Bulimia NervosaNCT04625959
Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
A study testing Behavioral Therapy for Eating Disorders, MABT: Mindful Awareness and MABT: Values in people with Bulimia Nervosa and Bulimia; Atypical, run by Drexel University at 1 site in United States.
Trial summary
The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bulimia Nervosa, Bulimia; Atypical, Binge-Eating Disorder
- What is being tested?
- Behavioral Therapy for Eating Disorders, MABT: Mindful Awareness and MABT: Values
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Jun 2020to Apr 2024
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Have experienced 12 or more loss of control episodes within the previous 3 months
- Have a BMI above 16
- Are located in the US and wiling/able to participate in remote treatment and assessments
- Are able to give consent
Who cannot join
- Are unable to fluently speak, write and read English
- Have a BMI below 16
- Are receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University, Stratton Hall
Philadelphia, Pennsylvania, 19104
About this study
The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. The primary aim of the study will be to evaluate the independent efficacy of Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). Secondary aims will be (1) to test target engagement of each MABT component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the Distress Tolerance component). A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that components may partially depend on each other).
- Conditions
- Bulimia Nervosa, Bulimia; Atypical, Binge-Eating Disorder, Binge-Eating and Purging Type Anorexia Nervosa, Binge Eating
- Being tested
- Behavioral Therapy for Eating Disorders, MABT: Mindful Awareness, MABT: Values, MABT: Emotion Modulation, MABT: Distress Tolerance
- Keywords
- Mindfulness and Acceptance Based Behavioral Treatments, Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Anorexia Nervosa Binge/Purge Type, Binge Eating
- Medical subject headings
- Bulimia Nervosa, Bulimia, Binge-Eating Disorder, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Behavioral Therapy for Eating DisordersBehavioural
Change behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns).
MABT: Mindful AwarenessBehavioural
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically mindful awareness, designed to enhance self-regulation. Mindful awareness strategies include developing inner and outer wisdom, formal meditation, and shifting awareness to the present moment. Mindful awareness skills also include increasing awareness of thoughts, feelings, physical sensations, and hunger and fullness cues.
MABT: ValuesBehavioural
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically values, designed to enhance self-regulation. Values skills include identifying and clarifying values, living a values life, making values-consistent decisions, addressing competing values, values awareness, and using values to address negative moods.
MABT: Emotion ModulationBehavioural
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically emotion modulation, designed to enhance self-regulation. Emotion modulation skills include long-term habits for emotion regulation, coping strategies, crisis management, and cognitive reappraisal.
MABT: Distress ToleranceBehavioural
Integrates behavioral treatment for eating disorders with a set of psychological strategies, specifically distress tolerance, designed to enhance self-regulation. Distress tolerance skills include psychological acceptance, uncoupling, willingness, and dealing with dirty distress.
| Study group | Role | What they receive |
|---|---|---|
| Base BT | Active comparator | 16 weekly sessions of behavioral therapy. Receives: Behavioral: Behavioral Therapy for Eating Disorders |
| Base BT + Distress Tolerance | Experimental | 16 weekly sessions of behavioral therapy with distress tolerance components of MABTs. Receives: Behavioral: MABT: Distress Tolerance |
| Base BT + Emotion Regulation | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation components of MABTs. Receives: Behavioral: MABT: Emotion Modulation |
| Base BT + Mindful Awareness | Experimental | 16 weekly sessions of behavioral therapy with mindful awareness components of MABTs. Receives: Behavioral: MABT: Mindful Awareness |
| Base BT + Values | Experimental | 16 weekly sessions of behavioral therapy with values components of MABTs. Receives: Behavioral: MABT: Values |
| Base BT + Distress Tolerance and Emotion Modulation | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs. Receives: Behavioral: MABT: Emotion Modulation; Behavioral: MABT: Distress Tolerance |
| Base BT + Distress Tolerance and Mindful Awareness | Experimental | 16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs. Receives: Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Distress Tolerance |
| Base BT + Distress Tolerance and Values | Experimental | 16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs. Receives: Behavioral: MABT: Values; Behavioral: MABT: Distress Tolerance |
| Base BT + Emotion Modulation and Mindful Awareness | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs. Receives: Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Emotion Modulation |
| Base BT + Mindful Awareness and Values | Experimental | 16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs. Receives: Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Values |
| Base BT + Emotion Modulation and Values | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs. Receives: Behavioral: MABT: Values; Behavioral: MABT: Emotion Modulation |
| Base BT + EM, DT, MA | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs. Receives: Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Emotion Modulation; Behavioral: MABT: Distress Tolerance |
| Base BT + DT, ER, and V | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs. Receives: Behavioral: MABT: Values; Behavioral: MABT: Emotion Modulation; Behavioral: MABT: Distress Tolerance |
| Base BT + DT, MA, and V | Experimental | 16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs. Receives: Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Values; Behavioral: MABT: Distress Tolerance |
| Base BT + ER, MA, and V | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs. Receives: Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Values; Behavioral: MABT: Emotion Modulation |
| Base BT + ER, MA, V, DT | Experimental | 16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs. Receives: Behavioral: MABT: Mindful Awareness; Behavioral: MABT: Values; Behavioral: MABT: Emotion Modulation; Behavioral: MABT: Distress Tolerance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge eating frequency assessed by the Eating Disorder Examination
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment
Eating Disorder Examination
The Eating Disorder Examination is a semi-structured interview that measures eating pathology. The EDE yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE will be used to assess utilization of skills related to reducing dietary restraint.
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Remission Status
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Secondary outcomes (2)
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Frequency (number of days and number of instances) of compensatory behaviors assessed by the Eating Disorder Examination
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
BMI
kilogram/(meters^2), this is an outcome measure for participants with anorexia nervosa, binge/purge type
Measured: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Nov 2020
- Study start5 Jun 2020
- Primary completionApr 2024 (estimated)
- Study completionApr 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bulimia NervosaStudies of the same condition, open and under way.
- 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
- Factorial
- Model description
- MOST: multiphase optimization strategy
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 256 participants (actual)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04625959
- Sponsor's protocol ID
- 2001007570
- Status last verified
- Sep 2023
- First submitted
- 16 Sep 2020
- Last updated
- 25 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Mindfulness and Acceptance Based Behavioral Treatment for Bulimia Nervosa and Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT04625959
- Acronym / sponsor ID
- 2001007570
- Conditions
- Bulimia Nervosa, Bulimia; Atypical, Binge-Eating Disorder, Binge-Eating and Purging Type Anorexia Nervosa, Binge Eating
- Keywords
- Mindfulness and Acceptance Based Behavioral Treatments, Eating Disorders, Bulimia Nervosa, Binge Eating Disorder, Anorexia Nervosa Binge/Purge Type, Binge Eating
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 5 Jun 2020 (actual)
- Primary completion
- Apr 2024 (estimated)
- Study completion
- Apr 2024 (estimated)
- First posted
- 12 Nov 2020 (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.
