Interoceptive Engagement

Not Applicable

Completed

• Conditions: Stress
• Interventions: Behavioral: Mindful Awareness in body-oriented therapy

• Registration Number: NCT03583060
• Lead Sponsor: University of Washington

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-05-01
• Study First Submitted: 2018-06-26
• Study First Submitted QC: 2018-07-09
• Study First Posted: 2018-07-11
• Primary Completion: 2018-11-01
• Study Completion: 2018-11-01
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-11
• Last Update Posted: 2020-05-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 21

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MABT	Mindful Awareness in body-oriented therapy	Receive 8 weekly sessions of Mindful Awareness in Body-oriented Therapy (MABT).

Primary Outcome Measures

Name	Time	Method
interoceptive function	10 weeks	Functional magnetic resonance imaging (fMRI)

Trial Locations

Locations (1)

University of Washington; 🇺🇸 Seattle, Washington, United States