What is the mechanism of action of this treatment?

Neurobiologically-guided intensive family-based treatment for Anorexia Nervosa leverages insights into the brain's role in the disorder and the critical influence of family dynamics. This approach targets the neurobiological underpinnings of Anorexia Nervosa, such as dysregulated reward processing and heightened anxiety responses, by involving family members in the treatment process. Family members are educated about the neurobiological aspects of the disorder and trained to support the patient through structured meal support and emotional regulation strategies. This method is crucial as it addresses both the biological and environmental factors contributing to Anorexia Nervosa, promoting a more holistic and supportive recovery environment.

What side effects are associated with this type of intervention?

Common treatments for Anorexia Nervosa, such as Family-Based Treatment (FBT), Cognitive Behavioral Therapy (CBT), and pharmacotherapy, have varying side effects. FBT, which involves family support, generally has minimal side effects but can be emotionally challenging. CBT may cause initial anxiety or distress as patients address their eating behaviors. Pharmacotherapy, used for comorbid conditions, can lead to gastrointestinal issues, sleep disturbances, and weight gain. Combining these treatments can enhance efficacy but may also increase the likelihood of experiencing side effects.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Anorexia Nervosa. Treatment typically involves a combination of nutritional rehabilitation, psychotherapy, and family-based interventions. Neurobiologically-Guided Intensive Family Based Treatment, which leverages neurobiological insights and family dynamics, represents an innovative approach but is not yet an FDA-approved standard. Current therapeutic strategies focus on addressing the psychological and behavioral aspects of the disorder, often involving family therapy to support recovery.

What other types of research exist?

Promising novel alternatives for Anorexia Nervosa treatment in 2024 include: 1) Transcranial Magnetic Stimulation (TMS), which shows potential in modulating brain activity associated with eating disorders. 2) Mind-body therapies such as yoga and Qigong massage, which have demonstrated improvements in psychological and physical well-being. 3) Digital self-help interventions, including smartphone applications that provide cognitive-behavioral therapy (CBT) principles and support. 4) Pharmacological treatments like lisdexamfetamine and topiramate, which have shown efficacy in reducing symptoms of eating disorders. These alternatives offer diverse approaches that can be tailored to individual patient needs.

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Behavioral Intervention

NEW FED TR for Anorexia Nervosa (NEW FED TR Trial)

N/A

Waitlist Available

Led By Christina Wierenga, PhD

Research Sponsored by University of California, San Diego

Eligibility Criteria Checklist

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

Must have

Current diagnosis of anorexia nervosa

Be between 18 and 65 years old

Must not have

Current suicidal thoughts

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 3 months post-treatment

Awards & highlights

No Placebo-Only Group

Summary

This trial tests a new treatment for adults with anorexia nervosa that uses brain science to guide intensive therapy sessions involving the patient's family.

Who is the study for?

This trial is for adults who have been diagnosed with anorexia or anorexia nervosa at least two years ago and are medically stable. They must also have a carer willing to join them in treatment. People with current suicidal thoughts, recent substance abuse, developmental disorders, or severe psychiatric conditions like psychosis or bipolar disorder cannot participate.

What is being tested?

The study is testing NEW FED TR, which is a neurobiologically-informed intensive family-based treatment program designed specifically for adults suffering from anorexia nervosa.

What are the potential side effects?

Since this trial involves a skill-based program rather than medication, side effects may include emotional distress or discomfort during therapy sessions as participants work through their eating disorder challenges.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with anorexia nervosa.

Exclusion Criteria

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

Select...

I am experiencing thoughts of harming myself.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 3 months post-treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~3 months post-treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 3 months post-treatment for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Eating Disorder Examination Total Score

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: NEW FED TR for AnorexiaExperimental Treatment1 Intervention

NEW FED TR

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

Neurobiologically-guided intensive family-based treatment for Anorexia Nervosa leverages insights into the brain's role in the disorder and the critical influence of family dynamics. This approach targets the neurobiological underpinnings of Anorexia Nervosa, such as dysregulated reward processing and heightened anxiety responses, by involving family members in the treatment process. Family members are educated about the neurobiological aspects of the disorder and trained to support the patient through structured meal support and emotional regulation strategies. This method is crucial as it addresses both the biological and environmental factors contributing to Anorexia Nervosa, promoting a more holistic and supportive recovery environment.