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Interoceptive Training Enhanced Mindfulness

NCT06786572 · Veterans Medical Research Foundation
In plain English

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Official title
Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement
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.
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
Study design
Enrollment target: 48 participants
Allocation: randomized
Masking: single
Age groups: adult, older_adult
Timeline
Starts: 2025-09-10
Estimated completion: 2027-03-31
Last updated: 2026-02-02
Interventions
Other: Mindfulness trainingBehavioral: Interoceptive exposure
Primary outcomes
  • Enrollment rate (Typically up to 3 months, from initial referral to decision to enroll or not)
  • Attendance (During the six-week intervention period)
  • Clinician's judgment of proportion of completion of at home assignments (During the six-week intervention period)
Sponsor
Veterans Medical Research Foundation · other
With: National Center for Complementary and Integrative Health (NCCIH)
Contacts & investigators
ContactAriel J Lang, PhD, MPH · contact · ariel.lang@va.gov · 8585528585
ContactJafer Vazquez Alcaraz · contact · jafer.vazquezalcaraz@va.gov · 858-367-0243
All locations (1)
VA San Diego Healthcare SystemRecruiting
San Diego, California, United States
Interoceptive Training Enhanced Mindfulness · TrialPath