Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 3:16 AM
Ignite Modification Date:
2025-12-25 @ 3:16 AM
NCT ID:
NCT06597305
Eligibility Criteria:
Inclusion Criteria:
1. Eligible patients must meet DSM-5 criteria for anorexia nervosa. This diagnosis can be conferred via the EDE 17.0D.
2. Age \> 18
3. Patients must be able to provide informed consent and comply with the study procedures.
4. Patients must be able to complete computer-based self-report questionnaires with adequate accommodation, if necessary.
5. Patients must have a primary care physician, Adolescent Medicine physician, or consulting physician with eating disorder expertise at Massachusetts General Hospital/Massachusetts General Brigham network who can provide ongoing medical monitoring while the patient takes part in the study.
Exclusion Criteria:
Patients will be excluded if they exhibit:
1. BMI \< 15 or \> 19, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
2. HR \<55 or \>100, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
3. Systolic BP (SBP and DBP) \<80 or \>160, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
4. Temperature \< 96.5 F, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
5. Not eating food by mouth and/or any tube feeding, per EDE
6. Purging \> 4x/week, per EDE.
7. Active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required
8. Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed)
9. Psychosis
10. Intellectual disability
11. Any condition that, after the baseline evaluation, is determined to preclude treatment with CBT.
12. Concurrent psychotherapy. Patients must be willing to take a pause from any ongoing psychotherapy in order to focus on CBT-AN-20, which is in alignment with standard clinical care.
13. Symptoms that are not appropriate for outpatient level of care and therefore require a higher level of care (i.e. BMI \<15 or purging more than 4x/week)
14. Homicidal ideation
15. Inability to speak English well enough to engage in CBT
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06597305
Study Brief:
Protocol Section:
NCT06597305