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

NCT ID: NCT06597305

Last Updated: 2025-04-17

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-22
• Study Completion Date: 2026-05-31

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 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.

Conditions

Anorexia Nervosa

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

CBT-20-AN

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.

Group Type: EXPERIMENTAL

Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)

Intervention Type: BEHAVIORAL

Twenty session cognitive behavioral therapy for Anorexia Nervosa (CBT-20-AN) is an treatment for Anorexia Nervosa delivered by a mental health clinician. This treatment (CBT-20-AN) lasts just 20 sessions and has been designed to allow individuals with AN to reap the benefits of CBT for eating disorders (up to 40 sessions) in less time, increasing access to care and shortening time to symptom reduction.

Interventions

Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)

Twenty session cognitive behavioral therapy for Anorexia Nervosa (CBT-20-AN) is an treatment for Anorexia Nervosa delivered by a mental health clinician. This treatment (CBT-20-AN) lasts just 20 sessions and has been designed to allow individuals with AN to reap the benefits of CBT for eating disorders (up to 40 sessions) in less time, increasing access to care and shortening time to symptom reduction.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Massachusetts General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Kendra R. Becker, Ph.D.

Eating Disorder Clinical and Research Program (EDCRP) Director of Translational Research/Associate Professor of Psychiatry

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Eating Disorders Clinical and Research Program

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

2023P002713

Identifier Type: -

Identifier Source: org_study_id