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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial examines the effectiveness of Cognitive Behavioral Therapy (CBT) for treating eating disorders such as Bulimia Nervosa (BN) and Binge Eating Disorder (BED) in veterans. It compares two methods: one involves a clinician over video calls (teleCBT), and the other uses self-guided materials (shCBT) at home. The trial aims to improve treatment access and outcomes for veterans through new telehealth technology. Veterans who use the Veteran Health Administration and have BN or BED might be suitable candidates. As an unphased trial, this study allows veterans to contribute to innovative telehealth solutions that could enhance treatment accessibility and effectiveness.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that Cognitive Behavioral Therapy (CBT), whether online or as a self-help program, is generally safe and well-received by participants. One study found that online CBT for bulimia nervosa (BN) was as acceptable to participants as in-person therapy, indicating both are safe and well-tolerated. Another study demonstrated that online, guided self-help CBT for binge-eating disorder (BED) was effective and safe, with results similar to traditional therapy.

For the self-help version of CBT, research indicates it is a useful and safe option for managing eating disorders. This method allows participants to work through the materials independently, making it user-friendly and easy to handle.

Overall, both online and self-help CBT methods are supported by evidence showing they are effective and safe for treating eating disorders like BN and BED. Participants generally handle these therapies well, with no major safety issues reported in the studies. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments for binge eating disorders because they offer innovative ways to deliver Cognitive Behavioral Therapy (CBT). Telehealth CBT (teleCBT) allows therapy to be conducted virtually, making it more accessible for people who can't attend in-person sessions. Meanwhile, Self-Help CBT (shCBT) empowers participants to guide themselves through therapy with the same materials, providing flexibility and autonomy. These approaches could greatly enhance access to effective treatment, allowing more people to receive help in a way that fits their lifestyle.

What evidence suggests that this trial's treatments could be effective for eating disorders?

Studies have shown that Cognitive Behavioral Therapy (CBT) can help treat eating disorders like binge eating disorder (BED) and bulimia nervosa (BN). In this trial, participants will be randomly assigned to one of two treatment arms. One arm will receive CBT delivered through telehealth (teleCBT), which research indicates can greatly improve symptoms and make treatment more accessible. Specifically, one study found that by 40 weeks, nearly half of the participants had significant symptom reduction. The other arm will receive Self-Help CBT (shCBT), which controlled studies have shown can effectively reduce binge eating episodes. Evidence suggests that both telehealth and self-help versions of CBT can lead to meaningful improvements in eating disorder symptoms. ^{1 4 6 7 8}

Who Is on the Research Team?

Robin Masheb, PhD

Principal Investigator

VA Connecticut Research Department

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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 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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. nationaleatingdisorders.org nationaleatingdisorders.org/

NEDA | Eating Disorders Support, Awareness & Recovery Access support, explore resources, join community events, and take a free eating disorders screening—start your recovery journey with NEDA!

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC2928448/

Cognitive Behavioral Therapy for Eating Disorders - PMC Cognitive behavioral therapy (CBT) is the leading evidence-based treatment for bulimia nervosa. A new “enhanced” version of the treatment appears to be more ...

3. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2818753

Web-Based Cognitive Behavioral Self-Help Intervention for ... In this randomized clinical trial involving 154 patients with BED, access to a web-based cognitive behavioral self-help intervention was superior to a waiting- ...

4. jmir.org jmir.org/2023/1/e40472/

Efficacy of Web-Based, Guided Self-help Cognitive ... Efficacy of Web-Based, Guided Self-help Cognitive Behavioral Therapy–Enhanced for Binge Eating Disorder: Randomized Controlled Trial

5. sciencedirect.com sciencedirect.com/science/article/abs/pii/S027273581200030X

Cognitive–behavioral guided self-help for eating disorders Controlled studies have shown that CBTgsh can be an effective treatment for binge eating disorder and bulimia nervosa, although it is contraindicated for ...

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10186189/

Efficacy of Web-Based, Guided Self-help Cognitive Behavioral ... Owing to the gap between treatment supply and demand, there are long waiting periods for patients with binge eating disorder, and there is an urgent need to ...

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

Absolute and relative outcomes of cognitive behavior ... We confirmed that cognitive–behavioral therapy is probably effective in the treatment of bulimia nervosa and binge eating disorder.

8. frontiersin.org frontiersin.org/journals/psychiatry/articles/10.3389/fpsyt.2024.1332360/full

Web-based guided self-help cognitive behavioral therapy– ... Binge-eating disorder (BED) is a psychiatric disorder characterized by recurrent episodes of eating a large amount of food in a discrete period of time ...