Interoceptive Engagement

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.

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Key information

Conditions

Stress

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Washington

Seattle, Washington, 98195, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Mindful Awareness in Body-oriented Therapy

Behavioral

teaches interoceptive awareness skills for self care

Primary outcomes

interoceptive function

Time frame: 10 weeks

Functional magnetic resonance imaging (fMRI)

Sponsors and collaborators

Lead sponsor

University of Washington

Other

Registry information

Official study title

Interoceptive Engagement in Response to Mindful Awareness in Body-oriented Therapy: A Pilot Test Comparison

Important dates

Study start: 2018
Primary completion: 2018
Study completion: 2018
First posted: Jul 11, 2018
Registry last updated: May 13, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed