NCT06786572 · Veterans Medical Research Foundation
Interoceptive Training Enhanced Mindfulness
(ITEM)
What this study is about
This pilot randomly assigned controlled trial will compare a novel mindfulness training to interoceptive exposure to establish feasibility and acceptability as an intervention for anxiety sensitivity.
View original scientific description
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.
Interventions
OTHER
Mindfulness training
Brief mindfulness training focused on management of unwanted internal sensations
BEHAVIORAL
Interoceptive exposure
Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations
Primary outcome measures
Enrollment rate
Time frame: Typically up to 3 months, from initial referral to decision to enroll or not
Number enrolled out of number approached
Attendance
Time frame: During the six-week intervention period
Average number of sessions attended
Clinician's judgment of proportion of completion of at home assignments
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
Client Satisfaction Questionnaire-4 (CSQ-4)
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.
Reliable change
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).
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- San Diego, California
Collaborators
National Center for Complementary and Integrative Health (NCCIH)
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 2, 2026 · Source of record for eligibility and locations