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

Primary Purpose

Eating Disorder

Status
Recruiting
Phase
Phase 3
Locations
United States
Study Type
Interventional
Intervention
Counter Attitudinal Therapy
Interpersonal Therapy
Sponsored by
Stanford University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorder focused on measuring Eating disorder, Counter attitudinal therapy, fMRI

Eligibility Criteria

18 Years - 34 Years (Adult)FemaleDoes not accept healthy volunteers

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)

Sites / Locations

  • Stanford UniversityRecruiting
  • Oregon Research InstituteRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Body Project Treatment

Interpersonal Psychotherapy

Arm Description

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.

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

Outcomes

Primary Outcome Measures

Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview
Interviewer assesses frequency in binge eating episodes
Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview
Interviewer assesses frequency of compensatory weight control behaviors
Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire
Interviewer assesses change in psychosocial impairment

Secondary Outcome Measures

Change in reward region of the brain using fMRI
Assess if CAT produces larger pre-post reductions in reward region in response to thin models and binge food (Not collected during COVID-19 shelter-at-home order)
Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)
Assess if there are any changes in suicide ideation/attempts
Change in negative affect using the Positive Affect and Negative Affect Scale-Revised
Assess if there are any changes in negative affect
Change in body dissatisfaction using the Body Dissatisfaction Scale
Assess if there are any changes in body dissatisfaction
Change in food addiction using the Yale Food Addiction Scale version 2.0
Assess if there are any changes in food addiction (Only collected during R61 phase)
Change in valuation of thin ideal using the Thin Ideal Valuation Scale
Assess if there are any changes in valuation of the thin beauty ideal
Change in dietary restraint using the 10-item Dutch Restrained Eating Scale
Assess if there are any changes in dietary restraint
Change in implicit associations of binge foods, thin models, and eating disorder behavior words
Three implicit association tasks will assess response to binge foods, thin models, and eating disorder behavior words at pre- and post-test (Not collected during COVID-19 shelter-at-home order)

Full Information

First Posted
August 17, 2017
Last Updated
October 12, 2023
Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)
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1. Study Identification

Unique Protocol Identification Number
NCT03261050
Brief Title
Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders
Official Title
Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 10, 2017 (Actual)
Primary Completion Date
July 15, 2024 (Anticipated)
Study Completion Date
July 31, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Stanford University
Collaborators
National Institute of Mental Health (NIMH)

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorder
Keywords
Eating disorder, Counter attitudinal therapy, fMRI

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
80 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Body Project Treatment
Arm Type
Experimental
Arm Description
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.
Arm Title
Interpersonal Psychotherapy
Arm Type
Active Comparator
Arm Description
An 8-session group-delivered eating disorder treatment that seeks to improve interpersonal functioning because this is theorized to maintain eating pathology.
Intervention Type
Behavioral
Intervention Name(s)
Counter Attitudinal Therapy
Intervention Description
8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.
Intervention Type
Behavioral
Intervention Name(s)
Interpersonal Therapy
Intervention Description
8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.
Primary Outcome Measure Information:
Title
Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview
Description
Interviewer assesses frequency in binge eating episodes
Time Frame
Week 8; R33 also reviews at 6-month follow-up
Title
Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview
Description
Interviewer assesses frequency of compensatory weight control behaviors
Time Frame
Week 8; R33 also reviews at 6-month follow-up
Title
Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire
Description
Interviewer assesses change in psychosocial impairment
Time Frame
Week 8; R33 also reviews at 6-month follow-up
Secondary Outcome Measure Information:
Title
Change in reward region of the brain using fMRI
Description
Assess if CAT produces larger pre-post reductions in reward region in response to thin models and binge food (Not collected during COVID-19 shelter-at-home order)
Time Frame
Week 1 and Week 8
Title
Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)
Description
Assess if there are any changes in suicide ideation/attempts
Time Frame
Weeks 2, 4 and 6
Title
Change in negative affect using the Positive Affect and Negative Affect Scale-Revised
Description
Assess if there are any changes in negative affect
Time Frame
Weeks 2, 4, and 6
Title
Change in body dissatisfaction using the Body Dissatisfaction Scale
Description
Assess if there are any changes in body dissatisfaction
Time Frame
Weeks 2, 4 and 6
Title
Change in food addiction using the Yale Food Addiction Scale version 2.0
Description
Assess if there are any changes in food addiction (Only collected during R61 phase)
Time Frame
Weeks 2, 4, and 6
Title
Change in valuation of thin ideal using the Thin Ideal Valuation Scale
Description
Assess if there are any changes in valuation of the thin beauty ideal
Time Frame
Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up
Title
Change in dietary restraint using the 10-item Dutch Restrained Eating Scale
Description
Assess if there are any changes in dietary restraint
Time Frame
Week 8; R33 also reviews at 6-month follow-up
Title
Change in implicit associations of binge foods, thin models, and eating disorder behavior words
Description
Three implicit association tasks will assess response to binge foods, thin models, and eating disorder behavior words at pre- and post-test (Not collected during COVID-19 shelter-at-home order)
Time Frame
Week 8; R33 also reviews at 6-month follow-up

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
34 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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)
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Eric Stice, PhD
Phone
541-222-0615
Email
estice@stanford.ed
First Name & Middle Initial & Last Name or Official Title & Degree
Sonja Yokum, PhD
Phone
541-484-2123
Email
sonjas@ori.org
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Organizational Affiliation
Oregon Research Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
Stanford University
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ayotola Onipede, BA
Phone
560-723-7885
Email
eatingbehaviortreatment@stanford.edu
First Name & Middle Initial & Last Name & Degree
Eric Stice, PhD
Facility Name
Oregon Research Institute
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97403
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sonya Sobel, BA
Phone
541-484-2123
Email
eatingbehaviortreatment@ori.org
First Name & Middle Initial & Last Name & Degree
Sonja Yokum, PhD

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
Study data will be shared via the National Database for Clinical Trials Related to Mental Illness (NDCT), which is part of the NIMH Data Archive (NDA). All data, with the exception of video recordings of the participants in treatment, will be provided.
IPD Sharing 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.
Citations:
PubMed Identifier
33851199
Citation
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.
Results Reference
derived
PubMed Identifier
31403814
Citation
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.
Results Reference
derived

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

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