Exposure Therapy for Anorexia

Overseen By Jamal Essayli, Ph.D

Age: Any Age

Sex: Any

Trial Phase: Academic

Sponsor: Milton S. Hershey Medical Center

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

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 23

Duration: 20 weeks

30 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment for individuals with anorexia nervosa and related eating disorders. It employs exposure therapy, which helps participants face their fears about eating and weight gain through real-life and mental exercises. The goal is to determine if this approach can reduce anxiety and improve recovery outcomes. Individuals diagnosed with anorexia or similar conditions who continue to struggle with eating and weight-related fears might be suitable for this study.

As an unphased trial, this study provides a unique opportunity to contribute to understanding and potentially enhancing treatments for eating disorders.

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.

What prior data suggests that this protocol is safe for treating anorexia nervosa?

Research has shown that exposure therapy could be a helpful treatment for anorexia nervosa. Past studies found it reduces anxiety about eating and gaining weight. For instance, exposure therapy has helped some people eat foods they fear, lowering their anxiety and increasing their food intake.

One study found that focusing on specific fears with exposure therapy reduced anorexia symptoms, making it a promising method. Another study showed that different types of exposure therapy all led to fewer symptoms over time.

Overall, exposure therapy appears well-accepted. Studies have not reported any major safety concerns, suggesting it might be a safe option for those considering it as part of a clinical trial for anorexia nervosa. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike the standard treatments for anorexia, which often include nutritional counseling and cognitive-behavioral therapy (CBT), exposure therapy is unique because it directly targets the anxiety associated with eating and weight gain. This method uses inhibitory learning to help patients gradually face and reduce their fears, potentially leading to better treatment outcomes. Researchers are excited about this approach as it offers a new way to tackle the emotional and psychological barriers that contribute to anorexia, which could complement existing therapies and enhance recovery.

What evidence suggests that Exposure Therapy is effective for anorexia?

Research has shown that exposure therapy, which participants in this trial will receive, can help treat anorexia nervosa. This therapy involves gradually facing fears related to food and weight gain. One study found that it reduced anxiety and increased body weight in participants. Another review indicated that confronting real-life fears about certain foods might lower anxiety and improve eating. Early results suggest that exposure therapy helps people get used to their fears in a safe way, reducing fear over time. Overall, exposure therapy appears promising in helping people with anorexia nervosa manage anxiety and improve their eating habits. ^{1 2 6 7 8}

Who Is on the Research Team?

Jamal Essayli

Principal Investigator

Penn State University

Are You a Good Fit for This Trial?

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

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.

All individuals who are deemed to be, or become, unsafe by their supervising medical provider will be admitted to our hospital or another facility for medical stabilization.

Exclusion Criteria

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.

Participants at high risk for suicide will be excluded.

Timeline for a Trial Participant

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)

What Are the Treatments Tested in This Trial?

Interventions

• Exposure Therapy

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.

How Is the Trial Designed?

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.

Exposure Therapy is already approved in United States for the following indications:

Approved in United States as Prolonged Exposure Therapy for:

• Posttraumatic Stress Disorder (PTSD)

Who Is Running the Clinical Trial?

Milton S. Hershey Medical Center

Lead Sponsor

Trials

515

Recruited

2,873,000+

Published Research Related to This Trial

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]

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]

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]

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]

When cognitive behavioral therapy (CBT) is conducted effectively, the rate of adverse events is very low, comparable to or even lower than that of a placebo, indicating its safety and efficacy.

Many adverse events arise from poor-quality CBT due to therapists' insufficient training, highlighting the importance of regular patient assessments and supervision to ensure high standards in therapy delivery.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Adverse Events and Precautions Regarding Cognitive Behavioral Therapy]. Okmaoto, Y., Jinnin, R., Yoshino, A., et al.[2018]

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 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]

The novel methodology, BURDEN OF THERAPY (BOTh), effectively quantifies the presence and severity of treatment-emergent adverse events (TEAEs) on a daily basis during clinical studies, providing a more detailed understanding of patient experiences.

In two clinical studies, BOTh revealed significant differences in TEAE burdens between treatment groups, highlighting its sensitivity in evaluating safety and potentially guiding better treatment choices.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A novel standard to evaluate the impact of therapeutic agents on patient safety - The BURDEN OF THERAPY™©∗. Abdulahad, AK., Snijder, RJ., Panni, MK., et al.[2022]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12131494/

Predicting anorexia nervosa treatment efficacy - PubMed Central

This data-driven approach offers an unbiased means to uncover predictors of specific outcomes, advancing the understanding and management of this challenging ...

2.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0272735820300398

Exposure therapy for eating disorders: A systematic review

In vivo exposure to feared foods may decrease state anxiety and increase caloric intake and body mass index, but research is limited. Virtual reality exposure ...

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10215383/

Inhibitory Learning during Exposure Treatment in Anorexia ...

We present a practical guide for the implementation of exposure therapy in the treatment of anorexia nervosa.

4.

sciencedirect.com

sciencedirect.com/science/article/abs/pii/S0005789423000862

Facing Eating Disorder Fears: An Open Trial Adapting ...

ED symptoms and fears decreased from pre- to posttreatment and at 1-month follow-up. BMI increased significantly from pre- to posttreatment, particularly for ...

5.

jeatdisord.biomedcentral.com

jeatdisord.biomedcentral.com/articles/10.1186/s40337-023-00886-w

Psychotherapies for eating disorders: findings from a rapid ...

Research indicates psychotherapeutic interventions out-perform placebo, waitlist, and/or other treatments; but, outcomes vary with room for major improvement.

6.

jeatdisord.biomedcentral.com

jeatdisord.biomedcentral.com/articles/10.1186/s40337-024-01094-w

Anxiety matters: a pilot lab study into food, weight, and virtual ...

In addition, exposure therapy targeting individual fears in patients with anorexia nervosa led to symptom reduction and is a promising ...

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11090154/

Impact of three variants of prolonged exposure therapy on ...

Outcomes were assessed with clinical interviews at baseline, post-treatment and at 6- and 12-month follow-up. All variants of PE led to a decrease from baseline ...

8.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05596799?term=Eating%20Disorder&viewType=Table&rank=7

Facing Eating Disorder Fears for Anorexia Nervosa (FED-F)

Eating disorder symptoms and core eating disorder fears decrease during online imaginal exposure therapy for eating disorders. J Affect Disord. 2020 Nov 1 ...