An interventional study of Mindfulness training and Interoceptive exposure in Anxiety Sensitivity, sponsored by Veterans Medical Research Foundation. Recruiting at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-02-02.
Sponsored by Veterans Medical Research Foundation · Not applicable, Interventional, and Other
This pilot randomized controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an intervention for anxiety sensitivity.
Anxiety sensitivity (AS), which involves fear that arousal related symptoms will have negative physical, social or psychological ramifications, is an important driver of anxiety, trauma-related and somatic disorders. Cognitive behavioral therapy (CBT), particularly involving interoceptive exposure (IE; i.e., exposure to unwanted internal sensations), has the greatest demonstrated efficacy at reducing AS but can be hard to tolerate. Conversely, mindfulness is sought out for management of multiple mental health problems, but the observed clinical effects are often modest. A hybrid of these two approaches may capitalize on the strengths of each approach. Mindfulness training (MT) may increase the tolerability of exposure, enhance compliance and support extinction learning through increased engagement with the feared stimulus and heightened awareness of the nonoccurrence of feared outcomes. This project will evaluate the feasibility and acceptability of a novel hybrid intervention, Interoceptive Training Enhanced Mindfulness (ITEM), which combines IE with MT, evaluate its feasibility and acceptability. Forty-eight Veterans will be randomized to receive ITEM or IE in six one-on-one sessions delivered via telehealth. They will complete assessments before and after the 6-week intervention period. Outcomes related to engagement and compliance with ITEM and IE will be the primary focus. Because multiple mental health (e.g., anxiety, posttraumatic stress disorder, eating disorders and depression) and physical health (e.g., chronic pain, conditions related to toxic exposure) problems are driven by maladaptive reactions to interoceptive cues, this intervention has the potential to ultimately produce wide-spread mental and physical health benefits.
Veterans Medical Research Foundation is the lead sponsor of 43 studies on the registry; 9 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Brief mindfulness training focused on management of unwanted internal sensations
Other: Mindfulness training
Cognitive behavioral intervention featuring systematic exposure to unwanted internal sensations
Behavioral: Interoceptive exposure
Brief mindfulness training focused on management of unwanted internal sensations
Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations
Enrollment rate
Number enrolled out of number approached
Time frame: Typically up to 3 months, from initial referral to decision to enroll or not
Attendance
Average number of sessions attended
Time frame: During the six-week intervention period
Clinician's judgment of proportion of completion of at home assignments
Clinician's judgment of proportion of completion of at home assignments on a scale including none, partial and complete
Time frame: During the six-week intervention period
Client Satisfaction Questionnaire-4 (CSQ-4)
The CSQ-4 is a validated measure of participant satisfaction with care delivered with higher scores (range 4-16) indicating greater satisfaction.
Time frame: Week 6, following the final treatment session
Reliable change
Proportion improved, unchanged and worsened based on the Reliable Change Index using the Overall Anxiety Symptoms and Impairment Scale (OASIS).
Time frame: Over a 6-8 week period from baseline to post-treatment
Plan to share: Yes — Final datasets in machine-readable format will be shared via PubMed Central
Supporting information: Study protocol, Sap, Icf
No publications or documents are linked to this record.
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Veterans Medical Research Foundation