Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders
|
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. |
| ClinicalTrials.gov Identifier: NCT03261050 |
|
Recruitment Status :
Recruiting
First Posted : August 24, 2017
Last Update Posted : May 27, 2022
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
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 |
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.
| 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 |
| Group/Cohort | Intervention/treatment |
|---|---|
|
R61 (Phase 1)
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 (Phase 2)
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. |
- 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
- 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
- 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
- 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 (Not collected during COVID-19 shelter-at-home order)
- 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
- 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
- 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
- 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 (Only collected during R61 phase)
- Change in valuation of thin ideal using the Thin Ideal Valuation Scale [ Time Frame: Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up ]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 [ Time Frame: Week 8; R33 also reviews at 6-month follow-up ]Assess if there are any changes in dietary restraint
- Change in implicit associations of binge foods, thin models, and eating disorder behavior words [ Time Frame: Week 8; R33 also reviews at 6-month follow-up ]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)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| Ages Eligible for Study: | 18 Years to 34 Years (Adult) |
| Sexes Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | Probability Sample |
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)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03261050
| Contact: Eric Stice, PhD | 541-484-2123 | estice@ori.org | |
| Contact: Sonja Yokum, PhD | 541-484-2123 | sonjas@ori.org |
| United States, California | |
| Stanford University | Recruiting |
| Stanford, California, United States, 94305 | |
| Contact: Ayotola Onipede, BA 560-723-7885 eatingbehaviortreatment@stanford.edu | |
| Principal Investigator: Eric Stice, PhD | |
| United States, Oregon | |
| Oregon Research Institute | Recruiting |
| Eugene, Oregon, United States, 97403 | |
| Contact: Sonya Sobel, BA 541-484-2123 eatingbehaviortreatment@ori.org | |
| Principal Investigator: Sonja Yokum, PhD | |
| United States, Texas | |
| The University of Texas at Austin | Completed |
| Austin, Texas, United States, 78712 | |
| Principal Investigator: | Eric Stice, PhD | Oregon Research Institute |
| Responsible Party: | Oregon Research Institute |
| ClinicalTrials.gov Identifier: | NCT03261050 |
| Other Study ID Numbers: |
MH111782 1R61MH111782 ( U.S. NIH Grant/Contract ) |
| First Posted: | August 24, 2017 Key Record Dates |
| Last Update Posted: | May 27, 2022 |
| Last Verified: | May 2022 |
| 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 |
|
Eating disorder Counter attitudinal therapy fMRI |
|
Disease Feeding and Eating Disorders Pathologic Processes Mental Disorders |