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NCT06332963 · ClinicalTrials.gov registry record · NA
Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
A NA study of Anorexia Nervosa and Body Image Disturbance, sponsored by Laureate Institute for Brain Research.
- Recruiting
- Registry status
- NA
- Development phase
- 102
- Enrollment target
- 1
- Study location
NCT06332963: Recruiting NA study of Anorexia Nervosa and Body Image Disturbance, sponsored by Laureate Institute for Brain Research.
NCT06332963 is a NA study of Anorexia Nervosa and Body Image Disturbance that is actively recruiting participants, run by Laureate Institute for Brain Research. The registered enrollment target is 102 participants, below the 948-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (89% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06332963, a NA study of Anorexia Nervosa and Body Image Disturbance, is actively recruiting participants, sponsored by Laureate Institute for Brain Research.
- RECRUITING
- Registry status
- NA
- Development phase
- 102 participants
- Enrollment target
- 1
- Study location
Study Summary
The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of 102 participants will be recruited from the Laureate Eating Disorder Program (LEDP). After being randomized, participants will all receive a one-hour session of acceptance- and mindfulness-based training with a therapist (the introduction session). They will then receive either the interoceptively focused treatment (IFT) or exteroceptively focused treatment (EFT) condition based on randomization. In the IFT condition participants will engage in floatation-REST (Reduced Environmental Stimulation Therapy) while practicing acceptance and mindfulness-based principles. The EFT condition is an exteroceptive intervention in which participants will be asked to view pre-recorded videos of acceptance and mindfulness-based skills to aid in the practice of these skills. Each condition will consist of one introduction session and three experimental sessions. All participants will then return for follow-up measures. Assessed outcomes will include acute changes in body image disturbance (BID) and interoception. Further, longitudinal intervention effects on self-reported eating disorder symptoms, body image dissatisfaction, and interoception; behavioral measures of interoception and body image dissatisfaction; and resting state and interoceptive functioning during functional magnetic resonance imaging (fMRI) will be explored.
Primary Outcome
Average change in acute body image dissatisfaction from pre- to post-experimental sessions across all three sessions (range 0 - 9, larger changes indicate greater severity of BID)
Conditions Studied
Interventions
- BEHAVIORAL EFT
- BEHAVIORAL Floatation-REST
- BEHAVIORAL IFT
Study Locations (1)
Oklahoma
- Laureate Institute for Brain Research - Tulsa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 102 participants |
| Start Date | 2024-04-19 |
| Est. Completion | 2028-12 |
| Phase | NA |
What NCT06332963 shows while recruiting
NCT06332963 is an interventional study that assigns participants to a tested intervention. The registered 102 participants enrollment target is mid-sized for trials with a published cap, below the 948-participant average among 43 other Anorexia Nervosa trials with a reported enrollment target (89% lower).
The record links to 3 conditions, with Anorexia Nervosa appearing as the primary indexed condition, and to 3 interventions - of which EFT is the first listed.
NCT06332963 reports a single indexed study location in Oklahoma.
Frequently Asked Questions
What is clinical trial NCT06332963 about?
NCT06332963 is a clinical study titled "Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa". The proposed study utilizes a randomized experimental therapeutics design to test a mechanistic framework linking interoceptive processing and disturbed body image, with the purpose of informing the development of future therapies for body image dissatisfaction in anorexia nervosa (AN). A sample of ...
What is the current status of trial NCT06332963?
This trial is currently recruiting. It is a NA study. The enrollment target is 102 participants. The study started on 2024-04-19. Estimated completion is 2028-12.
What conditions does trial NCT06332963 study?
This clinical trial studies the following conditions: Anorexia Nervosa, Body Image Disturbance, Interoception.
What interventions are being tested in trial NCT06332963?
The interventions under investigation include: EFT (BEHAVIORAL), Floatation-REST (BEHAVIORAL), IFT (BEHAVIORAL).
Who is sponsoring clinical trial NCT06332963?
This trial is sponsored by Laureate Institute for Brain Research, which has 45 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06332963 being conducted?
This trial has 1 study location across Oklahoma. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06332963's enrollment target sits among peer trials
102 9th of 43 higher than 35 of 43 other Anorexia Nervosa trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Anorexia Nervosa trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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