion block
Intervention Type
Drug
Intervention Name(s)
Ropivacaine injection
Other Intervention Name(s)
Naropin
Intervention Description
6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion
Primary Outcome Measure Information:
Title
Change in CAPS-5 (Clinician-Administered PTSD Scale)
Description
A 30-item structured interview used to assess symptoms of PTSD. Questions target the onset and duration of symptoms, subjective distress, impact on social and occupational functioning.
Time Frame
Baseline, 1 month and 3 months
Title
Change in PCL-5 (Posttraumatic Stress Disorder Checklist)
Description
A 20-item self-report measure that assesses the presence and severity of PTSD symptoms using the Diagnostic and Statistical Manual of mental disorders (DSM-5).
Time Frame
Baseline, 1 month and 3 months
Secondary Outcome Measure Information:
Title
Change in PHQ-9 (Patient Health Questionnaire-9)
Description
A 9-item self-report measure that assesses the presence and severity of depressive symptoms.
Time Frame
Baseline, 1 month and 3 months
Title
Change in Brief Inventory of Psychosocial Functioning
Description
A 7-item self-report measure assessing respondents' level of functioning in seven life domains: romantic relationship, relationship with children, family relationships, friendships and socializing, work, training and education, and activities of daily living.
Time Frame
Baseline, 1 month and 3 months
Title
Change in GAD-7 (General Anxiety Disorder Screener)
Description
A 9-item self-report measure that assesses the presence and severity of general anxiety symptoms.
Time Frame
Baseline, 1 month and 3 months
Title
Change in PTCI (Posttraumatic Cognitions Inventory)
Description
A 36-item self-report measure that assesses self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure.
Time Frame
Baseline, 1 month and 3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Active duty or retired military service member (age 18- 65 years)
PTSD diagnosis as assessed by Clinician-Administered Posttraumatic Stress Scale (CAPS-5)
Able to speak and read English (due to standardization of outcome measures)
Defense Enrollment Eligibility Reporting System (DEERS)-eligible to receive care at Brooke Army Medical Center for the stellate ganglion block.
Exclusion Criteria:
Classification as high risk for suicide
Current serious mental health diagnosis (e.g., bipolar or psychosis)
Symptoms of moderate to severe substance (to include alcohol) use within the last 30 days
Pregnancy (i.e. positive pregnancy test at screening) or breastfeeding
Current anticoagulant use
History of bleeding disorder
Infection or mass at injection site
Myocardial infarction within 6 months of procedure
Pathologic bradycardia or irregularities of heart rate or rhythm;
Symptomatic hypotension
Phrenic or laryngeal nerve palsy
History of glaucoma
Uncontrolled seizure disorder
History of allergy to local anesthetics
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Alan Peterson, PhD, ABPP
Organizational Affiliation
University of Texas Health San Antonio Texas at San Antonio
Official's Role
Principal Investigator
Facility Information:
Facility Name
Brooke Army Medical Center
City
Fort Sam Houston
State/Province
Texas
ZIP/Postal Code
78234
Country
United States
Facility Name
University of Texas Health Science Center at San Antonio
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78229
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
29362795
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. Erratum In: JAMA. 2018 Aug 21;320(7):724.
Results Reference
background
PubMed Identifier
27187898
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.
Results Reference
background
PubMed Identifier
29276402
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.
Results Reference
background
PubMed Identifier
19034755
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.
Results Reference
background
PubMed Identifier
27612365
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.
Results Reference
background
PubMed Identifier
25269132
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.
Results Reference
background
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Augmenting Massed Prolonged Exposure With a Stellate Ganglion Block to Treat PTSD
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