What is the mechanism of action of this treatment?

Cognitive Behavioral Therapy (CBT) is a common treatment for Anorexia Nervosa that focuses on changing maladaptive thought patterns and behaviors related to food, body image, and self-esteem. Enhancing set-shifting abilities, which refers to the cognitive flexibility to switch between tasks or thoughts, is particularly important in CBT for Anorexia Nervosa patients, as they often exhibit rigid thinking patterns. By improving set-shifting, CBT helps patients develop more adaptive coping strategies and reduces obsessive behaviors around food and body image. This matters for Anorexia Nervosa patients because it can lead to more sustainable recovery and improved quality of life. Other treatments, such as nutritional rehabilitation and family-based therapy, also play crucial roles by addressing the physical health and family dynamics that contribute to the disorder.

What side effects are associated with this type of intervention?

Cognitive Behavioral Therapy (CBT) for Anorexia Nervosa, including approaches that enhance set-shifting abilities, is generally well-tolerated with few side effects. Common side effects may include temporary increases in anxiety or distress as patients confront challenging thoughts and behaviors. Some patients may also experience frustration or emotional discomfort during the process of cognitive restructuring and exposure exercises. Overall, these side effects are typically mild and transient, and the benefits of CBT in improving symptoms and functioning often outweigh these temporary discomforts.

What prior FDA approvals exist?

As of now, there are no FDA-approved medications specifically for the treatment of Anorexia Nervosa. The primary treatment approach includes psychotherapy, particularly Cognitive Behavioral Therapy (CBT), which aims to address the cognitive distortions and behaviors associated with the disorder. Enhancing set-shifting abilities, a cognitive function often impaired in Anorexia Nervosa, is a focus of ongoing research but has not yet led to specific FDA-approved pharmacological treatments.

What other types of research exist?

One promising novel alternative to Cognitive Behavioral Therapy for Anorexia Nervosa patients is the use of Cognitive Remediation Therapy (CRT). CRT focuses on improving cognitive flexibility and set-shifting abilities, which are often impaired in individuals with AN. Additionally, combining CRT with other therapeutic approaches, such as music and art therapy, has shown potential in enhancing treatment outcomes. These therapies aim to address the cognitive deficits and improve overall treatment efficacy for AN patients.

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Behavioral Intervention

Cognitive Remediation Therapy for Anorexia

N/A

Recruiting

Led By Catherine Alix Timko, PhD

Research Sponsored by Children's Hospital of Philadelphia

Eligibility Criteria Checklist

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

Must have

Currently meets Diagnostic and Statistical Manual-5 criteria for Anorexia Nervosa

Medically stable for outpatient treatment

Must not have

Pregnant adolescent

No more than four sessions of prior CRT in any format

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline, during treatment, end of treatment

Awards & highlights

Summary

This trial tests if adding Cognitive Remediation Therapy (CRT) to Family Based Treatment (FBT) helps adolescents with Anorexia Nervosa (AN) by making their thinking more flexible. The goal is to see if this combined approach improves treatment outcomes. Cognitive Remediation Therapy (CRT) has been developed and tested for adolescents with anorexia nervosa to improve cognitive flexibility and holistic processing.

Who is the study for?

This trial is for adolescents aged 12-18 with Anorexia Nervosa who are stable enough for outpatient treatment and have no other major health issues. Parents or caregivers must be over 18, willing to participate, live with the adolescent, and provide medical clearance.

What is being tested?

The study tests if Cognitive Remediation Therapy (CRT) can improve 'set-shifting' (the ability to switch between tasks or thoughts) in teens with Anorexia Nervosa, potentially leading to better outcomes when combined with Family Based Treatment.

What are the potential side effects?

Since CRT involves psychological exercises rather than medication, typical side effects associated with drugs aren't expected. However, participants may experience stress or emotional discomfort during therapy sessions.

Eligibility Criteria

Inclusion Criteria

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

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I have been diagnosed with Anorexia Nervosa.

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I am stable enough to receive treatment without being hospitalized.

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My child has been diagnosed with AN.

Exclusion Criteria

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

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I am a pregnant teenager.

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I have had 4 or fewer sessions of chemotherapy or radiation therapy.

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I am not within the specified age range for adolescents.

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I have a brain condition or injury that might affect my treatment participation.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline, during treatment, end of treatment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline, during treatment, end of treatment

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline, during treatment, end of treatment for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Change in behavioral flexibility (amount consumed)

Change in behavioral flexibility (eating disorder behaviors)

Change in category switching flexibility

+9 more

Trial Design

2Treatment groups

Experimental Treatment

Active Control

Group I: FBT w/ Adolescent-focused Cognitive Remediation TherapyExperimental Treatment2 Interventions

Family Based Treatment with Adolescent-focused Cognitive Remediation Therapy (CRT): Families will receive 15 sessions of FBT over six months. The first 9 sessions of FBT will be preceded by adolescent-focused CRT.

Group II: Family Based Treatment (FBT)Active Control1 Intervention

Families will receive 15 sessions of FBT alone.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Cognitive Remediation Therapy

2014

Completed Phase 4

~960

Family Based Treatment

2017

N/A

~380

0 / 7Eligibility 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

Cognitive Behavioral Therapy (CBT) is a common treatment for Anorexia Nervosa that focuses on changing maladaptive thought patterns and behaviors related to food, body image, and self-esteem. Enhancing set-shifting abilities, which refers to the cognitive flexibility to switch between tasks or thoughts, is particularly important in CBT for Anorexia Nervosa patients, as they often exhibit rigid thinking patterns. By improving set-shifting, CBT helps patients develop more adaptive coping strategies and reduces obsessive behaviors around food and body image. This matters for Anorexia Nervosa patients because it can lead to more sustainable recovery and improved quality of life. Other treatments, such as nutritional rehabilitation and family-based therapy, also play crucial roles by addressing the physical health and family dynamics that contribute to the disorder.