VA San Diego Healthcare System
San Diego, California, 92161, United States
Location status: Recruiting
NCT Number: NCT06786572
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.
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Not applicable
San Diego, California, 92161, United States
Location status: Recruiting
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.
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Brief mindfulness training focused on management of unwanted internal sensations
Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations
Time frame: Typically up to 3 months, from initial referral to decision to enroll or not
Number enrolled out of number approached
Time frame: During the six-week intervention period
Average number of sessions attended
Time frame: During the six-week intervention period
Clinician's judgment of proportion of completion of at home assignments on a scale including none, partial and complete
Time frame: Week 6, following the final treatment session
The CSQ-4 is a validated measure of participant satisfaction with care delivered with higher scores (range 4-16) indicating greater satisfaction.
Time frame: Over a 6-8 week period from baseline to post-treatment
Proportion improved, unchanged and worsened based on the Reliable Change Index using the Overall Anxiety Symptoms and Impairment Scale (OASIS).
Contact information is provided by the study sponsor or research team.
Veterans Medical Research Foundation
Other
Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement
Acronym: ITEM
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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