Status:
ENROLLING_BY_INVITATION
Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)
Lead Sponsor:
Massachusetts General Hospital
Conditions:
Anorexia Nervosa
Eligibility:
All Genders
18+ years
Phase:
NA
Brief Summary
The study is a clinical trial assessing the efficacy of a new twenty session cognitive behavioral therapy for adults (18+) with anorexia nervosa (AN). It is expected that participants will gain a sign...
Eligibility Criteria
Inclusion
- Eligible patients must meet DSM-5 criteria for anorexia nervosa. This diagnosis can be conferred via the EDE 17.0D.
- Age \> 18
- Patients must be able to provide informed consent and comply with the study procedures.
- Patients must be able to complete computer-based self-report questionnaires with adequate accommodation, if necessary.
- 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
- Patients will be excluded if they exhibit:
- BMI \< 15 or \> 19, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
- HR \<55 or \>100, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
- Systolic BP (SBP and DBP) \<80 or \>160, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
- Temperature \< 96.5 F, obtained via patient medical chart or from study 2023P000469 or 2018P002915.
- Not eating food by mouth and/or any tube feeding, per EDE
- Purging \> 4x/week, per EDE.
- Active suicidality (suicidal ideation with intent or plan) to the point that more intensive treatment (i.e. acute hospitalization) is required
- Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed)
- Psychosis
- Intellectual disability
- Any condition that, after the baseline evaluation, is determined to preclude treatment with CBT.
- 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.
- 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)
- Homicidal ideation
- Inability to speak English well enough to engage in CBT
Key Trial Info
Start Date :
April 22 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 1 2026
Estimated Enrollment :
20 Patients enrolled
Trial Details
Trial ID
NCT06597305
Start Date
April 22 2024
End Date
May 1 2026
Last Update
April 17 2025
Active Locations (1)
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1
Eating Disorders Clinical and Research Program
Boston, Massachusetts, United States, 02114