Cognitive-Behavioral Therapy for Anorexia

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Massachusetts General Hospital

Disqualifiers: BMI, HR, BP, Suicidality, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 23

Duration: 20 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new form of therapy called cognitive-behavioral therapy to determine its effectiveness for adults with anorexia nervosa, an eating disorder marked by extreme weight loss and restricted food intake. The goal is to help participants gain weight and reduce eating disorder symptoms. The therapy consists of 20 weekly sessions, with follow-ups extending up to six months. Individuals diagnosed with anorexia nervosa who receive medical monitoring from a doctor at Massachusetts General Hospital might be suitable candidates. As an unphased trial, this study offers participants the chance to contribute to pioneering research that could lead to new treatment options for anorexia nervosa.

Will I have to stop taking my current medications?

The trial protocol does not specify whether you need to stop taking your current medications. However, you must pause any ongoing psychotherapy to focus on the study's therapy sessions.

What prior data suggests that this cognitive-behavioral therapy is safe for adults with anorexia nervosa?

Research has shown that cognitive-behavioral therapy (CBT) for anorexia nervosa is generally safe for participants. Studies have found that this therapy can help patients adhere to their treatment and reduce dropout rates, supporting individuals in maintaining their recovery.

Recent studies specifically indicate that CBT can help individuals feel more comfortable around food, a crucial step for those with anorexia. While CBT is effective in some ways, the recovery rate for anorexia remains about 30%, which is lower compared to other eating disorders.

Overall, the therapy is well-tolerated, with most people not experiencing negative side effects from the treatment itself. This makes CBT a safe option for those considering participation in such a trial. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN) is unique because it focuses on a structured, short-term approach involving 20 weekly sessions with follow-up check-ins. Unlike traditional treatments for anorexia, which often include longer-term therapy or hospitalization, CBT-20-AN aims to provide focused support within a specific timeframe, making it potentially more accessible and less intimidating for patients. Researchers are excited about this treatment because it could offer faster and more sustainable improvements in eating behaviors and mental health, while also being more adaptable to different patient needs.

What evidence suggests that this therapy might be an effective treatment for anorexia?

Research has shown that cognitive-behavioral therapy (CBT) effectively treats anorexia nervosa. Studies have found that CBT helps patients adhere to their treatment plans and reduces dropout rates. Patients receiving CBT tend to achieve better outcomes than those on waitlists. In one study, 44% of patients who underwent CBT showed significant improvement, compared to only 7% who received nutritional counseling. Early findings suggest that CBT can effectively help patients gain weight and reduce symptoms of eating disorders. In this trial, participants will undergo the Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN), which includes 20 weekly sessions and follow-ups at one month, three months, and six months. ^{2 6 7 8 9}

Are You a Good Fit for This Trial?

Adults aged 18 and over with anorexia nervosa can join this study. The trial is designed to help them gain weight and reduce eating disorder behaviors. Participants must be able to attend twenty therapy sessions.

Inclusion Criteria

I am older than 18 years.

Eligible patients must meet DSM-5 criteria for anorexia nervosa. This diagnosis can be conferred via the EDE 17.0D.

Patients must be able to provide informed consent and comply with the study procedures.

Exclusion Criteria

Homicidal ideation

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo twenty weekly sessions of cognitive-behavioral therapy

20 weeks

20 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

3 visits (in-person) at one, three, and six months

What Are the Treatments Tested in This Trial?

Interventions

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

Trial Overview The trial tests a new twenty-session cognitive-behavioral therapy (CBT-20-AN) specifically for adults with anorexia nervosa, aiming to see if it helps patients gain weight and improve their relationship with food.

How Is the Trial Designed?

Group I: CBT-20-AN Experimental Treatment 1 Intervention

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.

Who Is Running the Clinical Trial?

Massachusetts General Hospital

Lead Sponsor

Trials

3,066

Recruited

13,430,000+

Published Research Related to This Trial

Cognitive Behavioral Therapy (CBT) is the first-line treatment for bulimia nervosa and binge-eating disorder, and an enhanced version (CBT-E) is particularly effective for patients with severe comorbid conditions.

While CBT-E shows promise for treating adolescent anorexia nervosa, it is not more effective than standard specialist care for adults with persistent anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavior Therapy for the Eating Disorders. Agras, WS.[2020]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/26689208/

Cognitive Behavioral Therapy for Anorexia Nervosa Cognitive behavioral therapy (CBT) for anorexia nervosa (AN), based on Beck's cognitive theory, was developed in a "generic" form in the early eighties.

2. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0272735813001566

Cognitive Behavioural Therapy for anorexia nervosa The evidence reviewed suggested that CBT demonstrated effectiveness as a means of improving treatment adherence and minimising dropout amongst patients with AN.

3. tandfonline.com tandfonline.com/doi/full/10.1080/16506073.2025.2465745?af=R

Cognitive-behavioural therapy (CBT) for outpatients with ... Overall, results suggest an optimistic picture for patients with anorexia nervosa treated with outpatient CBT. Clinicians can expect good outcomes using CBT, ...

4. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40810212/

The Efficacy of Individual Cognitive Behavioral Therapy for ... Results: CBT was more efficacious with regard to all relevant outcomes than waitlist conditions. For anorexia nervosa, there were no studies ...

5. uptodate.com uptodate.com/contents/anorexia-nervosa-in-adults-cognitive-behavioral-therapy-cbt/abstract/8,11,21

Cognitive-behavioral therapy (CBT)' - UpToDate The criteria for "good outcome" were met by significantly more of the patients receiving cognitive behavior therapy (44%) than nutritional counseling (7%).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11211111/

Recent Advances in Cognitive-Behavioural Therapy for Eating ... Recent research in anorexia nervosa has shown that this element of CBT-ED is associated with rapid learning of safety relating to food, ...

7. tandfonline.com tandfonline.com/doi/full/10.1080/10640266.2024.2421057

Absolute and relative outcomes of cognitive behavior ... The absolute abstinence rate was 0.36 (95% CI: 0.31; 0.43) for CBT and 0.10 (95% CI: 0.08; 0.12) in controls. CBT is probably effective in the ...

8. jeatdisord.biomedcentral.com jeatdisord.biomedcentral.com/articles/10.1186/s40337-022-00536-7

Journal of Eating Disorders | Full Text The effect of cognitive therapy is weaker in patients with AN (only approximately 30% recovery rate) compared to non-underweight eating disorder ...

9. mdpi.com mdpi.com/2072-6643/17/17/2731

Enhanced Cognitive Behavioral Therapy for Young ... Based on intent-to-treat analysis, 94.1% achieved a “good BMI outcome” and 73.5% met criteria for “full response” at EOIT. At follow-up, 64.7% maintained a good ...