Clinical trial NCT03261050: 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
Overall status: COMPLETED
Phase: NA
Conditions: Eating Disorder
Keywords: Eating disorder
Counter attitudinal therapy
fMRI
Lead sponsor: Stanford University
Sponsor class: OTHER
Collaborators: name: National Institute of Mental Health (NIMH)
First posted: 2017-08-24
Enrollment: 83
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 34
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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)

Primary outcomes:
measure: Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview
timeFrame: Week 8; R33 also reviews at 6-month follow-up
measure: Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview
timeFrame: Week 8; R33 also reviews at 6-month follow-up
measure: Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire
timeFrame: Week 8; R33 also reviews at 6-month follow-up
Secondary outcomes:
measure: Change in reward region of the brain using fMRI
timeFrame: Week 1 and Week 8
measure: Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)
timeFrame: Weeks 2, 4 and 6
measure: Change in negative affect using the Positive Affect and Negative Affect Scale-Revised
timeFrame: Weeks 2, 4, and 6
measure: Change in body dissatisfaction using the Body Dissatisfaction Scale
timeFrame: Weeks 2, 4 and 6
measure: Change in food addiction using the Yale Food Addiction Scale version 2.0
timeFrame: Weeks 2, 4, and 6
measure: Change in valuation of thin ideal using the Thin Ideal Valuation Scale
timeFrame: Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up
measure: Change in dietary restraint using the 10-item Dutch Restrained Eating Scale
timeFrame: Week 8; R33 also reviews at 6-month follow-up
measure: Change in implicit associations of binge foods, thin models, and eating disorder behavior words
timeFrame: Week 8; R33 also reviews at 6-month follow-up
Other outcomes:
Locations:
city: Stanford
country: United States
facility: Stanford University
state: California
city: Eugene
country: United States
facility: Oregon Research Institute
state: Oregon
Study officials:
affiliation: Oregon Research Institute
name: Eric Stice, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
citation: 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.
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.