The current study will use a full factorial design to identify the independent and combined effects of four core MABT components when combined with standard behavioral treatment for BN and BED. The primary aim of the study will be to evaluate the independent efficacy of Mindful Awareness, Distress Tolerance, Emotion Modulation, and Values-Based Decision Making on eating pathology (at posttreatment and at 6 and 12-month follow-ups). Secondary aims will be (1) to test target engagement of each MABT component, i.e., to confirm that each treatment component impacts both the variable which it targets and self-regulation and that improvements in these are associated with improvements in outcomes and (2) to test the hypotheses that the efficacy of each component is moderated by related baseline deficits in self-regulation (e.g. individuals with worse distress tolerance at baseline are most likely to benefit from conditions that include the Distress Tolerance component). A final exploratory aim will be to quantify the component interaction effects, which may be partially additive (because components overlap and/or there is diminishing return), fully additive, or synergistic (in that components may partially depend on each other).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (participant)
- Number of arms
- 16
- Model description
- MOST: multiphase optimization strategy
| Arm | Type | Receives |
|---|---|---|
| Base BT | Active comparator | Behavioral: Behavioral Therapy for Eating Disorders16 weekly sessions of behavioral therapy. |
| Base BT + Distress Tolerance | Experimental | Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with distress tolerance components of MABTs. |
| Base BT + Emotion Regulation | Experimental | Behavioral: MABT: Emotion Modulation16 weekly sessions of behavioral therapy with emotion regulation components of MABTs. |
| Base BT + Mindful Awareness | Experimental | Behavioral: MABT: Mindful Awareness16 weekly sessions of behavioral therapy with mindful awareness components of MABTs. |
| Base BT + Values | Experimental | Behavioral: MABT: Values16 weekly sessions of behavioral therapy with values components of MABTs. |
| Base BT + Distress Tolerance and Emotion Modulation | Experimental | Behavioral: MABT: Emotion Modulation, Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with emotion regulation and distress tolerance components of MABTs. |
| Base BT + Distress Tolerance and Mindful Awareness | Experimental | Behavioral: MABT: Mindful Awareness, Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with distress tolerance and mindful awareness components of MABTs. |
| Base BT + Distress Tolerance and Values | Experimental | Behavioral: MABT: Values, Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with distress tolerance and values components of MABTs. |
| Base BT + Emotion Modulation and Mindful Awareness | Experimental | Behavioral: MABT: Mindful Awareness, Behavioral: MABT: Emotion Modulation16 weekly sessions of behavioral therapy with emotion regulation and mindful awareness components of MABTs. |
| Base BT + Mindful Awareness and Values | Experimental | Behavioral: MABT: Mindful Awareness, Behavioral: MABT: Values16 weekly sessions of behavioral therapy with values and mindful awareness components of MABTs. |
| Base BT + Emotion Modulation and Values | Experimental | Behavioral: MABT: Values, Behavioral: MABT: Emotion Modulation16 weekly sessions of behavioral therapy with emotion regulation and values components of MABTs. |
| Base BT + EM, DT, MA | Experimental | Behavioral: MABT: Mindful Awareness, Behavioral: MABT: Emotion Modulation, Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and distress tolerance components of MABTs. |
| Base BT + DT, ER, and V | Experimental | Behavioral: MABT: Values, Behavioral: MABT: Emotion Modulation, Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with emotion regulation, distress tolerance, and values components of MABTs. |
| Base BT + DT, MA, and V | Experimental | Behavioral: MABT: Mindful Awareness, Behavioral: MABT: Values, Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with distress tolerance, mindful awareness, and values components of MABTs. |
| Base BT + ER, MA, and V | Experimental | Behavioral: MABT: Mindful Awareness, Behavioral: MABT: Values, Behavioral: MABT: Emotion Modulation16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, and values components of MABTs. |
| Base BT + ER, MA, V, DT | Experimental | Behavioral: MABT: Mindful Awareness, Behavioral: MABT: Values, Behavioral: MABT: Emotion Modulation, Behavioral: MABT: Distress Tolerance16 weekly sessions of behavioral therapy with emotion regulation, mindful awareness, distress tolerance, and values components of MABTs. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Have experienced 12 or more loss of control episodes within the previous 3 months
- Have a BMI above 16
- Are located in the US and wiling/able to participate in remote treatment and assessments
- Are able to give consent
Key exclusion criteria (5 listed)
- Are unable to fluently speak, write and read English
- Have a BMI below 16
- Are receiving treatment for an eating disorder
