Exposure Therapy for Anorexia

Overseen by Jamal Essayli

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Milton S. Hershey Medical Center

Disqualifiers: Bulimia nervosa, High suicide risk, Pregnant, Psychotic disorder, others

No Placebo Group

Approved in 1 Jurisdiction

Trial Summary

What is the purpose of this trial?

The current proposal will evaluate the feasibility, acceptability, and preliminary efficacy of Exposure Therapy for anorexia nervosa (AN) spectrum disorders (Exp-AN), an innovative treatment rooted in principles of inhibitory learning. Exp-AN will target anxiety about both eating and weight gain by combining in vivo (i.e., in real life) and imaginal (i.e., mental) exposure in novel ways (e.g., eating a feared food while listening to a recording describing fears about weight gain).

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 exposure therapy generally safe for humans?

Exposure therapy, like other psychotherapies, can have adverse events (unwanted effects), affecting more than one in ten participants, with serious events occurring in more than one in 21 participants. However, the way these events are recorded and reported varies, making it hard to compare results across studies. ^{1 2 3 4 5}

How is exposure therapy different from other treatments for anorexia?

Exposure therapy for anorexia is unique because it focuses on reducing anxiety and avoidance behaviors related to food and body image, which are key factors in maintaining the disorder. Unlike traditional treatments, it uses techniques like virtual reality to help patients confront and reduce their fears in a controlled environment. ^{6 7 8 9 10}

Research Team

Jamal Essayli

Principal Investigator

Penn State University

Eligibility Criteria

This trial is for adults with eating disorders, specifically those who have been diagnosed with anorexia or anorexia nervosa. Participants should be open to trying a new therapy that involves facing their fears about eating and weight gain.

Inclusion Criteria

I am between 18 and 65, speak English, and have been diagnosed with an anorexia nervosa spectrum disorder.

Diagnoses will be determined using the Structured Clinical Interview for DSM-5 - Research Version (SCID-5-RV).

All participants in this study will be monitored by a Penn State Health medical provider.

Exclusion Criteria

I am 18 years old or older.

Non-English speakers will be excluded due to lack of funding to translate the measures to other languages.

Individuals with other EDs (e.g., bulimia nervosa) will be excluded.

Trial Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Treatment

Participants undergo Exposure Therapy for anorexia nervosa, focusing on anxiety related to eating and weight gain through in vivo and imaginal exposure.

20 weeks

20 sessions (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Treatment Details

Interventions

• Exposure Therapy (Behavioral Intervention)

Trial Overview The study is testing Exposure Therapy for individuals with anorexia spectrum disorders. It aims to reduce anxiety related to eating and gaining weight by combining real-life experiences (like eating feared foods) with mental exercises.

Participant Groups

Group I: Exposure Therapy Experimental Treatment 1 Intervention

Exp-AN will effectively target anxiety related to eating and weight gain via inhibitory learning, and improve treatment outcomes.

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Findings from Research

A systematic review of 85 randomized controlled trials involving 14,420 participants found that adverse events (AEs) from psychotherapy can affect more than 10% of participants, with serious AEs occurring in more than 1 in 21 participants.

The study highlighted that the reporting and recording of AEs were inconsistent across trials, suggesting a need for standardized harm monitoring to better evaluate the risks and benefits of psychotherapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. Klatte, R., Strauss, B., Flückiger, C., et al.[2023]

In a review of 24 patients experiencing skin-related side effects from cancer treatments, phototherapy was found to improve cutaneous adverse events in 96% of cases, demonstrating its efficacy as a noninvasive treatment option.

Phototherapy can be safely administered alongside ongoing cancer therapies, with most patients continuing their cancer treatment while receiving phototherapy, indicating its potential as an effective adjunctive therapy for managing skin toxicities.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

An overview of the efficacy of phototherapy in oncodermatology. Park, C., Korman, AM., Dulmage, BL.[2022]

In a study analyzing 194 adverse events from 3222 patients in an emergency department, errors of commission (55%) were linked to prior events, while errors of omission (45%) were associated with emergency department events, highlighting different underlying causes for these errors.

