Interoceptive Engagement

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

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.

Study Overview

• Status: Completed
• Conditions: Stress
• Intervention / Treatment: Behavioral: Mindful Awareness in body-oriented therapy

• Study Type: Interventional
• Enrollment (Actual): 21
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98195
      • University of Washington

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: BASIC_SCIENCE
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: SINGLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
NO_INTERVENTION: Control
EXPERIMENTAL: MABT; Receive 8 weekly sessions of Mindful Awareness in Body-oriented Therapy (MABT).	Behavioral: Mindful Awareness in body-oriented therapy; teaches interoceptive awareness skills for self care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
interoceptive function	Functional magnetic resonance imaging (fMRI)	10 weeks

Collaborators and Investigators

• Sponsor: University of Washington
• Investigators: Principal Investigator: Norman Farb, PhD, University of Toronto

Study record dates

Study Major Dates

• Study Start (ACTUAL): May 1, 2018
• Primary Completion (ACTUAL): November 1, 2018
• Study Completion (ACTUAL): November 1, 2018

Study Registration Dates

• First Submitted: June 26, 2018
• First Submitted That Met QC Criteria: July 9, 2018
• First Posted (ACTUAL): July 11, 2018

Study Record Updates

• Last Update Posted (ACTUAL): May 13, 2020
• Last Update Submitted That Met QC Criteria: May 11, 2020
• Last Verified: May 1, 2020

More Information

Terms related to this study

• Other Study ID Numbers: STUDY00003441

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No