Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders

NCT ID: NCT03261050

Last Updated: 2025-06-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

83 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-07-10

Study Completion Date

2025-01-31

Brief Summary

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Most people with an eating disorder (ED) do not receive good treatment. The investigators have developed a new brief group treatment that is supposed to work by reducing how much women with an ED value the impossible thinness standard promoted by the media and how much they value/crave binge foods. The investigators want to test whether the treatment actually changes those two mechanisms using brain scan data, which is more objective than completing questionnaires and even interviews.

In the first phase of the study (R61), the investigators will compare women in the treatment versus those on a wait-list. If the investigators can show that the treatment "works" (does what the investigators think it does) compared to no active treatment (women will be allowed to seek and receive outside help but investigators will not provide it until after the wait-list), investigators will conduct the second phase of study (R33),where they will randomly assign women with an ED to either the new treatment or to a group treatment that represents what many college mental health clinics provide to their clients with ED.

Detailed Description

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Only 3-20% of individuals with eating disorders (EDs) receive treatment, and those who do rarely receive evidence-based treatments because they are very intensive and costly, few clinicians deliver them, and they differ for the various EDs. These factors have hindered broad implementation of evidence-based treatments, implying that a brief frontline outpatient treatment for a range of EDs that could be easily, cheaply, and widely implemented would address a major public health problem. There is also limited experimental evidence regarding factors that maintain EDs and mechanisms of action for ED treatments. The investigators propose to conduct a project that translates basic persuasion research into clinical hypotheses and a novel treatment.

The investigators hypothesize that EDs are maintained by (1) excessive valuation of the thin beauty ideal, which prompts caloric restriction and other unhealthy weight control behaviors (vomiting, laxative use, excessive exercise) that increase binge eating risk, and (2) excessive valuation of high-calorie foods, which maintains binge eating. The investigators propose to evaluate a treatment that addresses these hypothesized maintenance processes. Two pilot trials evaluated a novel 8-session group dissonance-based treatment (Counter Attitudinal Therapy; CAT) wherein women with any ED appropriate for outpatient care completed activities in which they collectively discuss costs of pursuing the thin ideal and the ED behaviors in which they personally engage (unhealthy weight control behaviors and binge eating), which putatively creates dissonance about engaging in those particular behaviors that reduce valuation of the thin ideal and high-calorie binge foods.

During the COVID-19 shelter-at-home orders taking place at both research sites, the investigators will not measure in-person only outcomes including fMRI, ECG, computerized implicit associated tests, and height and weight measurements for all participants that have assessments during this order. The investigators will continue to conduct treatment groups that will be administered on a virtual platform.

Conditions

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Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Body Project Treatment

An 8-session group-delivered eating disorder treatment that seeks to reduce valuation of the thin ideal and eating disordered behaviors used to pursue this ideal.

Group Type EXPERIMENTAL

Counter Attitudinal Therapy

Intervention Type BEHAVIORAL

8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.

Interpersonal Psychotherapy

An 8-session group-delivered eating disorder treatment that seeks to improve interpersonal functioning because this is theorized to maintain eating pathology.

Group Type ACTIVE_COMPARATOR

Counter Attitudinal Therapy

Intervention Type BEHAVIORAL

8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.

Interpersonal Therapy

Intervention Type BEHAVIORAL

8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.

Interventions

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Counter Attitudinal Therapy

8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.

Intervention Type BEHAVIORAL

Interpersonal Therapy

8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.

Intervention Type BEHAVIORAL

Eligibility Criteria

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Inclusion Criteria

* DSM-5 eating disorder
* Must have a primary care doctor

Exclusion Criteria

* Non-English speakers
* BMI \<75% ideal body weight
* Current acute suicidal ideation (defined as thoughts of a specific method or plan)
* Comorbid psychiatric disorder that would disrupt groups (e.g., bipolar disorder, substance misuse)
* Serious medical problems (e.g., diabetes)
Minimum Eligible Age

18 Years

Maximum Eligible Age

34 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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National Institute of Mental Health (NIMH)

NIH

Sponsor Role collaborator

Stanford University

OTHER

Sponsor Role lead

Responsible Party

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Eric Stice

Professor of Psychiatry and Behavioral Sciences

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Eric Stice, PhD

Role: PRINCIPAL_INVESTIGATOR

Oregon Research Institute

Locations

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Stanford University

Stanford, California, United States

Site Status

Oregon Research Institute

Eugene, Oregon, United States

Site Status

Countries

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United States

References

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Stice E, Yokum S, Rohde P, Shaw H, Gau JM, Johnson S, Johns A. Randomized trial of a dissonance-based transdiagnostic group treatment for eating disorders: An evaluation of target engagement. J Consult Clin Psychol. 2019 Sep;87(9):772-786. doi: 10.1037/ccp0000430.

Reference Type RESULT
PMID: 31403814 (View on PubMed)

Stice E, Yokum S, Rohde P, Gau J, Shaw H. Evidence that a novel transdiagnostic eating disorder treatment reduces reward region response to the thin beauty ideal and high-calorie binge foods. Psychol Med. 2023 Apr;53(6):2252-2262. doi: 10.1017/S0033291721004049. Epub 2021 Oct 12.

Reference Type RESULT
PMID: 34635191 (View on PubMed)

Stice E, Yokum S. Elevated reward, emotion, and memory region response to thin models predicts eating disorder symptom persistence: A prospective functional magnetic resonance imaging study. J Psychopathol Clin Sci. 2023 Aug;132(6):716-724. doi: 10.1037/abn0000843.

Reference Type DERIVED
PMID: 37486363 (View on PubMed)

Yokum S, Bohon C, Berkman E, Stice E. Test-retest reliability of functional MRI food receipt, anticipated receipt, and picture tasks. Am J Clin Nutr. 2021 Aug 2;114(2):764-779. doi: 10.1093/ajcn/nqab096.

Reference Type DERIVED
PMID: 33851199 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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1R61MH111782

Identifier Type: NIH

Identifier Source: secondary_id

View Link

MH111782

Identifier Type: -

Identifier Source: org_study_id

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