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Search / Trial NCT06597305

Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)

Launched by MASSACHUSETTS GENERAL HOSPITAL · Sep 12, 2024

Trial Information

Current as of June 26, 2025

Enrolling by invitation

Keywords

ClinConnect Summary

No description provided

Gender

ALL

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

About Massachusetts General Hospital

Massachusetts General Hospital (MGH) is a leading academic medical center located in Boston, Massachusetts, renowned for its commitment to advancing medical research and patient care. As a prominent teaching hospital affiliated with Harvard Medical School, MGH plays a pivotal role in clinical trials across a wide range of disciplines, including cardiology, oncology, neurology, and more. The institution is dedicated to fostering innovative research that translates into effective therapies and improved health outcomes. MGH's Clinical Trials Office provides comprehensive support to facilitate the design, implementation, and management of clinical studies, ensuring adherence to the highest ethical standards and regulatory compliance. With a focus on collaboration and patient-centered care, MGH strives to enhance medical knowledge and contribute to the future of healthcare.

Locations

Boston, Massachusetts, United States

Patients applied

0 patients applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported