RecruitingNot Applicable

Interoceptive Training Enhanced Mindfulness

United States48 participantsStarted 2025-09-10

Plain-language summary

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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Enrollment rate

Timeframe: Typically up to 3 months, from initial referral to decision to enroll or not

Attendance

Timeframe: During the six-week intervention period

Clinician's judgment of proportion of completion of at home assignments

Timeframe: During the six-week intervention period

Client Satisfaction Questionnaire-4 (CSQ-4)

Timeframe: Week 6, following the final treatment session

Reliable change

Timeframe: Over a 6-8 week period from baseline to post-treatment

Trial details

NCT IDNCT06786572

SponsorVeterans Medical Research Foundation

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-03-31

Contact for this trial

Ariel J Lang, PhD, MPH

8585528585 ariel.lang@va.gov

View on ClinicalTrials.gov More Anxiety Sensitivity trials

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Enrollment rate

Timeframe: Typically up to 3 months, from initial referral to decision to enroll or not

Attendance

Timeframe: During the six-week intervention period

Clinician's judgment of proportion of completion of at home assignments

Timeframe: During the six-week intervention period

Client Satisfaction Questionnaire-4 (CSQ-4)

Timeframe: Week 6, following the final treatment session

Reliable change

Timeframe: Over a 6-8 week period from baseline to post-treatment