Mindfulness combined with interoceptive training for anxiety sensitivity
Official title: Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement
Run by Veterans Medical Research Foundation · NCT06786572 · Data updated 2026-11-12
This trial will test whether adding interoceptive training to mindfulness helps Veterans with high anxiety sensitivity tolerate treatment better and engage more with therapy.
Quick facts
| Study type | Interventional |
|---|---|
| Ages | 18 Years and up |
| Sex | All |
| Enrollment | 48 (estimated) |
| Sponsor | Veterans Medical Research Foundation Academic / other |
| Locations | 1 site (San Diego, California) |
| Status | Recruiting |
| Started | September 10, 2025 |
| Main results expected | March 31, 2027 |
| Study ends | March 31, 2027 |
| Registry record updated | February 2, 2026 |
| Trial ID | NCT06786572 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are Veterans who can read and speak English, have an ASI-3 score of 23 or higher, clinically meaningful distress (CGI ≥ 3), internet access for telehealth, and ability to attend any required in-person visits.
✕Probably not a fit
Patients with serious mental illness (bipolar or psychotic disorders), current untreated alcohol or substance use disorders, moderate-severe imminent suicidality, regular current meditation practice, ongoing treatment for an AS-related condition, or cognitive deficits that impair participation are unlikely to benefit or are excluded.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This pilot randomized controlled study will compare a novel hybrid intervention called Interoceptive Training Enhanced Mindfulness (ITEM) with standard interoceptive exposure (IE) in Veterans who have elevated anxiety sensitivity. Forty-eight Veterans will be randomized to receive six one-on-one sessions of ITEM or IE delivered via telehealth, with assessments before and after the six-week intervention period. The primary focus is on feasibility and acceptability, including measures of engagement and compliance, while symptom and functional measures will be collected as secondary outcomes. ITEM combines mindfulness practices with targeted interoceptive exposure to increase tolerability and support learning that feared internal sensations are safe.
Why it matters
Potential benefit: If successful, the hybrid approach could make exposure-based treatment easier to tolerate and improve symptoms and engagement in Veterans with anxiety sensitivity.
How similar studies have gone: Interoceptive exposure within CBT has strong evidence for reducing anxiety sensitivity and mindfulness alone shows modest effects, but combining the two is a novel approach with limited prior testing.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * Veteran status * able to read and speak English * ASI-3 score of 23 or higher * clinically meaningful distress/impairment related to an emotional or somatic complaint as determined by a Clinical Global Impression Scale (CGI) of 3 or greater * Internet access via a device that can support remote study activities and ability to attend in person appointments Exclusion Criteria: * serious mental illness, including bipolar disorder or psychotic illness * current, untreated alcohol or substance use disorder * moderate-severe suicidality that would likely result in the need for urgent intervention in the next 2 months * current regular meditation practice or treatment for AS-related condition * cognitive dysfunction that interferes with the ability to engage in treatment
Where it's running
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VA San Diego Healthcare System
San Diego, California, United States Recruiting
Study contacts
- Study coordinator: Ariel J Lang, PhD, MPH
- Email: ariel.lang@va.gov
- Phone: 8585528585
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How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.