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Interoceptive Exposure for Anxiety
N/A
Waitlist Available
Research Sponsored by G.V. (Sonny) Montgomery VA Medical Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Must not have
Veterans who are currently receiving (or who are scheduled to begin) individual exposure-based treatment for PTSD will be excluded from the study.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether Interoceptive Exposure (IE) can help reduce negative thoughts and arousal in veterans with PTSD during an anxiety-inducing situation.
Who is the study for?
This trial is for OEF/OIF veterans with combat-related PTSD, probable PTSD diagnosis (PTSD Checklist score >44), high anxiety sensitivity (ASI score >28), and medical clearance. Excluded are those with conditions affecting study participation or data integrity, such as uncontrolled blood pressure, severe asthma, dementia, psychotic disorders, acute mania, current substance abuse or certain medications.
What is being tested?
The trial tests Interoceptive Exposure (IE) to reduce negative thoughts and arousal in anxious situations among veterans with PTSD. Participants undergo IE or supportive counseling over four weeks at GVSMVAMC and are assessed before and after treatment using interviews, self-reports, and a social stressor task.
What are the potential side effects?
While the specific side effects of Interoceptive Exposure aren't detailed here since it's a psychological intervention rather than a drug therapy; participants may experience increased anxiety or discomfort when exposed to the sensations of arousal during sessions.
Eligibility Criteria
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I am not currently undergoing or scheduled for individual PTSD treatment.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: IEExperimental Treatment1 Intervention
Participants will complete an at home four-week, intervention targeting their negative cognitions triggered by physical sensations. The goal of IE is to purposefully induce bodily sensations related to autonomic arousal so that participants can learn that those sensations are not harmful. IE and Cognitive restructuring have been found to be superior to progressive muscle relaxation as a way to avoid aversive autonomic sensations.
Group II: 2Active Control1 Intervention
waitlist control
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Who is running the clinical trial?
G.V. (Sonny) Montgomery VA Medical CenterLead Sponsor
2 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My previous treatments or refusals won't exclude me from this study.I am not currently undergoing or scheduled for individual PTSD treatment.
Research Study Groups:
This trial has the following groups:- Group 1: IE
- Group 2: 2
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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