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

NCT03261050 | Completed DMC

• 2 other identifiers: MH1117821R61MH111782
• Study Type: interventional
• Target: 83
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Eating Disorder

Keywords

Eating disorder; Counter attitudinal therapy; fMRI

Outcome Measures

Primary Outcomes (3)

• Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview

  Interviewer assesses frequency in binge eating episodes

  Week 8; R33 also reviews at 6-month follow-up

• Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview

  Interviewer assesses frequency of compensatory weight control behaviors

  Week 8; R33 also reviews at 6-month follow-up

• Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire

  Interviewer assesses change in psychosocial impairment

  Week 8; R33 also reviews at 6-month follow-up

Secondary Outcomes (8)

• Change in reward region of the brain using fMRI

  Week 1 and Week 8

• Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)

  Weeks 2, 4 and 6

• Change in negative affect using the Positive Affect and Negative Affect Scale-Revised

  Weeks 2, 4, and 6

• Change in body dissatisfaction using the Body Dissatisfaction Scale

  Weeks 2, 4 and 6

• Change in food addiction using the Yale Food Addiction Scale version 2.0

  Weeks 2, 4, and 6

Study Arms (2)

Body Project Treatment

EXPERIMENTAL

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.

Behavioral: Counter Attitudinal Therapy

Interpersonal Psychotherapy

ACTIVE COMPARATOR

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

Behavioral: Counter Attitudinal Therapy; Behavioral: Interpersonal Therapy

Interventions

Counter Attitudinal Therapy BEHAVIORAL

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

Body Project Treatment; Interpersonal Psychotherapy

Interpersonal Therapy BEHAVIORAL

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

Interpersonal Psychotherapy

Eligibility Criteria

• Age: 18 Years - 34 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Stanford University: lead
• National Institute of Mental Health (NIMH): collaborator

Study Sites (2)

Stanford University

Stanford, California, 94305, United States

Location

Oregon Research Institute

Eugene, Oregon, 97403, United States

Location

Related Publications (4)

• 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.

  PMID: 31403814 RESULT

• 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.

  PMID: 34635191 RESULT

• 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.

  PMID: 37486363 DERIVED

• 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.

  PMID: 33851199 DERIVED

MeSH Terms

Conditions

Feeding and Eating Disorders

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Mental Disorders

Study Officials

• Eric Stice, PhD

  Oregon Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Psychiatry and Behavioral Sciences

Study Record Dates

• First Submitted: August 17, 2017
• First Posted: August 24, 2017
• Study Start: July 10, 2017
• Primary Completion: January 24, 2025
• Study Completion: January 31, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR
• Time Frame: Descriptive/raw data will be submitted while the study is ongoing (every 6 months). Analyzed data will be submitted either when results are published or after the completion of the award period, whichever comes first.

Locations

US (2)