Interoceptive Training Enhanced Mindfulness

NCT06786572 | Recruiting DMC

• 2 other identifiers: H2301491R34AT012499-01A1
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 1

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

Keywords

anxiety sensitivity; mindfulness; interoception

Outcome Measures

Primary Outcomes (5)

• Enrollment rate

  Number enrolled out of number approached

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

• Attendance

  Average number of sessions attended

  During the six-week intervention period

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

  Clinician's judgment of proportion of completion of at home assignments on a scale including none, partial and complete

  During the six-week intervention period

• Client Satisfaction Questionnaire-4 (CSQ-4)

  The CSQ-4 is a validated measure of participant satisfaction with care delivered with higher scores (range 4-16) indicating greater satisfaction.

  Week 6, following the final treatment session

• Reliable change

  Proportion improved, unchanged and worsened based on the Reliable Change Index using the Overall Anxiety Symptoms and Impairment Scale (OASIS).

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

Study Arms (2)

Interoceptive Training Enhanced Mindfulness (ITEM)

EXPERIMENTAL

Brief mindfulness training focused on management of unwanted internal sensations

Other: Mindfulness training

Interoceptive Exposure (IE)

ACTIVE COMPARATOR

Cognitive behavioral intervention featuring systematic exposure to unwanted internal sensations

Behavioral: Interoceptive exposure

Interventions

Mindfulness training OTHER

Brief mindfulness training focused on management of unwanted internal sensations

Interoceptive Training Enhanced Mindfulness (ITEM)

Interoceptive exposure BEHAVIORAL

Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

Interoceptive Exposure (IE)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Veterans Medical Research Foundation: lead
• National Center for Complementary and Integrative Health (NCCIH): collaborator

Study Sites (1)

VA San Diego Healthcare System

San Diego, California, 92161, United States

RECRUITING

Central Study Contacts

Ariel J Lang, PhD, MPH

CONTACT

8585528585; ariel.lang@va.gov

Jafer Vazquez Alcaraz

CONTACT

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 6, 2025
• First Posted: January 22, 2025
• Study Start: September 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027
• Last Updated: February 2, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Available 3/31/28, indefinite
• Access Criteria: Public access

Locations

US (1)