The most frequent adverse events were drug reactions, which had a lower preventability score, indicating that these reactions are harder to prevent, while diagnostic issues were linked to higher preventability, suggesting they could be more easily addressed in emergency care.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Experience in adverse events detection in an emergency department: nature of events. Hendrie, J., Sammartino, L., Silvapulle, MJ., et al.[2007]

A study involving 54 adolescents in a partial hospitalization program showed that exposure therapy with feared foods can help reduce anxiety over time, particularly when there is weight gain, indicating that between-session habituation is beneficial for treatment outcomes.

However, the study found that while anxiety decreased between sessions, it did not decrease within sessions, suggesting that within-session habituation may not be as important for achieving favorable results in treating eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The impact of between-session habituation, within-session habituation, and weight gain on response to food exposure for adolescents with eating disorders. Essayli, JH., Forrest, LN., Zickgraf, HF., et al.[2023]

The study demonstrated that virtual reality (VR) body exposure therapy, when integrated with cognitive behavioral therapy, significantly reduced symptoms of anorexia nervosa (AN) such as fear of gaining weight, body anxiety, and drive for thinness in a patient, with improvements maintained for 5 months after treatment.

Body mass index (BMI) increased to healthy levels during the intervention, indicating that VR therapy may effectively address body image disturbances and promote healthier body perceptions in individuals with AN.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Virtual Reality Body Exposure Therapy for Anorexia Nervosa. A Case Report With Follow-Up Results. Porras-Garcia, B., Serrano-Troncoso, E., Carulla-Roig, M., et al.[2022]

Exposure therapy can be an effective intervention for treating anxiety-related factors in anorexia nervosa, which are often linked to avoidance behaviors and fears surrounding food and weight.

A practical guide is provided for implementing exposure therapy in anorexia nervosa, illustrated by a case study of a patient who underwent 31 sessions targeting her specific fears and avoidance behaviors, demonstrating the therapy's potential application.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Inhibitory Learning during Exposure Treatment in Anorexia Nervosa: A Practical Guide. Melles, H., Duijvis, S., Jansen, A.[2023]

The Fear of Food Measure (FOFM) was developed and validated across four studies, demonstrating its effectiveness in assessing anxiety and avoidance behaviors related to eating in individuals with anorexia nervosa (AN).

In a clinical sample, the FOFM showed that anxiety about eating predicted food intake and decreased significantly after a four-session exposure therapy, indicating its potential utility in monitoring treatment progress and targeting specific behaviors in therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The fear of food measure: a novel measure for use in exposure therapy for eating disorders. Levinson, CA., Byrne, M.[2018]

A study involving 125 eating disorder providers found that framing exposure therapy as a 'behavioral experiment' increased the likelihood of providers endorsing its use compared to framing it as traditional exposure or acceptance-based therapy.

Providers with more specialized training in eating disorder exposure therapy were more inclined to use exposure methods, suggesting that improved training and clear communication about the benefits of exposure therapy could enhance its adoption in treating eating disorders.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Manipulating the theoretical framing of exposure therapy for eating disorders impacts clinicians' treatment preferences. Levinson, CA., Christian, C., Vanzhula, IA.[2021]

References

1. England pubmed.ncbi.nlm.nih.gov

Adverse events in psychotherapy randomized controlled trials: A systematic review. [2023]

2. Germany pubmed.ncbi.nlm.nih.gov

An overview of the efficacy of phototherapy in oncodermatology. [2022]

3. Japan pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. [2018]

4. Netherlands pubmed.ncbi.nlm.nih.gov

A novel standard to evaluate the impact of therapeutic agents on patient safety - The BURDEN OF THERAPY™©∗. [2022]

5. Australia pubmed.ncbi.nlm.nih.gov

Experience in adverse events detection in an emergency department: nature of events. [2007]

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

The impact of between-session habituation, within-session habituation, and weight gain on response to food exposure for adolescents with eating disorders. [2023]

7. Switzerland pubmed.ncbi.nlm.nih.gov

Virtual Reality Body Exposure Therapy for Anorexia Nervosa. A Case Report With Follow-Up Results. [2022]

8. Switzerland pubmed.ncbi.nlm.nih.gov

Inhibitory Learning during Exposure Treatment in Anorexia Nervosa: A Practical Guide. [2023]

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

The fear of food measure: a novel measure for use in exposure therapy for eating disorders. [2018]

10. Germany pubmed.ncbi.nlm.nih.gov

Manipulating the theoretical framing of exposure therapy for eating disorders impacts clinicians' treatment preferences. [2021]