nctId: NCT06332963 id: 2023-007 briefTitle: Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa overallStatus: NOT_YET_RECRUITING date: 2024-04 date: 2028-06 date: 2028-12 date: 2024-03-27 date: 2024-03-27 name: Laureate Institute for Brain Research, Inc. class: OTHER 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. conditions: Anorexia Nervosa conditions: Body Image Disturbance conditions: Interoception studyType: INTERVENTIONAL phases: NA allocation: RANDOMIZED interventionModel: PARALLEL interventionModelDescription: Equal groups parallel randomized clinical trial primaryPurpose: TREATMENT masking: NONE count: 102 type: ESTIMATED name: Floatation-REST name: IFT name: EFT measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) measure: Cognitive/affective body image on the Body Image State Scale (BISS) measure: Body image dissatisfaction on the Somatomap3D 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) 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) measure: Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction measure: Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale measure: Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) measure: Interoceptive attention on the Interoceptive Attention Scale (IATS) measure: Cardiac interoceptive accuracy on the Heartbeat Tapping Task measure: Cardiac interoceptive intensity on the Heartbeat Tapping Task measure: Interoceptive intensity during experimental conditions measure: Perceived respiratory interoceptive intensity on the Breath Hold Task measure: Body image distortion on the Aperture Task measure: Body image distortion on the String task sex: FEMALE minimumAge: 15 Years maximumAge: 40 Years stdAges: CHILD stdAges: ADULT hasResults: False