What side effects are associated with this type of intervention?

Common treatments for Binge Eating Disorder, such as guided self-help interventions based on cognitive-behavioral therapy (CBT), generally have minimal physical side effects. However, patients may experience emotional or psychological side effects, such as increased anxiety or distress, especially when confronting and changing long-standing behaviors and thoughts related to eating. Additionally, some individuals may feel overwhelmed or frustrated by the self-monitoring and homework assignments required by CBT. It is important for patients to communicate with their healthcare providers to manage these potential side effects effectively.

What prior FDA approvals exist?

The FDA has approved the use of lisdexamfetamine dimesylate (Vyvanse) for the treatment of Binge Eating Disorder (BED). This medication is a stimulant that helps reduce binge eating episodes. While Vyvanse does not directly align with the structured guidance and support model of the guided self-help intervention, it represents a pharmacological approach to managing BED. The guided self-help intervention, on the other hand, focuses on providing structured support through a self-help book and telephone guidance, aiming to improve psychological and social functioning without medication.

What other types of research exist?

Promising novel alternatives to Guided Self-Help Intervention for Binge Eating Disorder patients include: 1) Cognitive-Behavioral Therapy (CBT), which has shown effectiveness in treating various eating disorders; 2) Family Therapy, which can be beneficial, especially for adolescents; and 3) Technology-enhanced interventions, such as online CBT programs and smartphone applications, which offer accessibility and structured support.

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Behavioral Intervention

Guided Self-Help CBT for Binge Eating Disorder

Q: What is the mechanism of action of this treatment?

The most common treatments for Binge Eating Disorder (BED) include cognitive-behavioral therapy (CBT) and pharmacotherapy. CBT focuses on changing dysfunctional thoughts and behaviors related to eating, helping patients develop healthier eating patterns and coping mechanisms. Pharmacotherapy, especially with selective serotonin reuptake inhibitors (SSRIs), alters brain chemistry to reduce binge eating episodes and improve mood. These treatments are important for BED patients as they address both psychological and physiological aspects of the disorder, potentially leading to significant improvements in quality of life.

N/A

Recruiting

Research Sponsored by Yale University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 and over

Be older than 18 years old

Must not have

Receiving treatment for co-existing psychiatric condition (e.g., bipolar disorder, psychotic illness, drug or alcohol dependence

Timeline

Screening 3 weeks

Treatment Varies

Follow Up week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a self-help program for people with binge eating who can't see a doctor. It uses a book for guidance and phone calls from volunteers for support. The goal is to see if this method can help improve their eating habits and quality of life.

Who is the study for?

This trial is for adults over 18 who have contacted the National Eating Disorder Association about binge eating or disordered overeating. They must be able to speak, read, and understand English and consent to guided self-help plus study assessments. It's not for those pregnant, breastfeeding, underweight (BMI <20), currently in treatment for an eating disorder or a serious psychiatric condition like bipolar disorder or drug dependence.

What is being tested?

The trial tests a guided self-help intervention using a self-help book with telephone support from trained volunteers. The aim is to see if this approach can help people unable to access professional treatments for binge eating disorders by improving their quality of life and psychological functioning.

What are the potential side effects?

Since the intervention involves cognitive behavioral therapy via guided self-help without medication, there are no direct physical side effects expected. However, participants may experience emotional discomfort addressing their eating behaviors.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I am currently being treated for a mental health condition.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and week 0 (baseline) and week 64 (48 weeks/1 year after end of intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Feasibility of providing intervention-completion Participants' ratings of satisfaction with the intervention

Feasibility of providing intervention-consent

Ratings of Acceptability of intervention to participants

+2 more

Secondary study objectives

Likely effectiveness - depression

Likely effectiveness - impairment due to eating difficulties

Likely effectiveness -Eating difficulties

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Self-help CBTExperimental Treatment1 Intervention

Evidence based book detailing self-help program to follow plus Telephone support from a non specialist guide

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for Binge Eating Disorder (BED) include cognitive-behavioral therapy (CBT) and pharmacotherapy. CBT focuses on changing dysfunctional thoughts and behaviors related to eating, helping patients develop healthier eating patterns and coping mechanisms. Pharmacotherapy, especially with selective serotonin reuptake inhibitors (SSRIs), alters brain chemistry to reduce binge eating episodes and improve mood. These treatments are important for BED patients as they address both psychological and physiological aspects of the disorder, potentially leading to significant improvements in quality of life.

Guided self-help of bulimia nervosa in a specialist setting: a pilot study.A qualitative review of psychosocial treatments for bulimia.