Anxiety Sensitivity
Conditions
Keywords
anxiety sensitivity, mindfulness, interoception
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.
Interventions
OTHERMindfulness training
Brief mindfulness training focused on management of unwanted internal sensations
BEHAVIORALInteroceptive exposure
Cognitive behavioral therapy focused in interoceptive exposure to unwanted internal sensations
Sponsors
Veterans Medical Research Foundation
National Center for Complementary and Integrative Health (NCCIH)
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
SINGLE (Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Enrollment rate | Typically up to 3 months, from initial referral to decision to enroll or not | Number enrolled out of number approached |
| Attendance | During the six-week intervention period | Average number of sessions attended |
| Clinician's judgment of proportion of completion of at home assignments | 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) | 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 | 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). |
Countries
United States
Contacts
CONTACTAriel J Lang, PhD, MPH
CONTACTJafer Vazquez Alcaraz
Outcome results
None listed