Effectiveness and Acceptability of Stellate Ganglion Block for Posttraumatic Stress Disorder Symptoms - Acceptability

NCT03302312 | Completed

• 1 other identifier: SGB-201a
• Study Type: observational
• Target: 54
• Locations: 2 countries
• Sites: 3

Brief Summary

This qualitative study will use focus groups, small group interviews, and individual interviews (both in person and over the phone) to compile a range of perspectives on service members' decision-making processes and information needs related to Stellate Ganglion Block (SGB). Participants will include service members, spouses, and providers.

Conditions

Posttraumatic Stress Disorder

Keywords

Posttraumatic Stress Disorder; Generalized Anxiety Disorder; Depression; Distress; Alcohol Use; Pain

Outcome Measures

Primary Outcomes (2)

• Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of service members or service member/spouse couples.

  Discussion topic areas: * Context for mental health and treatment * Advantages and drawbacks of treatment options * Information and decision-making * Experience and expectations

  Within three month of receiving one SGB study procedure for PTSD symptoms

• Participants' perceptions of SGB in relation to other options for treatment of PTSD, from the perspectives of providers

  Discussion topic areas: * Context for mental health and treatment * Advantages and drawbacks of treatment options * Information and decision-making * Experience and expectations

  Through study completion, approximately six months

Study Arms (2)

Participants

Service members who received at least one SGB study procedure as part of the clinical effectiveness trial during the three months prior to qualitative data collection or service members who received at least one SGB for PTSD symptoms at a study site in the three months prior to qualitative data collection.

Providers

Behavioral Health or other (e.g., Family Medicine) clinicians who have referred or could potentially have referred service members for SGB for PTSD symptoms, as well as physicians who provide SGBs.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

* participants in effectiveness clinical trial and their spouses * service members who have received SGB for PTSD symptoms at the participating study sites outside of the clinical trial and their spouse * providers who have referred or could potentially have referred patients for SGB for PTSD symptoms at the study sites * clinicians who provide SGB for PTSD

You may qualify if:

• Service members must have received at least one SGB and/or study procedure for PTSD symptoms during the past three months at a participating study site (as a participant in the clinical effectiveness trial or outside of the study).
• Clinical trial participants must have indicated willingness to participate in the qualitative study when asked by the Research Coordinator (RC) at baseline data collection.
• Non-clinical trial participants must be active-duty status.
• A service member/spouse dyad will consist of a service member meeting an above criterion and his/her spouse.
• Providers will be Behavioral Health or other (e.g., Family Medicine) clinicians who have referred or could potentially have referred service members to the study, and physicians who administer SGBs.

You may not qualify if:

• Service members will be excluded from the qualitative study if participation would cause them undue distress, in the opinion of the RC or treating clinician.

Sponsors & Collaborators

• RTI International: lead
• Womack Army Medical Center: collaborator
• Tripler Army Medical Center: collaborator
• Landstuhl Regional Medical Center: collaborator

Study Sites (3)

Tripler Army Medical Center (TAMC)

Honolulu, Hawaii, 96859, United States

Location

Womack Army Medical Center (WAMC)

Fort Bragg, North Carolina, 28310, United States

Location

Landstuhl Regional Medical Center (LRMC)

Landstuhl, 66849, Germany

Location

Related Publications (1)

• Krueger, R.A., & M.A. Casey, M. A. (2000). Focus groups. A practical guide for applied research. Thousand Oaks, CA: Sage.

  BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Generalized Anxiety Disorder; Depression; Alcohol Drinking; Pain

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Anxiety Disorders; Behavioral Symptoms; Behavior; Drinking Behavior; Neurologic Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Bradford B Walters, MD, PhD, MBA

  RTI International

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 28, 2017
• First Posted: October 5, 2017
• Study Start: November 3, 2017
• Primary Completion: March 2, 2018
• Study Completion: March 2, 2018
• Last Updated: July 30, 2018

Record last verified: 2018-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); DE (1)