Interoceptive Training Enhanced Mindfulness

NCT ID: NCT06786572

Last Updated: 2025-11-10

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-09-10
• Study Completion Date: 2027-03-31

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.

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.

Conditions

Anxiety Sensitivity

Keywords

anxiety sensitivity; mindfulness; interoception

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: OTHER
• Blinding Strategy: SINGLE

Study Groups

Interoceptive Training Enhanced Mindfulness (ITEM)

Brief mindfulness training focused on management of unwanted internal sensations

Group Type: EXPERIMENTAL

Mindfulness training

Intervention Type: OTHER

Brief mindfulness training focused on management of unwanted internal sensations

Interoceptive Exposure (IE)

Cognitive behavioral intervention featuring systematic exposure to unwanted internal sensations

Group Type: ACTIVE_COMPARATOR

Interoceptive exposure

Intervention Type: BEHAVIORAL

Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

Interventions

Mindfulness training

Brief mindfulness training focused on management of unwanted internal sensations

Intervention Type: OTHER

Interoceptive exposure

Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

Intervention Type: BEHAVIORAL

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Center for Complementary and Integrative Health (NCCIH)

NIH

Sponsor Role: collaborator

Veterans Medical Research Foundation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

VA San Diego Healthcare System

San Diego, California, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Ariel J Lang, PhD, MPH

Role: CONTACT

Phone: 8585528585

Email: ajlang@ucsd.edu

Jafer Vazquez Alcaraz

Role: CONTACT

Phone: 858-367-0243

Email: jafer.vazquezalcaraz@va.gov

Facility Contacts

Niloofar Afari

Role: primary

Other Identifiers

1R34AT012499-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

H230149

Identifier Type: -

Identifier Source: org_study_id