Interoceptive Engagement

NCT03583060 | Completed

• 1 other identifier: STUDY00003441
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Stress

Outcome Measures

Primary Outcomes (1)

• interoceptive function

  Functional magnetic resonance imaging (fMRI)

  10 weeks

Study Arms (2)

MABT

EXPERIMENTAL

Receive 8 weekly sessions of Mindful Awareness in Body-oriented Therapy (MABT).

Behavioral: Mindful Awareness in body-oriented therapy

Control

NO INTERVENTION

Interventions

Mindful Awareness in body-oriented therapy BEHAVIORAL

teaches interoceptive awareness skills for self care

MABT

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Washington: lead

Study Sites (1)

University of Washington

Seattle, Washington, 98195, United States

Location

Study Officials

• Cynthia Price, PhD

  University of Washington

  PRINCIPAL INVESTIGATOR

• Norman Farb, PhD

  University of Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Research Assoc. Professor

Study Record Dates

• First Submitted: June 26, 2018
• First Posted: July 11, 2018
• Study Start: May 1, 2018
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: May 13, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)