Mindfulness combined with interoceptive training for anxiety sensitivity
Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement
NA · Veterans Medical Research Foundation · NCT06786572
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
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 48 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Veterans Medical Research Foundation (other) |
| Locations | 1 site (San Diego, California) |
| Trial ID | NCT06786572 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
San Diego, California
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Anxiety Sensitivity, anxiety sensitivity, mindfulness, interoception