Clinical trial NCT06786572: Interoceptive Training Enhanced Mindfulness
Official title: Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Anxiety Sensitivity
Keywords: anxiety sensitivity
mindfulness
interoception
Lead sponsor: Veterans Medical Research Foundation
Sponsor class: OTHER
Collaborators: name: National Center for Complementary and Integrative Health (NCCIH)
First posted: 2025-01-22
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: OTHER

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.

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 4 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

Primary outcomes:
measure: Enrollment rate
timeFrame: Typically up to 3 months, from initial referral to decision to enroll or not
measure: Attendance
timeFrame: During the six-week intervention period
measure: Homework compliance
timeFrame: During the six-week intervention period
measure: Credibility as measured by 3 questions designed for the study
timeFrame: Week 1, following session 1
measure: Client Satisfaction Questionnaire-4 (CSQ-4)
timeFrame: Week 6, following the final treatment session
measure: Reliable change
timeFrame: Over a 6-8 week period from baseline to post-treatment
Secondary outcomes:
Other outcomes:
Locations:
city: San Diego
country: United States
facility: VA San Diego Healthcare System
state: California
Study officials:
References: