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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT03261050
Enrollment
83
Registered
2017-08-24
Start date
2017-07-10
Completion date
2025-01-31
Last updated
2025-06-11

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Eating Disorder

Keywords

Eating disorder, Counter attitudinal therapy, fMRI

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.

Interventions

BEHAVIORALCounter Attitudinal Therapy

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

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

Sponsors

National Institute of Mental Health (NIMH)
CollaboratorNIH
Stanford University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 34 Years
Healthy volunteers
No

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)

Design outcomes

Primary

MeasureTime frameDescription
Change in occurrences of binge eating episodes using Eating Disorder Diagnostic InterviewWeek 8; R33 also reviews at 6-month follow-upInterviewer assesses frequency in binge eating episodes
Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic InterviewWeek 8; R33 also reviews at 6-month follow-upInterviewer assesses frequency of compensatory weight control behaviors
Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment QuestionnaireWeek 8; R33 also reviews at 6-month follow-upInterviewer assesses change in psychosocial impairment

Secondary

MeasureTime frameDescription
Change in body dissatisfaction using the Body Dissatisfaction ScaleWeeks 2, 4 and 6Assess if there are any changes in body dissatisfaction
Change in food addiction using the Yale Food Addiction Scale version 2.0Weeks 2, 4, and 6Assess if there are any changes in food addiction (Only collected during R61 phase)
Change in reward region of the brain using fMRIWeek 1 and Week 8Assess 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 dietary restraint using the 10-item Dutch Restrained Eating ScaleWeek 8; R33 also reviews at 6-month follow-upAssess if there are any changes in dietary restraint
Change in implicit associations of binge foods, thin models, and eating disorder behavior wordsWeek 8; R33 also reviews at 6-month follow-upThree 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)
Change in valuation of thin ideal using the Thin Ideal Valuation ScaleWeeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-upAssess if there are any changes in valuation of the thin beauty ideal
Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)Weeks 2, 4 and 6Assess if there are any changes in suicide ideation/attempts
Change in negative affect using the Positive Affect and Negative Affect Scale-RevisedWeeks 2, 4, and 6Assess if there are any changes in negative affect

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 21, 2026