Interoceptive Engagement

Stress Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03583060
• Other study ID #: STUDY00003441
• Status: Completed
• Phase: N/A
• Start date: May 1, 2018
• Est. completion date: November 1, 2018

Study information

• Verified date: May 2020
• Source: University of Washington
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 21
• Est. completion date: November 1, 2018
• Est. primary completion date: November 1, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Stress

Intervention

Behavioral:
• Mindful Awareness in body-oriented therapy
teaches interoceptive awareness skills for self care

Locations

Country	Name	City	State
United States	University of Washington	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
University of Washington

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	interoceptive function	Functional magnetic resonance imaging (fMRI)	10 weeks