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

• ClinicalTrials.gov Identifier: NCT03261050
• Recruitment Status: Recruiting
• First Posted: August 24, 2017
• Last Update Posted: July 18, 2019
• Sponsor: Oregon Research Institute
• Collaborator: National Institute of Mental Health (NIMH)
• Information provided by (Responsible Party): Oregon Research Institute

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.

Condition or disease	Intervention/treatment
Eating Disorder	Behavioral: Counter Attitudinal Therapy; Behavioral: Interpersonal Therapy

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.

Study Design

• Study Type: Observational
• Estimated Enrollment: 180 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders
• Actual Study Start Date: July 10, 2017
• Estimated Primary Completion Date: June 2022
• Estimated Study Completion Date: June 2022

Groups and Cohorts

Group/Cohort	Intervention/treatment
R61; In R61, participants are randomly assigned to either the treatment group or the wait-list condition. Participants assigned to the treatment group receive Counter Attitudinal Therapy (CAT). Participants in the treatment group are compared with participants in the wait-list condition. Participants will complete target and outcome measures at pretest and posttest, plus self-report intervention target and outcome measures at weeks 2, 4, and 6 during treatment for dosage analysis. Additionally, at pre-test and post-test participants will complete two MRI brain scans where they will be exposed to pictures of women and different types of foods. This will assess participants' thin-ideal and binge food valuation. Electrocardiography (ECG) data will be collected at pre and post.	Behavioral: Counter Attitudinal Therapy; 8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.
R33; In R33, participants from wait-list condition are assigned to receive either Counter Attitudinal Therapy or Interpersonal Therapy. Participants will complete target and outcome measures at pretest and posttest, including a 6-month follow-up, plus self-report intervention target and outcome measures at weeks 2, 4, and 6 during treatment for dosage analysis. At pre-test and post-test participants will complete two MRI brain scans where they will be exposed to pictures of women and different types of foods. This will assess participants' thin-ideal and binge food valuation. Additionally, thin-ideal valuation will be accessed outside the scanner at pre, post and follow-up. Similarly, binge food valuation will be accessed outside the scanner at pre, post, and follow-up and weeks 2, 4, and 6 during treatment for dose-response analysis. Electrocardiography (ECG) data will be collected at pre and post.	Behavioral: Counter Attitudinal Therapy; 8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.; Behavioral: Interpersonal Therapy; 8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.

Outcome Measures

Primary Outcome Measures :

1. Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview [ Time Frame: Week 8; R33 also reviews at 6-month follow-up ]
   Interviewer assesses frequency in binge eating episodes
2. Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview [ Time Frame: Week 8; R33 also reviews at 6-month follow-up ]
   Interviewer assesses frequency of compensatory weight control behaviors
3. Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire [ Time Frame: Week 8; R33 also reviews at 6-month follow-up ]
   Interviewer assesses change in psychosocial impairment

Secondary Outcome Measures :

1. Change in reward region of the brain using fMRI [ Time Frame: Week 1 and Week 8 ]
   Assess if CAT produces larger pre-post reductions in reward region in response to thin models and binge food
2. Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9) [ Time Frame: Weeks 2, 4 and 6 ]
   Assess if there are any changes in suicide ideation/attempts
3. Change in negative affect using the Positive Affect and Negative Affect Scale-Revised [ Time Frame: Weeks 2, 4, and 6 ]
   Assess if there are any changes in negative affect
4. Change in body dissatisfaction using the Body Dissatisfaction Scale [ Time Frame: Weeks 2, 4 and 6 ]
   Assess if there are any changes in body dissatisfaction
5. Change in food addiction using the Yale Food Addiction Scale version 2.0 [ Time Frame: Weeks 2, 4, and 6 ]
   Assess if there are any changes in food addiction

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 34 Years (Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No
• Sampling Method: Probability Sample

Study Population

Subjects for the initial R61 phase will be 60 women over 18 years with body image and eating problems interested in participating in a trial of interventions aimed at improving body image and eating disorders, and for the R33 phase will consist of 120 women with DSM-5 eating disorders.

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)

Contacts and Locations

Contacts

Contact: Eric Stice, PhD; 541-484-2123; estice@ori.org

Contact: Paul Rohde, PhD; 541-484-2123; paulr@ori.org

Locations

United States, California

Stanford University; Not yet recruiting

Stanford, California, United States, 94305

Contact: Cara Bohon, PhD 650-723-2300 cbohon@stanford.edu

United States, Oregon

Oregon Research Institute; Recruiting

Eugene, Oregon, United States, 97403

Contact: Paul Rhode, PhD 541-484-2123 paulr@ori.org

Contact: Sonja Yokum, PhD 541-484-2123 sonjas@ori.org

Principal Investigator: Eric Stice, PhD

United States, Texas

The University of Texas at Austin; Completed

Austin, Texas, United States, 78712

Sponsors and Collaborators

Oregon Research Institute

National Institute of Mental Health (NIMH)

Investigators

• Principal Investigator: Eric Stice, PhD; Oregon Research Institute

More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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.

• Responsible Party: Oregon Research Institute
• ClinicalTrials.gov Identifier: NCT03261050 History of Changes
• Other Study ID Numbers: MH111782; 1R61MH111782 ( U.S. NIH Grant/Contract )
• First Posted: August 24, 2017
• Last Update Posted: July 18, 2019
• Last Verified: July 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• 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.
• Supporting Materials: Study Protocol; Clinical Study Report (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.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Oregon Research Institute:

Eating disorder; Counter attitudinal therapy; fMRI

Additional relevant MeSH terms:

Disease; Feeding and Eating Disorders; Pathologic Processes; Mental Disorders