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Interoceptive Training Enhanced Mindfulness

ConditionAnxiety Sensitivity
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorVeterans Medical Research Foundation

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Mindfulness training

    Other intervention

    Brief mindfulness training focused on management of unwanted internal sensations

  • Interoceptive exposure

    Behavioral

    Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations

Treatment groups

48 Participants
are divided into 2 treatment groups
Group A: Interoceptive Training Enhanced Mindfulness (ITEM)Experimental treatment 1 intervention
Group B: Interoceptive Exposure (IE)Active comparator 1 intervention

Trial outcomes

Primary outcomes

1

Enrollment rate

Number enrolled out of number approached

Time frame
Typically up to 3 months, from initial referral to decision to enroll or not
2

Attendance

Average number of sessions attended

Time frame
During the six-week intervention period
3

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

Time frame
During the six-week intervention period
4

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.

Time frame
Week 6, following the final treatment session

Secondary outcomes

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Veterans Medical Research Foundation

Lead sponsor

National Center for Complementary and Integrative Health (NCCIH)

Collaborator

Source ClinicalTrials.gov
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