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NCT Number: NCT06786572

Interoceptive Training Enhanced Mindfulness

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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

VA San Diego Healthcare System

San Diego, California, 92161, United States

Location status: Recruiting

Location contact

Ariel Lang, PhD, MPH

CONTACT

[email protected]

8585528585

Niloofar Afari, PhD

CONTACT

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Mindfulness training

Other

Brief mindfulness training focused on management of unwanted internal sensations

Interoceptive exposure

Behavioral

Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

Primary outcomes

  1. Enrollment rate

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

    Number enrolled out of number approached

  2. Attendance

    Time frame: During the six-week intervention period

    Average number of sessions attended

  3. Clinician's judgment of proportion of completion of at home assignments

    Time frame: During the six-week intervention period

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

  4. Client Satisfaction Questionnaire-4 (CSQ-4)

    Time frame: Week 6, following the final treatment session

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

  5. Reliable change

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ariel J Lang, PhD, MPH

CONTACT

[email protected]

8585528585 ext. x5359

Jafer Vazquez Alcaraz

CONTACT

[email protected]

858-367-0243

Sponsors and collaborators

Lead sponsor

Veterans Medical Research Foundation

Other

Collaborators

  • National Center for Complementary and Integrative Health (NCCIH)

Registry information

Official study title

Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement

Acronym: ITEM

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 22, 2025
Registry last updated
Feb 2, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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