NCT06786572

Interoceptive Training Enhanced Mindfulness

Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 48 (estimated)
• Sponsor: Veterans Medical Research Foundation · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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

Timeline

• Start date: 2025-09-10
• Primary completion: 2027-03-31
• Completion: 2027-03-31
• First posted: 2025-01-22
• Last updated: 2026-02-02

Locations

1 site across 1 country: United States