Clinical trial NCT03583060: Interoceptive Engagement
Official title: Interoceptive Engagement in Response to Mindful Awareness in Body-oriented Therapy: A Pilot Test Comparison
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Stress
Lead sponsor: University of Washington
Sponsor class: OTHER
First posted: 2018-07-11
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

Brief summary: The proposed project is the first pilot test to examine interoceptive function as a mechanistic biomarker underlying Mindful Awareness in Body-oriented Therapy (MABT). MABT, an empirically-validated and manualized protocol is explicitly designed to teach interoceptive awareness skills for emotion regulation and is thus an ideal intervention approach in which to address this gap in research. This study uses a two group, randomized design to examine neural and physiological biomarkers in response to MABT. Twenty-four individuals reporting moderate stress will be recruited from the community and randomized to 8-week MABT intervention or the control condition. The study aims are to: 1) evaluate whether interoceptive training improves interoceptive function in the MABT vs control condition, and 2) explore whether changes in interoceptive function correlate with improved health outcomes. Analyses will include within and between-group ANOVA of brain activity with symptom change as a covariate. This is the first study to test whether a clinical intervention aimed specifically at cultivating interoceptive awareness effects change on interoceptive biomarkers. The results will support larger NIH proposals to more comprehensively validate neuro and behavioral biomarkers of interoceptive training to enhance mental health, particularly targeting depression and substance use disorder that have identified interoceptive dysfunction and poor emotion regulation.


Eligibility criteria: Inclusion Criteria:

* adult (over 18)
* Perceived Stress Scale scores indicating moderate stress levels
* naive to mindfulness-based approaches (no prior experience)
* agrees to forgo (non-study) manual therapies (e.g., massage) and mind-body therapies (e.g., mindfulness meditation) for 3 months (baseline to post-test)
* fluent in English
* can attend MABT and assessment sessions
* right-handed (for uniformity of neuroimaging results)

Exclusion Criteria:

* lifetime diagnosis of mental health disorder
* unable to complete study participation (includes planned relocation, pending inpatient treatment, planned extensive surgical procedures, etc.)
* cognitive impairment, assessed by the Mini-Mental Status Exam (MMSE) if demonstrated difficulty comprehending the consent
* use of medications in the past 30 days that affect hemodynamic response
* lifetime head injuries or loss of consciousness longer than 5 min
* currently pregnant
* contraindications for MRI, e.g., claustrophobia, metal objects in body, etc.

Primary outcomes:
measure: interoceptive function
timeFrame: 10 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Seattle
country: United States
facility: University of Washington
state: Washington
Study officials:
affiliation: University of Washington
name: Cynthia Price, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Toronto
name: Norman Farb, PhD
role: PRINCIPAL_INVESTIGATOR
References: