Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age13-50
SponsorLaureate Institute for Brain Research, Inc.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Primary diagnosis of anorexia nervosa
Photographic Figure Rating Scale (PFRS) body dissatisfaction score greater than or equal to 1
Eating Disorder Examination Questionnaire (EDE-Q6) Shape Concern Subscale score greater than or equal to 3
Weight restored to body mass index (BMI) greater than or equal to 17.5
Disqualifiers
Active suicidal ideation with plan and intent
Active cutting or skin lacerating behaviors
Pregnancy as defined by urine screening
Acute intoxication as indicated by urine drug screen or breathalyzer
Trial design
Design model
Parallel
Treatments tested in this trial
Floatation-REST
BehavioralParticipants lay supine in one of two circular fiberglass pools that were custom-designed for research purposes. The floatation pools are 8 feet in diameter and contain 11 inches of reverse osmosis water saturated with \~1,800 pounds of Epsom salt (magnesium sulfate). This creates a dense saltwater solution with a specific gravity of \~1.26, allowing participants to effortlessly float on their back while the water hovers just above the ears. The temperature of the water and air is calibrated to approximate skin temperature (\~95.0 °F), helping to minimize the need for thermoregulation while reducing the boundary between air, body, and water. Clothing is usually not worn while floating since anything touching the body can generate somatosensory stimulation, detracting from the float experience. However, participants have the option to choose if they would prefer to float with a bathing suit or nude. During floatation-REST, visual, auditory, olfactory stimuli are minimized.
IFT
BehavioralTwo ACT principles, contact with the present moment and cognitive defusion were utilized in the development of the intervention. In the IFT condition, awareness and acceptance of bodily signals, thoughts, and emotions and being present with one's self (i.e., mindfulness focus is inward) are emphasized. All participants will engage in an introduction session. Followed by three IFT sessions. The experimental sessions are formatted the same for both conditions. Each begins with a clinician reviewing previous constructs and introducing a new skill. Then participants engage in their assigned condition intervention, followed by a debrief with a clinician. Practices in both conditions are matched as closely as possible for content. The mindful focus of IFT is internal toward thoughts, emotions, and body sensations. In the experimental sessions, participants will engage in a floatation-REST session while practicing acceptance and mindfulness-based skills presented to them.
EFT
BehavioralTwo acceptance and commitment therapy modules contact with the present moment and cognitive defusion were utilized in the development of the intervention. In the EFT condition, awareness and acceptance of thoughts and emotions and mindfulness of current experience are emphasized. The mindful focus of EFT is external, toward attending to experience as well as thoughts and emotions. During experimental sessions, participants will engage in a self-guided and computer-based practice of acceptance and mindfulness-based skills. These videos were created to ensure content was congruent with the material presented in the introduction sessions and represent skills that build from session to session.
Treatment groups
102 Participants
are divided into 2 treatment groupsGroup A: Interoceptively Focused Treatment (IFT)Experimental treatment 2 interventions
Group B: Exteroceptively Focused Treatment (EFT)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
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)
Time frame
Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion2
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).
Time frame
Through completion of post-intervention follow-up, within 2 weeks of final interventionSecondary outcomes
1
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)
Time frame
Through completion of experimental sessions, 2-4 weeks after pre-treatment baseline completion2
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)
Time frame
Through completion of post-intervention follow-up, within 2 weeks of final intervention3
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
Time frame
Through completion of post-intervention follow-up, within 2 weeks of final intervention4
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).
Time frame
Through completion of post-intervention follow-up, within 2 weeks of final interventionSponsors and contacts
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Source ClinicalTrials.gov