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NCT03583060 · ClinicalTrials.gov registry record · NA
Interoceptive Engagement
A NA study, sponsored by University of Washington.
- Completed
- Registry status
- NA
- Development phase
- 21
- Enrollment target
NCT03583060 is a NA study that has completed, run by University of Washington. The registered enrollment target is 21 participants.
The verdict
NCT03583060, a NA study, has completed, sponsored by University of Washington.
- COMPLETED
- Registry status
- NA
- Development phase
- 21 participants
- Enrollment target
Study 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.
Interventions
- BEHAVIORAL Mindful Awareness in body-oriented therapy
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 21 participants |
| Start Date | 2018-05-01 |
| Est. Completion | 2018-11-01 |
| Phase | NA |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03583060
The ClinicalTrials.gov registry entry for NCT03583060 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 21 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Washington, which has 1,048 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which Mindful Awareness in body-oriented therapy is the first listed.
NCT03583060 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT03583060 about?
NCT03583060 is a clinical study titled "Interoceptive Engagement". 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 re...
What is the current status of trial NCT03583060?
This trial is currently completed. It is a NA study. The enrollment target is 21 participants. The study started on 2018-05-01. Estimated completion is 2018-11-01.
What interventions are being tested in trial NCT03583060?
The interventions under investigation include: Mindful Awareness in body-oriented therapy (BEHAVIORAL).
Who is sponsoring clinical trial NCT03583060?
This trial is sponsored by University of Washington, which has 1,048 total clinical trials registered on ClinicalTrials.gov.
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