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Interoceptive Engagement

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03583060
Enrollment
21
Registered
2018-07-11
Start date
2018-05-01
Completion date
2018-11-01
Last updated
2020-05-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stress

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.

Interventions

teaches interoceptive awareness skills for self care

Sponsors

University of Washington
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
BASIC_SCIENCE
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
interoceptive function10 weeksFunctional magnetic resonance imaging (fMRI)

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026