Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa

Status: Recruiting
Location: See location...
Intervention Type: Behavioral
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 13
Maximum Age: 50
Healthy Volunteers: f
View:

• 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

• No current evidence of orthostatic hypotension or if there is no evidence of additional fall risk as determined by their provider

• Clinical status transition from acute to residential status

• No new psychiatric medications in the week prior to randomization

• Female sex assigned at birth

• Ages 13 to 50 years

⁃ Independently ambulatory

⁃ Ability to lay flat comfortably

⁃ English proficiency

⁃ Willingness and ability to participate in study procedures

⁃ Provision of informed consent (parent consent and minor assent if less than 18 years of age).

Locations
United States
Oklahoma
Laureate Institute for Brain Research
RECRUITING
Tulsa
Contact Information
Primary
Emily M Choquette, PhD
echoquette@laureateinstitute.org
918-703-2343
Time Frame
Start Date: 2024-04-19
Estimated Completion Date: 2028-12
Participants
Target number of participants: 102
Treatments
Experimental: Interoceptively Focused Treatment (IFT)
The IFT intervention will guide participants through a tailored application of present-moment focus toward experiencing awareness and acceptance of bodily signals and defusing thoughts related to those signals. For example, participants will engage in several exercises to increase awareness of body sensations, thoughts, and emotions. IFT consists of one introduction session with a clinician (\~60 minutes) the introduction session was designed as a brief introduction to acceptance- and mindfulness-based concepts with guided practice exercises and closing time for participants to briefly process challenges to execution of exercises and the experience during the session. This is followed by three IFT sessions which combine acceptance- and mindfulness-based skills practice with floatation-REST (Reduced Environmental Stimulation Therapy via floatation).
Active_comparator: Exteroceptively Focused Treatment (EFT)
In the EFT condition, exercises are tailored toward experience of the present moment via external environment mindfulness (i.e., attending to experience) and defusion of thoughts. EFT consists of one introduction session with a clinician (\~60 minutes) the introduction session, similar in format to IFT, introduces acceptance- and mindfulness-based concepts. This is followed by three EFT sessions during which participants engage in brief guided skills training followed by video guided skills practice. The EFT condition is designed to increase awareness of the present moment and experience of the environment and view thoughts or emotions that may impact engagement with the current moment in a nonjudgmental way.
Related Therapeutic Areas
Sponsors
Leads: Laureate Institute for Brain Research, Inc.

This content was sourced from clinicaltrials.gov