Stress Disorders, Post-Traumatic
Conditions
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.
Interventions
DRUGRopivacaine injection
6.5cc of Ropivacaine HCl 0.5%, one time into the stellate ganglion
Sponsors
United States Department of Defense
The University of Texas Health Science Center at San Antonio
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Masking description
Masked clinical diagnostic assessor for the CAPS-5
Intervention model description
A small open-label treatment study
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in CAPS-5 (Clinician-Administered PTSD Scale) | Baseline, 1 month and 3 months | 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) | Baseline, 1 month and 3 months | 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
| Measure | Time frame | Description |
|---|---|---|
| Change in Brief Inventory of Psychosocial Functioning | Baseline, 1 month and 3 months | 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) | Baseline, 1 month and 3 months | A 9-item self-report measure that assesses the presence and severity of general anxiety symptoms. |
| Change in PTCI (Posttraumatic Cognitions Inventory) | Baseline, 1 month and 3 months | A 36-item self-report measure that assesses self-blame, negative cognitions about self, and negative cognitions about the world following trauma exposure. |
| Change in PHQ-9 (Patient Health Questionnaire-9) | Baseline, 1 month and 3 months | A 9-item self-report measure that assesses the presence and severity of depressive symptoms. |
Countries
United States
Outcome results
None listed