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Enrolling by invitationNo phase
Evaluation of a Twenty-session Cognitive-behavioral Therapy With Anorexia Nervosa (CBT-20-AN) Among Adults (18+)
Key facts
- Who runs it
- Massachusetts General Hospital
- Where
- Boston, United StatesSee the site
- Trial code
- Status
- Enrolling by invitation
- People taking part
- 40 people, planned
- Started
- 22 Apr 2024
- Expected to end
- 31 May 2029
- Type of study
- Interventional
- Treatments tested
- Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)
- Record updated
- 29 July 2026
Who can take part
- Age
- 18 years and older
- Sex
- Women and men
- Healthy volunteers
- Cannot take part
The registry criteria, word for word
Show all 21 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
- Active untreated and unstable bipolar disorder (i.e. stable bipolar disorder under care of a psychiatrist is allowed)
- 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
- Psychosis
- Intellectual disability
- 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 in United States
- Eating Disorders Clinical and Research ProgramBoston, United StatesEnrolling by invitation
About the trial
What the trial wants to find out
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.
The group in the trial
- CBT-20-ANTreatment being tested
The single CBT-20-AN arm of this study is experimental, consisting of 20 weekly sessions and one-month, three-month, and six-month follow-ups.
Treatment: Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Twenty-session Cognitive-behavioral Therapy for Adults With Anorexia Nervosa (CBT-20-AN)
- Record updated
- 29 July 2026