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

Eating Disorder Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03261050
• Other study ID #: MH111782
• Secondary ID: 1R61MH111782
• Status: Recruiting
• Phase: Phase 3
• Start date: July 10, 2017
• Est. completion date: July 31, 2024

Study information

• Verified date: November 2023
• Source: Stanford University
• Contact: Eric Stice, PhD
• Phone: 541-222-0615
• Email: estice[@]stanford.ed
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: July 31, 2024
• Est. primary completion date: July 15, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 34 Years

Eligibility

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)

Related Conditions & MeSH terms

• Eating Disorder
• Feeding and Eating Disorders

Intervention

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

Locations

Country	Name	City	State
United States	Oregon Research Institute	Eugene	Oregon
United States	Stanford University	Stanford	California

Sponsors (2)

Lead Sponsor	Collaborator
Stanford University	National Institute of Mental Health (NIMH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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	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)	Week 1 and Week 8
Secondary	Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)	Assess if there are any changes in suicide ideation/attempts	Weeks 2, 4 and 6
Secondary	Change in negative affect using the Positive Affect and Negative Affect Scale-Revised	Assess if there are any changes in negative affect	Weeks 2, 4, and 6
Secondary	Change in body dissatisfaction using the Body Dissatisfaction Scale	Assess if there are any changes in body dissatisfaction	Weeks 2, 4 and 6
Secondary	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)	Weeks 2, 4, and 6
Secondary	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	Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up
Secondary	Change in dietary restraint using the 10-item Dutch Restrained Eating Scale	Assess if there are any changes in dietary restraint	Week 8; R33 also reviews at 6-month follow-up
Secondary	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)	Week 8; R33 also reviews at 6-month follow-up