protocolSection identificationModule nctId: NCT06332963, orgStudyIdInfo id: 2023-007, briefTitle: Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04, primaryCompletionDateStruct date: 2028-06, completionDateStruct date: 2028-12, studyFirstPostDateStruct date: 2024-03-27, lastUpdatePostDateStruct date: 2024-03-27, sponsorCollaboratorsModule leadSponsor name: Laureate Institute for Brain Research, Inc., class: OTHER, descriptionModule briefSummary: 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., conditionsModule conditions: Anorexia Nervosa, conditions: Body Image Disturbance, conditions: Interoception, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Equal groups parallel randomized clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 102, type: ESTIMATED, armsInterventionsModule interventions name: Floatation-REST, interventions name: IFT, interventions name: EFT, outcomesModule primaryOutcomes measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS), primaryOutcomes measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS), secondaryOutcomes measure: Cognitive/affective body image on the Body Image State Scale (BISS), secondaryOutcomes measure: Body image dissatisfaction on the Somatomap3D, secondaryOutcomes measure: Appearance evaluation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Evaluation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance), secondaryOutcomes measure: Appearance orientation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Appearance Orientation Subscale (range 7 to 35, higher scores indicate more satisfaction with appearance), secondaryOutcomes measure: Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction, secondaryOutcomes measure: Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale, secondaryOutcomes measure: Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2), secondaryOutcomes measure: Interoceptive attention on the Interoceptive Attention Scale (IATS), secondaryOutcomes measure: Cardiac interoceptive accuracy on the Heartbeat Tapping Task, secondaryOutcomes measure: Cardiac interoceptive intensity on the Heartbeat Tapping Task, secondaryOutcomes measure: Interoceptive intensity during experimental conditions, secondaryOutcomes measure: Perceived respiratory interoceptive intensity on the Breath Hold Task, secondaryOutcomes measure: Body image distortion on the Aperture Task, secondaryOutcomes measure: Body image distortion on the String task, eligibilityModule sex: FEMALE, minimumAge: 15 Years, maximumAge: 40 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule, hasResults: False