Recruiting

Mindfulness & Interoceptive Exposure

Sponsor:

Veterans Medical Research Foundation

Code:

NCT06786572

Conditions

Anxiety Sensitivity

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Mindfulness training

Interoceptive exposure

Study Details

Brief 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.

Conditions

Anxiety Sensitivity

Study ID

NCT06786572

Start date

Sep 10, 2025

Status verified date

Nov, 2025

Completion date

Mar 31, 2027

Anticipated

Primary completion date

Mar 31, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

48 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Other

Interventions and Outcome Measures

Arms

experimental: Interoceptive Training Enhanced Mindfulness (ITEM)

Brief mindfulness training focused on management of unwanted internal sensations

active comparator: Interoceptive Exposure (IE)

Cognitive behavioral intervention featuring systematic exposure to unwanted internal sensations

Interventions

Mindfulness training

Brief mindfulness training focused on management of unwanted internal sensations

Interoceptive exposure

Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

Primary outcome measure

  • Enrollment rate [ Time Frame: Typically up to 3 months, from initial referral to decision to enroll or not ]
  • Attendance [ Time Frame: During the six-week intervention period ]
  • Clinician's judgment of proportion of completion of at home assignments [ Time Frame: During the six-week intervention period ]
  • Client Satisfaction Questionnaire-4 (CSQ-4) [ Time Frame: Week 6, following the final treatment session ]
  • Reliable change [ Time Frame: Over a 6-8 week period from baseline to post-treatment ]

Central Contacts and Locations

Central contacts

Ariel J Lang, PhD, MPH

8585528585ariel.lang@va.gov

Jafer Vazquez Alcaraz

858-367-0243jafer.vazquezalcaraz@va.gov

Locations

VA San Diego Healthcare System

Recruiting

San Diego, California, United States, 92161

Contacts

Ariel Lang, PhD, MPH

8585528585ariel.lang@va.gov

More Information

Sponsor

Veterans Medical Research Foundation

Last update posted

Feb 2, 2026

Last verified

Nov, 2025

Keywords

  • anxiety sensitivity
  • mindfulness
  • interoception

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Veterans Medical Research Foundation on 2026-02-02.