Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)
Enrolling by invitation · Not applicable
Conditions studied: Anorexia Nervosa, Atypical Anorexia Nervosa
In brief
The study is a clinical trial assessing the efficacy of a new twenty session cognitive behavioral therapy for adults (18+) with anorexia nervosa (AN) and atypical anorexia nervosa. It is expected that participants will gain a significant amount of weight and experience a significant decrease in eating disorder psychopathology and behavior from pre- to post- treatment and that this will be retained after 6-months.
Key facts
- Study ID
- NCT06597305
- Run by
- Massachusetts General Hospital
- People needed
- 40
- Starts
- 2024-04-22
- Expected to finish
- 2029-05-31
- Last updated by the study team
- 2026-07-29
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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.
You may not qualify if…
- Patients will be excluded if they exhibit:
- BMI < 15, 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
Where it is running
- Eating Disorders Clinical and Research Program — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.