Eating DisorderNCT03261050
Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders
A study testing Counter Attitudinal Therapy and Interpersonal Therapy in people with Eating Disorder, run by Stanford University at 2 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 to 34 years, women only
- Conditions the study is for
- Eating Disorder
- What is being tested?
- Counter Attitudinal Therapy and Interpersonal Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 83 participants
- Where
- 2 sitesUnited States
- Study dates
- 10 Jul 2017to 31 Jan 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 34 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- DSM-5 eating disorder
- Must have a primary care doctor
Who cannot join
- 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)
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Oregon Research Institute
Eugene, Oregon, 97403
Stanford University
Stanford, California, 94305
About this study
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.
Read the 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.
- Conditions
- Eating Disorder
- Being tested
- Counter Attitudinal Therapy, Interpersonal Therapy
- Keywords
- Eating disorder, Counter attitudinal therapy, fMRI
- Medical subject headings
- Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counter Attitudinal TherapyBehavioural
8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities.
Interpersonal TherapyBehavioural
8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities.
| Study group | Role | What they receive |
|---|---|---|
| Body Project Treatment | Experimental | An 8-session group-delivered eating disorder treatment that seeks to reduce valuation of the thin ideal and eating disordered behaviors used to pursue this ideal. Receives: Behavioral: Counter Attitudinal Therapy |
| Interpersonal Psychotherapy | Active comparator | An 8-session group-delivered eating disorder treatment that seeks to improve interpersonal functioning because this is theorized to maintain eating pathology. Receives: Behavioral: Counter Attitudinal Therapy; Behavioral: Interpersonal Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview
Interviewer assesses frequency in binge eating episodes
Measured: Week 8; R33 also reviews at 6-month follow-up
Change in occurrences of compensatory weight control behavior using Eating Disorder Diagnostic Interview
Interviewer assesses frequency of compensatory weight control behaviors
Measured: Week 8; R33 also reviews at 6-month follow-up
Change in psychosocial impairment due to eating disorder symptoms using the Clinical Impairment Assessment Questionnaire
Interviewer assesses change in psychosocial impairment
Measured: Week 8; R33 also reviews at 6-month follow-up
Secondary outcomes (8)
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)
Measured: Week 1 and Week 8
Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)
Assess if there are any changes in suicide ideation/attempts
Measured: Weeks 2, 4 and 6
Change in negative affect using the Positive Affect and Negative Affect Scale-Revised
Assess if there are any changes in negative affect
Measured: Weeks 2, 4, and 6
Change in body dissatisfaction using the Body Dissatisfaction Scale
Assess if there are any changes in body dissatisfaction
Measured: Weeks 2, 4 and 6
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)
Measured: Weeks 2, 4, and 6
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
Measured: Weeks 2, 4, 6, and 8; R33 also reviews at 6-month follow-up
Change in dietary restraint using the 10-item Dutch Restrained Eating Scale
Assess if there are any changes in dietary restraint
Measured: Week 8; R33 also reviews at 6-month follow-up
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)
Measured: Week 8; R33 also reviews at 6-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2017
- Study start10 Jul 2017
- Primary completion24 Jan 2025
- Study completion31 Jan 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Eating DisorderStudies of the same condition, open and under way.
- More trials run by Stanford UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 83 participants (actual)
Sponsor and investigators
- Lead sponsor
- Stanford University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Eric Stice, Stanford University
- Investigators
- Eric Stice, PhD, Principal investigator, Oregon Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03261050
- Sponsor's protocol ID
- MH111782
- Other IDs
- 1R61MH111782
- Status last verified
- Jun 2025
- First submitted
- 17 Aug 2017
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
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.
PubMed 31403814Stice 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.
PubMed 34635191Stice E, Yokum S, Rohde P, Bohon C, Shaw H. Randomized target engagement trial of a dissonance-based transdiagnostic eating disorder treatment versus transdiagnostic interpersonal psychotherapy. Psychol Med. 2025 Nov 6;55:e337. doi: 10.1017/S0033291725102341.
PubMed 41195733Stice E, Yokum S. Elevated reward, emotion, and memory region response to thin models predicts eating disorder symptom persistence: A prospective functional magnetic resonance imaging study. J Psychopathol Clin Sci. 2023 Aug;132(6):716-724. doi: 10.1037/abn0000843.
PubMed 37486363Yokum 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.
PubMed 33851199
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Target Engagement of a Novel Dissonance-Based Treatment for DSM-5 Eating Disorders
- ClinicalTrials.gov ID
- NCT03261050
- Acronym / sponsor ID
- MH111782
- Conditions
- Eating Disorder
- Keywords
- Eating disorder, Counter attitudinal therapy, fMRI
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 83 participants (actual)
- Lead sponsor
- Stanford UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 10 Jul 2017 (actual)
- Primary completion
- 24 Jan 2025 (actual)
- Study completion
- 31 Jan 2025 (actual)
- First posted
- 24 Aug 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Body Project Treatment | Experimental | Behavioral: Counter Attitudinal TherapyAn 8-session group-delivered eating disorder treatment that seeks to reduce valuation of the thin ideal and eating disordered behaviors used to pursue this ideal. |
| Interpersonal Psychotherapy | Active comparator | Behavioral: Counter Attitudinal Therapy, Behavioral: Interpersonal TherapyAn 8-session group-delivered eating disorder treatment that seeks to improve interpersonal functioning because this is theorized to maintain eating pathology. |
Who may qualify
- Ages
- 18 to 34 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- DSM-5 eating disorder
- Must have a primary care doctor
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Counter Attitudinal Therapy8 weekly 60 minute sessions of dissonance-based treatment wherein women with any eating disorder complete verbal, written, and behavioral activities. | Behavioural | Body Project Treatment, Interpersonal Psychotherapy |
| Interpersonal Therapy8 weekly 60 minute sessions of interpersonal-based treatment wherein women with an eating disorder complete verbal, written, and behavioral activities. | Behavioural | Interpersonal Psychotherapy |
Primary outcome
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
8 secondary outcomes
Change in reward region of the brain using fMRI
Time frame: Week 1 and Week 8
Change in suicidal ideation/attempts using the Patient Health Questionnaire version 9 (PHQ-9)
Time frame: Weeks 2, 4 and 6
Change in negative affect using the Positive Affect and Negative Affect Scale-Revised
Time frame: Weeks 2, 4, and 6
Change in body dissatisfaction using the Body Dissatisfaction Scale
Time frame: Weeks 2, 4 and 6
Change in food addiction using the Yale Food Addiction Scale version 2.0
Time frame: Weeks 2, 4, and 6
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
Change in dietary restraint using the 10-item Dutch Restrained Eating Scale
Time frame: Week 8; R33 also reviews at 6-month follow-up
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
- Results publication: PubMed 31403814Stice 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.
- Results publication: PubMed 34635191Stice 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.
- Derived from this study: PubMed 41195733Stice E, Yokum S, Rohde P, Bohon C, Shaw H. Randomized target engagement trial of a dissonance-based transdiagnostic eating disorder treatment versus transdiagnostic interpersonal psychotherapy. Psychol Med. 2025 Nov 6;55:e337. doi: 10.1017/S0033291725102341.
- Derived from this study: PubMed 37486363Stice E, Yokum S. Elevated reward, emotion, and memory region response to thin models predicts eating disorder symptom persistence: A prospective functional magnetic resonance imaging study. J Psychopathol Clin Sci. 2023 Aug;132(6):716-724. doi: 10.1037/abn0000843.
- Derived from this study: PubMed 33851199Yokum 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.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eric Stice, PhD principal investigator
Oregon Research Institute
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counter Attitudinal Therapy and Interpersonal Therapy in people with Eating Disorder, run by Stanford University at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in occurrences of binge eating episodes using Eating Disorder Diagnostic Interview (time frame: Week 8; R33 also reviews at 6-month follow-up). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03261050, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025.