Cognitive Behavioral Therapy for Eating Disorders

(EASED Trial)

Overseen By Robin M Masheb, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: VA Connecticut Healthcare System

Disqualifiers: Active psychosis, High suicide risk, Pregnancy, others

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

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 11

Duration: 12 weeks

144 Participants Needed

Trial Summary

What is the purpose of this trial?

When untreated, eating disorders present with tremendous burdens to affected active duty Service members and Veterans and their families, and are very costly to the DoD and VA healthcare system. A comparative effectiveness study with state-of-the-art virtual treatment for BN and BED specifically adapted for testing with the Veteran population and other underrepresented eating disorder populations will lead to major improvements in clinical outcomes. The treatment will be integrated with VA's newest telehealth technology to profoundly enhance access to care anywhere, at any time. This trial of therapist-led and self-help CBT treatments, combined with our expert panel methods to inform VA Clinical Practice Guidelines for Eating Disorders and plans for dissemination, will accelerate the pace for the transition of results both for large-scale deployment in the VA system and for real-world impact among diverse and underrepresented eating disorder populations.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your healthcare provider.

What data supports the effectiveness of the treatment Cognitive Behavioral Therapy (CBT) for eating disorders?

Research shows that Cognitive Behavioral Therapy (CBT) is more effective than other treatments for bulimia nervosa and binge eating disorder. However, its effectiveness for anorexia nervosa in adults is not well-supported, and evidence for adolescents is limited. ^{1 2 3 4 5}

Is Cognitive Behavioral Therapy (CBT) safe for treating eating disorders?

Cognitive Behavioral Therapy (CBT) has been widely studied and is generally considered safe for treating eating disorders, with no significant safety concerns reported in the research. ^{5 6 7 8 9}

How is Cognitive Behavioral Therapy (CBT) unique for treating eating disorders?

Cognitive Behavioral Therapy (CBT) is unique for treating eating disorders because it is an evidence-based treatment specifically effective for bulimia nervosa and binge-eating disorder, and its enhanced version (CBT-E) is suitable for all eating disorders, including anorexia nervosa. CBT-E focuses on both the core issues and additional factors that maintain the disorder, making it a comprehensive approach. ^{2 5 9 10 11}

Research Team

Robin Masheb, PhD

Principal Investigator

VA Connecticut Research Department

Eligibility Criteria

This trial is for adults over 18 who are part of the Veteran Health Administration and have been diagnosed with Bulimia Nervosa or Binge Eating Disorder. It's not for those with Anorexia, pregnant or nursing individuals, or anyone with medical/psychiatric conditions that could hinder participation.

Inclusion Criteria

Veteran Health Administration (VHA) user

I have been diagnosed with Bulimia Nervosa or Binge Eating Disorder.

Exclusion Criteria

I do not have anorexia or atypical anorexia.

Pregnancy or lactation

Medical or psychiatric illness, or cognitive deficits, that interfere with providing consent, completing assessments, or engaging in treatment for eating disorders

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either TeleCBT or shCBT for binge eating disorders over a three-month period

12 weeks

8 to 10 sessions (virtual) for TeleCBT; self-guided for shCBT

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 months

Assessments at 3 and 6 months post-treatment

Treatment Details

Interventions

• Cognitive Behavioral Therapy (CBT)

Trial Overview The study tests Cognitive Behavioral Therapy (CBT) delivered virtually to treat eating disorders in veterans and underrepresented groups. The goal is to integrate this treatment into VA telehealth services and improve clinical outcomes.

Participant Groups

Group I: Telehealth Cognitive Behavioral Therapy (teleCBT) Experimental Treatment 1 Intervention

About one-half of participants will be randomly assigned to Telehealth Cognitive Behavioral Therapy (teleCBT), a virtual Cognitive Behavioral Therapy (CBT) for binge eating disorders delivered via an Office of Information and Technology (OI\&T)-approved video platform, by a master's-level research clinician. TeleCBT will be administered in 8 to 10 hourly individual sessions over a three-month treatment period.

Group II: Self-Help Cognitive Behavioral Therapy (shCBT) Active Control 1 Intervention

About one-half of participants will be randomly assigned to Self-Help Cognitive Behavioral Therapy (shCBT), a Self-Help CBT for binge eating disorders initiated by a research assistant via telephone and then continued by the participant at home. These materials are the same exact ones provided to participants in TeleCBT (i.e., treatments are matched for materials), and will be mailed to participants. They will be instructed to work independently through one chapter per week for the following 12 weeks (i.e., treatment length is matched to TeleCBT).

Cognitive Behavioral Therapy (CBT) is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in European Union as Cognitive Behavioural Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Approved in Canada as Cognitive Behavioral Therapy for:

• Chronic pain
• Anxiety disorders
• Depressive disorders
• Trauma-related disorders

Who Is Running the Clinical Trial?

VA Connecticut Healthcare System

Lead Sponsor

Trials

86

Recruited

8,800+

United States Department of Defense

Collaborator

Trials

940

Recruited

339,000+

Findings from Research

Cognitive Behavioral Therapy Enhanced (CBT-E) was found to be an effective treatment for adults with various eating disorders, showing significant improvements in both eating disorder symptoms and general mental health after treatment and at a 20-week follow-up, based on a study of 114 adult females.

However, the study noted a high dropout rate of 50% among participants, indicating that addressing psychosocial and environmental issues is crucial to improve treatment completion rates in clinical settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Effectiveness of Enhanced Cognitive Behavioural Therapy (CBT-E): A Naturalistic Study within an Out-Patient Eating Disorder Service. Signorini, R., Sheffield, J., Rhodes, N., et al.[2022]

High-intensity one-to-one cognitive-behavioral therapy (CBT) is more effective in the short term for treating eating disorders like binge eating disorder (BED) and bulimia nervosa (BN) compared to other active interventions, based on a systematic review of 44 studies.

There is limited evidence supporting the effectiveness of group CBT or low-intensity CBT against other treatments, and significant gaps exist in understanding the long-term effects and applicability of CBT across different demographics and eating disorder types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for eating disorders: A map of the systematic review evidence base. Kaidesoja, M., Cooper, Z., Fordham, B.[2023]

Cognitive behavioral therapy for eating disorders (CBT-ED) is shown to be more effective than other treatments for bulimia nervosa (BN) and binge eating disorder (BED), while interpersonal psychotherapy is equally effective for BED.

Current evidence does not support the effectiveness of CBT-ED for adult anorexia nervosa (AN) and is lacking for adolescents, indicating a need for further research in these areas.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behavioral Therapy for the Eating Disorders. Agras, WS., Bohon, C.[2022]

In a study of 65 adult women with eating disorders, those who completed integrated group cognitive-behavioral therapy (CBT) showed significant improvements in eating attitudes, mood, coping skills, and self-esteem after 10 sessions.

After a 10-year follow-up, patients who completed the group CBT had a better prognosis compared to those who dropped out, highlighting the long-term benefits of completing group therapy in developing social skills and self-awareness.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 10-year follow-up study of completers versus dropouts following treatment with an integrated cognitive-behavioral group therapy for eating disorders. Okamoto, Y., Miyake, Y., Nagasawa, I., et al.[2022]

In a study involving 272 adults with bulimia and atypical eating disorders, Enhanced Cognitive Behaviour Therapy (CBT-E) led to significant improvements in eating disorder symptoms and associated psychological issues, particularly for those who completed the treatment.

The study found a 40.8% attrition rate, with non-completers experiencing higher levels of anxiety, suggesting that addressing anxiety may be crucial for improving treatment retention and outcomes.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive Behaviour Therapy for Bulimia Nervosa and Eating Disorders Not Otherwise Specified: Translation from Randomized Controlled Trial to a Clinical Setting. Knott, S., Woodward, D., Hoefkens, A., et al.[2022]

Cognitive Behavioral Therapy for Eating Disorders (CBT-T) was effective for 40 adults with bulimia or atypical anorexia, showing large effect sizes and significant rates of abstinence from binge eating (30.1%) and purging (73.1%) after treatment.

The study found no correlation between the duration of the eating disorder and the effectiveness of CBT-T, suggesting that this treatment can be beneficial regardless of how long the disorder has persisted.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A case series of CBT-T in routine clinical practice. Rose, C., Bakopoulou, I., Novak, T.[2021]

In a randomized controlled trial with 143 adult patients, enhanced cognitive behavior therapy (CBT-E) showed a significantly higher recovery rate from eating disorders (57.7%) at 20 weeks compared to treatment as usual (TAU) (36.0%).

CBT-E was found to be more effective in improving self-esteem and was less intensive and shorter than TAU, suggesting that its broader implementation could enhance treatment efficiency and accessibility for eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial. de Jong, M., Spinhoven, P., Korrelboom, K., et al.[2021]

A 10-session version of cognitive behavior therapy for eating disorders (CBT-T) was effective for nonunderweight cases, showing positive outcomes comparable to longer forms of CBT, despite being delivered by clinical assistants rather than specialists.

The therapy was well-received, with good retention rates and positive changes in symptoms, suggesting that CBT-T could improve access to treatment for eating disorders in various healthcare settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A 10-session cognitive-behavioral therapy (CBT-T) for eating disorders: Outcomes from a case series of nonunderweight adult patients. Waller, G., Tatham, M., Turner, H., et al.[2019]

Cognitive-behavioral therapy for eating disorders (CBT-ED) has evolved significantly over the past five years, reinforcing its effectiveness and expanding its application to new disorders like Avoidant/Restrictive Food Intake Disorder (ARFID).

Recent adaptations in CBT-ED delivery, particularly during the COVID-19 pandemic, have shown promise for remote treatment methods, although challenges remain in achieving better outcomes for conditions like anorexia nervosa.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

New developments in cognitive-behavioural therapy for eating disorders (CBT-ED). Mulkens, S., Waller, G.[2023]

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]

Cognitive behavioral therapy (CBT) is the most effective evidence-based treatment for bulimia nervosa, and an enhanced version of CBT shows even greater effectiveness for various eating disorders.

The enhanced CBT is based on a 'transdiagnostic' theory, making it applicable not only to bulimia nervosa but also to anorexia nervosa and other unspecified eating disorders, broadening its therapeutic reach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Cognitive behavioral therapy for eating disorders. Murphy, R., Straebler, S., Cooper, Z., et al.[2022]

References

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

The Effectiveness of Enhanced Cognitive Behavioural Therapy (CBT-E): A Naturalistic Study within an Out-Patient Eating Disorder Service. [2022]

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

Cognitive behavioral therapy for eating disorders: A map of the systematic review evidence base. [2023]

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

Cognitive Behavioral Therapy for the Eating Disorders. [2022]

4. England pubmed.ncbi.nlm.nih.gov

A 10-year follow-up study of completers versus dropouts following treatment with an integrated cognitive-behavioral group therapy for eating disorders. [2022]

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

Cognitive Behaviour Therapy for Bulimia Nervosa and Eating Disorders Not Otherwise Specified: Translation from Randomized Controlled Trial to a Clinical Setting. [2022]

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

A case series of CBT-T in routine clinical practice. [2021]

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

Effectiveness of enhanced cognitive behavior therapy for eating disorders: A randomized controlled trial. [2021]

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

A 10-session cognitive-behavioral therapy (CBT-T) for eating disorders: Outcomes from a case series of nonunderweight adult patients. [2019]

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

New developments in cognitive-behavioural therapy for eating disorders (CBT-ED). [2023]

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

Cognitive Behavior Therapy for the Eating Disorders. [2020]

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

Cognitive behavioral therapy for eating disorders. [2022]