Interoceptive Engagement

NCT ID: NCT03583060

Last Updated: 2020-05-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 21 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-01
• Study Completion Date: 2018-11-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: SINGLE

Study Groups

MABT

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

Group Type: EXPERIMENTAL

Mindful Awareness in body-oriented therapy

Intervention Type: BEHAVIORAL

teaches interoceptive awareness skills for self care

Control

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Mindful Awareness in body-oriented therapy

teaches interoceptive awareness skills for self care

Intervention Type: BEHAVIORAL

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

University of Washington

OTHER

Sponsor Role: lead

Responsible Party

Cynthia Price

Research Assoc. Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Cynthia Price, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Washington

Norman Farb, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Toronto

Locations

University of Washington

Seattle, Washington, United States

Countries

United States

Other Identifiers

STUDY00003441

Identifier Type: -

Identifier Source: org_study_id