Clinical trial NCT06332963: Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
Official title: Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Anorexia Nervosa
Body Image Disturbance
Interoception
Keywords: Anorexia Nervosa
Body Image Disturbance
Perceptual Body Image
Interoception
Acceptance Based Intervention
Mindfulness Based Intervention
Randomized Clinical Trial
Lead sponsor: Laureate Institute for Brain Research, Inc.
Sponsor class: OTHER
First posted: 2024-03-27
Enrollment: 102
Sex: FEMALE
Minimum age (years): 15
Maximum age (years): 40
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Equal groups parallel randomized clinical trial
Primary purpose: TREATMENT

Brief 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.

Detailed description: Anorexia nervosa (AN) accounts for more than 10,000 deaths per year in the United States alone, marking it as a psychiatric disorder with one of the highest standardized mortality rates. Current AN treatments have only moderate efficacy and result in relapse rates as high as 50% within one year of hospitalization. A poor understanding of the pathophysiology of AN, particularly the core diagnostic feature of body image disturbance (BID), has hindered treatment development. Abnormal interoceptive processing (i.e., internal body signal) has been proposed to contribute to BID and a mechanistic delineation of the association between interoception and BID could lead to novel interventions for AN. This proposal uses a behavioral experimental therapeutics approach to determine how modulating interoceptive processing affects BID in AN.

Body image, defined as the multifaceted experience of one's physical appearance, is comprised of cognitive, affective, and perceptual components. BID is a key diagnostic feature of AN that is associated with poor outcomes, including relapse following hospital discharge. It is slow to improve in women with AN, and has been consistently identified as a factor contributing to the persistence of AN symptoms and relapse following treatment.

Perceptual BID is a complex and poorly understood facet proposed to involve the integration of body-related visual signals with representations of interoceptive signals. Studies indicate women with AN overestimate their body size. Standard of care treatments for AN, such as Cognitive Behavioral Therapy, focus on modifying the cognitive/affective components of BID but rarely address the perceptual component, making it an under-investigated therapeutic target.

Diminished sensitivity to interoceptive body signals in AN may lead to an overreliance on exteroceptive (i.e., visual) body-related signals, which in turn, is likely to facilitate self-objectification (seeing one's body as an object). The outcome of this process is an inaccurate representation of physical body characteristics (i.e., perceiving one's body as larger than its true size) despite continuing to focus on it excessively. To explore whether the modulation of interoceptive signaling could improve perceptual BID in AN, we recently utilized a non-pharmacologic intervention called floatation-REST (Reduced Environmental Stimulation Therapy). During floatation-REST, input from visual, auditory, olfactory, gustatory, thermal, tactile, vestibular and proprioceptive channels are minimized, and interoceptive input is enhanced. Across two clinical trials in AN we have found that floatation-REST acutely reduces perceptual BID, indexed by the body dissatisfaction score on the Photographic Figure Rating Scale (PFRS), after one session and reliably after multiple sessions.

Acceptance and commitment therapy (ACT) for eating disorders and body image has been examined previously and evidence supports the reduction of cognitive/affective BID symptoms. The proposed study will combine floatation-REST with interoceptively focused acceptance- and mindfulness-based components (interoceptively focused therapy \[IFT\]). The primary purpose of the proposed study is to examine the acute synergistic effects of IFT and float on BID. Further, the proposed study will be the first to systematically examine associations between BID and interoception using multiple levels of analysis (i.e., self-report and behavioral assays and neuroimaging) and combine them with perturbations of interoceptive and cognitive processing to examine the impact of interoception on perceptual BID. All participants will receive a one-hour introduction session prior to being randomized on a 1:1 basis to receive three 45-minute floatation-REST sessions (to attenuate exteroceptive input and enhance interoceptive input) paired with IFT or three 45-minute self-guided exteroceptive practice sessions (active comparator to enhance cognitive/affective BID, EFT group). During the IFT/EFT sessions the skills presented have been matched as closely as possible with the exception of the focus. For example, both groups engage in contact with the present moment exercises. In the IFT group, the focus is internal body sensations; whereas in the EFT group, the focus in the experience outside the individual (e.g., their environment sights, sounds, etc). While ACT is typically conducted in longer intervals (10+ weeks of 1 hour sessions), there is growing evidence to support the potential of briefer ACT interventions.

Both groups will complete behavioral and self-report assays of interoception, perceptual and cognitive/affective BID, and state/trait illness measures pre- and post-experimental session; pre and post intervention measures including self-report, behavioral, and neurobiological assays (specifically functional magnetic resonance imaging); and longitudinal follow-ups. The ability to reliably improve BID marks a step forward in the search for more effective BID treatments for AN. Given that it is expected that acceptance and mindfulness-based components will impact affective components of body image, it is expected that there will be an additive effect on the primary outcome (perceptual BID).

Eligibility criteria: Inclusion Criteria:

1. Primary diagnosis of anorexia nervosa
2. Photographic Figure Rating Scale (PFRS) body dissatisfaction score greater than or equal to 1
3. Eating Disorder Examination Questionnaire (EDE-Q6) Shape Concern Subscale score greater than or equal to 3
4. Weight restored to body mass index (BMI) greater than or equal to 17.5
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 \&amp;amp;gt; 160 mmHg
9. Diastolic blood pressure \&amp;amp;gt;100 mmHg
10. Resting heart rate \&amp;amp;lt;50 beats per minute.

Primary outcomes:
measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS)
timeFrame: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion
measure: Perceptual body image dissatisfaction on the Photographic Figure Rating Scale (PFRS)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Secondary outcomes:
measure: Cognitive/affective body image on the Body Image State Scale (BISS)
timeFrame: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion
measure: Body image dissatisfaction on the Somatomap3D
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
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)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
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)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Body image satisfaction on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Body Areas Satisfaction
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Overweight preoccupation on the Multidimensional Body-Self Relations Questionnaire- Appearance Scales (MBSRQ-AS) Overweight preoccupation scale
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Noticing on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Not distracting on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Not worrying on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Attention regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Emotional awareness on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Self-regulation on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Trust on the Multidimensional Assessment of Interoceptive Awareness version 2 (MAIA-2)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Interoceptive attention on the Interoceptive Attention Scale (IATS)
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Cardiac interoceptive accuracy on the Heartbeat Tapping Task
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Cardiac interoceptive intensity on the Heartbeat Tapping Task
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Interoceptive intensity during experimental conditions
timeFrame: Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion
measure: Perceived respiratory interoceptive intensity on the Breath Hold Task
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Body image distortion on the Aperture Task
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
measure: Body image distortion on the String task
timeFrame: Through completion of post-intervention follow-up, within 2 weeks of final intervention
Other outcomes:
Locations:
city: Tulsa
country: United States
facility: Laureate Institute for Brain Research
state: Oklahoma
Study officials:
affiliation: Laureate Institute for Brain Research
name: Emily M Choquette, PhD
role: PRINCIPAL_INVESTIGATOR
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