Interoceptive Training Enhanced Mindfulness (ITEM)

Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement

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.

Study Overview

• Status: Recruiting
• Conditions: Anxiety Sensitivity
• Intervention / Treatment: Other: Mindfulness training; Behavioral: Interoceptive exposure

Detailed Description

Anxiety sensitivity (AS), which involves fear that arousal related symptoms will have negative physical, social or psychological ramifications, is an important driver of anxiety, trauma-related and somatic disorders. Cognitive behavioral therapy (CBT), particularly involving interoceptive exposure (IE; i.e., exposure to unwanted internal sensations), has the greatest demonstrated efficacy at reducing AS but can be hard to tolerate. Conversely, mindfulness is sought out for management of multiple mental health problems, but the observed clinical effects are often modest. A hybrid of these two approaches may capitalize on the strengths of each approach. Mindfulness training (MT) may increase the tolerability of exposure, enhance compliance and support extinction learning through increased engagement with the feared stimulus and heightened awareness of the nonoccurrence of feared outcomes. This project will evaluate the feasibility and acceptability of a novel hybrid intervention, Interoceptive Training Enhanced Mindfulness (ITEM), which combines IE with MT, evaluate its feasibility and acceptability. Forty-eight Veterans will be randomized to receive ITEM or IE in six one-on-one sessions delivered via telehealth. They will complete assessments before and after the 6-week intervention period. Outcomes related to engagement and compliance with ITEM and IE will be the primary focus. Because multiple mental health (e.g., anxiety, posttraumatic stress disorder, eating disorders and depression) and physical health (e.g., chronic pain, conditions related to toxic exposure) problems are driven by maladaptive reactions to interoceptive cues, this intervention has the potential to ultimately produce wide-spread mental and physical health benefits.

• Study Type: Interventional
• Enrollment (Estimated): 48
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Jafer Vazquez Alcaraz; Phone Number: 858-367-0243; Email: jafer.vazquezalcaraz@va.gov
• Study Contact Backup: Name: Ariel J Lang, PhD, MPH; Phone Number: x5359 8585528585; Email: ariel.lang@va.gov

Study Locations

• United States
  • California
    • San Diego, California, United States, 92161
      • Recruiting
      • VA San Diego Healthcare System
      • Contact: Ariel Lang, PhD, MPH; Phone Number: 8585528585; Email: ariel.lang@va.gov
      • Contact: Niloofar Afari, PhD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Interoceptive Training Enhanced Mindfulness (ITEM); Brief mindfulness training focused on management of unwanted internal sensations	Other: Mindfulness training; 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	Behavioral: Interoceptive exposure; Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): September 10, 2025
• Primary Completion (Estimated): March 31, 2027
• Study Completion (Estimated): March 31, 2027

Study Registration Dates

• First Submitted: January 6, 2025
• First Submitted That Met QC Criteria: January 15, 2025
• First Posted (Actual): January 22, 2025

Study Record Updates

• Last Update Posted (Actual): February 2, 2026
• Last Update Submitted That Met QC Criteria: January 28, 2026
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Keywords: mindfulness; interoception; anxiety sensitivity
• Additional Relevant MeSH Terms: Immune System Diseases; Hypersensitivity
• Other Study ID Numbers: H230149; 1R34AT012499-01A1 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Final datasets in machine-readable format will be shared via PubMed Central
• IPD Sharing Time Frame: Available 3/31/28, indefinite
• IPD Sharing Access Criteria: Public access
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; ICF

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No