Anorexia Nervosa Clinical Trial
Official title:
Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
NCT number | NCT06332963 |
Other study ID # | 2023-007 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | April 19, 2024 |
Est. completion date | December 2028 |
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.
Status | Recruiting |
Enrollment | 102 |
Est. completion date | December 2028 |
Est. primary completion date | June 2028 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 15 Years to 40 Years |
Eligibility | Inclusion Criteria: 1. Primary diagnosis of anorexia nervosa 2. Photographic Figure Rating Scale (PFRS) body dissatisfaction score > 1 3. Eating Disorder Examination Questionnaire (EDE-Q6) Shape Concern Subscale score > 3 4. Weight restored to body mass index (BMI) > 18.5 5. No current evidence of orthostatic hypotension 6. Clinical status transition from acute to residential status 7. No new psychiatric medications in the week prior to randomization 8. Female sex assigned at birth 9. Ages 15 to 40 years 10. Independently ambulatory 11. Ability to lay flat comfortably 12. English proficiency 13. Willingness and ability to participate in study procedures 14. Provision of informed consent (parent consent and minor assent if less than 18 years of age). Exclusion Criteria: 1. Active suicidal ideation with plan and intent 2. Active cutting or skin lacerating behaviors 3. Pregnancy as defined by urine screening 4. Acute intoxication as indicated by urine drug screen or breathalyzer 5. Orthostatic hypotension (defined as a drop of = 20 mmHg in systolic blood pressure (SBP) or a drop of = 10 mm Hg in diastolic blood pressure (DBP) when measured shortly after transitioning from lying down to standing) 6. Seizure reported within the previous 12 months 7. Co-morbid diagnoses of Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) bipolar disorder, schizophrenia, or other psychosis spectrum disorder 8. Systolic blood pressure > 160 mmHg 9. Diastolic blood pressure >100 mmHg 10. Resting heart rate <50 beats per minute. |
Country | Name | City | State |
---|---|---|---|
United States | Laureate Institute for Brain Research | Tulsa | Oklahoma |
Lead Sponsor | Collaborator |
---|---|
Laureate Institute for Brain Research, Inc. |
United States,
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) | 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) | Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion | |
Primary | Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS) | Average change in BID from pre- to post-intervention (range 0 - 9, larger changes indicate greater severity of BID). | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Cognitive/affective body image on the Body Image State Scale (BISS) | Average of the change in state cognitive affective body image state pre- to post-experimental sessions across all three sessions. Items 2,4,6 are reverse coded (range 1 to 9, higher scores indicate greater satisfaction with body image) | Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion | |
Secondary | Body image dissatisfaction on the Somatomap3D | Average of the change in anxiety rating from pre- to post-intervention sessions (measured in difference size estimation from Somatomap3D current to ideal in cm, larger discrepancy indicates greater body dissatisfaction) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | 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) | Average of the change in appearance evaluation rating from pre- to post-intervention sessions | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | 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) | Average of the change in appearance orientation rating from pre- to post-intervention sessions (range 12 to 60, higher scores indicate more importance placed on appearance). | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction | Average of the change in body image satisfaction rating from pre- to post-intervention sessions (scores range from 9 to 45, higher scores indicate more content with body appearance) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale | Average of the change in preoccupations with gaining weight from pre- to post-intervention sessions (scores range from 4 to 20, higher scores indicate higher preoccupation) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) | Average change in awareness of body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more self-reported awareness of body sensations) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) | Average change in extent one distracts from unpleasant sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more adaptive response to unpleasant body sensations) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) | Average change in extent one worries about unpleasant physical sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate less rumination about unpleasant body sensations) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) | Average change in ability to sustain and control attention to body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate less rumination about unpleasant body sensations) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) | Average change in ability to awareness and connection between body and emotional states from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more awareness of the connection between emotion and body states) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) | Average change in ability to regulate distress through attention to body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more regulation) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2) | Average change in experiences of one's body as safe and trustworthy ability to regulate distress through attention to body sensations from pre- to post-intervention sessions (scores range from 0 to 5, higher scores indicate more trust in body) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Interoceptive attention on the Interoceptive Attention Scale (IATS) | Average change in attention to interoceptive signals from pre- to post-intervention sessions (scores range from 21 to 105, higher scores indicate greater self-reported attention to internal signals) | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Cardiac interoceptive accuracy on the Heartbeat Tapping Task | Beat-to-tap consistency measure of the Heartbeat Tapping Task, higher values indicate greater consistency between actual heartbeats and perceived heartbeats. | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Cardiac interoceptive intensity on the Heartbeat Tapping Task | Intensity of cardiac signals measured via visual analog scale during the Heartbeat Tapping Task, higher values indicate greater intensity of perceived heartbeats. | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Interoceptive intensity during experimental conditions | Intensity of cardiac, respiratory, and gastric signals measured via visual analog scale pre-to -post experimental conditions, higher values indicate greater intensity | Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion | |
Secondary | Perceived respiratory interoceptive intensity on the Breath Hold Task | Intensity of panic, suffocation, and anxiety during breath hold task measured via visual analog scale pre-to -post experimental conditions, higher values indicate greater intensity | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Body image distortion on the Aperture Task | Absolute difference between perceived size gap to fit through the aperture and actual shoulder width to pass through | Through completion of post-intervention follow-up, within 2 weeks of final intervention | |
Secondary | Body image distortion on the String task | Sum of the absolute difference between perceived body part size measured via string task and actual body size | Through completion of post-intervention follow-up, within 2 weeks of final intervention |
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