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New treatment option for Anorexia Nervosa
Official title Interoceptive Mechanisms of Body Image Disturbance in Anorexia Nervosa
ClinicalTrials.gov ID: NCT06332963
What this study is testing
- What it's testing
- 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).
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 13 to 50, women only
You may be able to join if
- 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
You likely can't join if
- 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
- Orthostatic hypotension as determined by medical provider, evidenced in chart (defined as a drop of ≥ 20 mmHg in systolic blood pressure (BP) or a...
- Seizure reported within the previous 12 months
See the full eligibility criteria
- 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).
- 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
- Orthostatic hypotension as determined by medical provider, evidenced in chart (defined as a drop of ≥ 20 mmHg in systolic blood pressure (BP) or a drop of ≥ 10 mm Hg in diastolic blood pressure (BP) when measured...
- Seizure reported within the previous 12 months
- Co-morbid diagnoses of Diagnostic and Statistical Manual of Mental Disorders, 5th ed. (DSM-5) bipolar disorder, schizophrenia, or other psychosis spectrum disorder
- Systolic blood pressure \> 160 mmHg
- Diastolic blood pressure \>100 mmHg
- Resting heart rate \<50 beats per minute.
The study team makes the final eligibility decision.
Where it's taking place
- Tulsa, Oklahoma, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 13 years to 50 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tulsa, Oklahoma, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.