Anxiety SensitivityITEMNCT06786572
Interoceptive Training Enhanced Mindfulness
A study testing Mindfulness training and Interoceptive exposure in people with Anxiety Sensitivity, run by Veterans Medical Research Foundation at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Anxiety Sensitivity
- What is being tested?
- Mindfulness training and Interoceptive exposure
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Sep 2025to 31 Mar 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
VA San Diego Healthcare System
San Diego, California, 92161
Ariel Lang, PhD, MPH, 8585528585, ariel.lang@va.gov
Niloofar Afari, PhD
About this study
Official title: Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement
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.
Read the 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
- Being tested
- Mindfulness training, Interoceptive exposure
- Keywords
- anxiety sensitivity, mindfulness, interoception
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindfulness trainingOther
Brief mindfulness training focused on management of unwanted internal sensations
Interoceptive exposureBehavioural
Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations
| Study group | Role | What they receive |
|---|---|---|
| Interoceptive Training Enhanced Mindfulness (ITEM) | Experimental | Brief mindfulness training focused on management of unwanted internal sensations Receives: Other: Mindfulness training |
| Interoceptive Exposure (IE) | Active comparator | Cognitive behavioral intervention featuring systematic exposure to unwanted internal sensations Receives: Behavioral: Interoceptive exposure |
What is being measured
The primary outcome is the main question the study is designed to answer.
Enrollment rate
Number enrolled out of number approached
Measured: Typically up to 3 months, from initial referral to decision to enroll or not
Attendance
Average number of sessions attended
Measured: During the six-week intervention period
Clinician's judgment of proportion of completion of at home assignments
Clinician's judgment of proportion of completion of at home assignments on a scale including none, partial and complete
Measured: During the six-week intervention period
Client Satisfaction Questionnaire-4 (CSQ-4)
The CSQ-4 is a validated measure of participant satisfaction with care delivered with higher scores (range 4-16) indicating greater satisfaction.
Measured: Week 6, following the final treatment session
Reliable change
Proportion improved, unchanged and worsened based on the Reliable Change Index using the Overall Anxiety Symptoms and Impairment Scale (OASIS).
Measured: Over a 6-8 week period from baseline to post-treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jan 2025
- Study start10 Sep 2025
- Primary completion31 Mar 2027 (estimated)
- Study completion31 Mar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Anxiety SensitivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Veterans Medical Research Foundation
- Sponsor type
- University, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06786572
- Sponsor's protocol ID
- H230149
- Other IDs
- 1R34AT012499-01A1
- Acronym
- ITEM
- Status last verified
- Nov 2025
- First submitted
- 6 Jan 2025
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Final datasets in machine-readable format will be shared via PubMed Central
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interoceptive Training Enhanced Mindfulness (ITEM): Acceptability and Measurement
- ClinicalTrials.gov ID
- NCT06786572
- Acronym / sponsor ID
- ITEM / H230149
- Conditions
- Anxiety Sensitivity
- Keywords
- anxiety sensitivity, mindfulness, interoception
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Veterans Medical Research FoundationUniversity, hospital or other
- Collaborators
- National Center for Complementary and Integrative Health (NCCIH)
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 31 Mar 2027 (estimated)
- Study completion
- 31 Mar 2027 (estimated)
- First posted
- 22 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Interoceptive Training Enhanced Mindfulness (ITEM) | Experimental | Other: Mindfulness trainingBrief mindfulness training focused on management of unwanted internal sensations |
| Interoceptive Exposure (IE) | Active comparator | Behavioral: Interoceptive exposureCognitive behavioral intervention featuring systematic exposure to unwanted internal sensations |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Mindfulness trainingBrief mindfulness training focused on management of unwanted internal sensations | Other | Interoceptive Training Enhanced Mindfulness (ITEM) |
| Interoceptive exposureCognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations | Behavioural | Interoceptive Exposure (IE) |
Primary outcome
Enrollment rate
Time frame: Typically up to 3 months, from initial referral to decision to enroll or not
Number enrolled out of number approached
Attendance
Time frame: During the six-week intervention period
Average number of sessions attended
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
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.
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).
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Feb 2026.
- Individual participant dataSharing planned: Yes. Final datasets in machine-readable format will be shared via PubMed Central
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindfulness training and Interoceptive exposure in people with Anxiety Sensitivity, run by Veterans Medical Research Foundation at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Ariel J Lang, PhD, MPH (8585528585 ext. x5359, ariel.lang@va.gov), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Enrollment rate (time frame: Typically up to 3 months, from initial referral to decision to enroll or not). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Feb 2026.