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

20 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

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 data supports the effectiveness of the treatment Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN)?

Research shows that cognitive-behavioral therapy (CBT) can be effective for treating anorexia nervosa, with studies indicating improvements in weight and eating disorder symptoms. Enhanced CBT (CBT-E), a similar approach, has shown promising results in increasing weight and improving eating disorder features in patients with anorexia nervosa. ^{1 2 3 4 5}

Is Cognitive-Behavioral Therapy for Anorexia safe for humans?

The studies on Enhanced Cognitive Behavioral Therapy (CBT-E) for anorexia nervosa suggest it is generally safe, as it has been used successfully in both adults and adolescents without significant safety concerns reported. It has been shown to help with weight gain and reduce eating disorder symptoms, indicating it is a viable treatment option. ^{2 6 7 8 9}

How is the treatment Twenty Session Cognitive-Behavioral Therapy for Anorexia Nervosa (CBT-20-AN) different from other treatments for anorexia?

CBT-20-AN is a specific form of cognitive-behavioral therapy designed to address not only the eating disorder symptoms but also related issues like mood intolerance, perfectionism, low self-esteem, and interpersonal difficulties. This makes it more comprehensive compared to standard CBT, which may focus primarily on eating behaviors. ^{10 11 12 13 14}

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive-behavioral therapy for threshold and subthreshold anorexia nervosa: a three-year follow-up study. [2019]

2. England pubmed.ncbi.nlm.nih.gov

Enhanced cognitive behaviour therapy for adults with anorexia nervosa: a UK-Italy study. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Pathways to Recovery: development and evaluation of a cognitive-behavioural therapy in-patient treatment programme for adults with anorexia nervosa. [2020]

4. Switzerland pubmed.ncbi.nlm.nih.gov

Treatment of anorexia nervosa by the integration of behavior therapy and psychotherapy. [2018]

5. United States pubmed.ncbi.nlm.nih.gov

Assessing the distinctiveness of psychotherapies and examining change over treatment for anorexia nervosa with cognitive-behavior therapy, interpersonal psychotherapy, and specialist supportive clinical management. [2022]

6. Switzerland pubmed.ncbi.nlm.nih.gov

Psychotherapeutic Treatment for Anorexia Nervosa: A Systematic Review and Network Meta-Analysis. [2020]

7. England pubmed.ncbi.nlm.nih.gov

A multi-center, randomized, parallel-group study to compare the efficacy of enhanced cognitive behavior therapy (CBT-E) with treatment as usual (TAU) for anorexia nervosa: study protocol. [2023]

8. England pubmed.ncbi.nlm.nih.gov

Experiences when implementing enhanced cognitive behavioral therapy as a standard treatment for anorexia nervosa in outpatients at a public specialized eating-disorder treatment unit. [2022]

9. England pubmed.ncbi.nlm.nih.gov

Enhanced cognitive behaviour therapy for adolescents with anorexia nervosa: an alternative to family therapy? [2022]

10. Switzerland pubmed.ncbi.nlm.nih.gov

Inpatient cognitive behaviour therapy for anorexia nervosa: a randomized controlled trial. [2022]

11. United States pubmed.ncbi.nlm.nih.gov

Basic principles for applying cognitive-behavioral therapy to anorexia nervosa. [2019]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Cognitive Behavioural Therapy for an Adolescent with Anorexia Nervosa. [2022]

13. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavior Therapy for the Eating Disorders. [2020]

14. United States pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for Anorexia Nervosa: An Update. [2021]