- Require immediate treatment for medical complications as a result of eating disorder symptoms
- Have a mental handicap, or are experiencing other severe psychopathology that would limit the participants' ability to comply with the demands of the current study (e.g. severe depression with suicidal intent, active psychotic disorder)
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 |
|---|---|---|
| Behavioral Therapy for Eating DisordersChange behaviors that maintain binge eating (e.g. rigid dietary restriction outside of binge episodes, irregular or chaotic eating patterns). | Behavioural | Base BT |
| MABT: Mindful AwarenessIntegrates behavioral treatment for eating disorders with a set of psychological strategies, specifically mindful awareness, designed to enhance self-regulation. Mindful awareness strategies include developing inner and outer wisdom, formal meditation, and shifting awareness to the present moment. Mindful awareness skills also include increasing awareness of thoughts, feelings, physical sensations, and hunger and fullness cues. | Behavioural | Base BT + DT, MA, and V, Base BT + Distress Tolerance and Mindful Awareness, Base BT + EM, DT, MA, Base BT + ER, MA, V, DT, Base BT + ER, MA, and V, Base BT + Emotion Modulation and Mindful Awareness, Base BT + Mindful Awareness, Base BT + Mindful Awareness and Values |
| MABT: ValuesIntegrates behavioral treatment for eating disorders with a set of psychological strategies, specifically values, designed to enhance self-regulation. Values skills include identifying and clarifying values, living a values life, making values-consistent decisions, addressing competing values, values awareness, and using values to address negative moods. | Behavioural | Base BT + DT, ER, and V, Base BT + DT, MA, and V, Base BT + Distress Tolerance and Values, Base BT + ER, MA, V, DT, Base BT + ER, MA, and V, Base BT + Emotion Modulation and Values, Base BT + Mindful Awareness and Values, Base BT + Values |
| MABT: Emotion ModulationIntegrates behavioral treatment for eating disorders with a set of psychological strategies, specifically emotion modulation, designed to enhance self-regulation. Emotion modulation skills include long-term habits for emotion regulation, coping strategies, crisis management, and cognitive reappraisal. | Behavioural | Base BT + DT, ER, and V, Base BT + Distress Tolerance and Emotion Modulation, Base BT + EM, DT, MA, Base BT + ER, MA, V, DT, Base BT + ER, MA, and V, Base BT + Emotion Modulation and Mindful Awareness, Base BT + Emotion Modulation and Values, Base BT + Emotion Regulation |
| MABT: Distress ToleranceIntegrates behavioral treatment for eating disorders with a set of psychological strategies, specifically distress tolerance, designed to enhance self-regulation. Distress tolerance skills include psychological acceptance, uncoupling, willingness, and dealing with dirty distress. | Behavioural | Base BT + DT, ER, and V, Base BT + DT, MA, and V, Base BT + Distress Tolerance, Base BT + Distress Tolerance and Emotion Modulation, Base BT + Distress Tolerance and Mindful Awareness, Base BT + Distress Tolerance and Values, Base BT + EM, DT, MA, Base BT + ER, MA, V, DT |
Primary outcome
Binge eating frequency assessed by the Eating Disorder Examination
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment
Frequency (number of days and number of instances) of binge eating over the past 28 days assessed by the Eating Disorder Examination
Eating Disorder Examination
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
The Eating Disorder Examination is a semi-structured interview that measures eating pathology. The EDE yields four subscale scores: Restraint, Eating Concern, Shape Concern, and Weight Concern. The possible score range for each subscale is 0 to 6. The total score may also be reported (determined by averaging the subscale scores); the score range for the total score is also 0 to 6. For subscale scores and total score, higher scores indicate more severe pathology. The restraint sub-scale of the EDE will be used to assess utilization of skills related to reducing dietary restraint.
Remission Status
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Presence or absence of eating disorder diagnosis. Not in remission; in partial remission; or in full remission.
2 secondary outcomes
Compensatory behavior frequency assessed by the Eating Disorder Examination (EDE)
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
BMI
Time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6 month and 1 year post-treatment follow-up assessment
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Sep 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Behavioral Therapy for Eating Disorders, MABT: Mindful Awareness and MABT: Values in people with Bulimia Nervosa and Bulimia; Atypical, run by Drexel University at 1 site 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 4 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: status not confirmed, as of the sponsor's last update on 25 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
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?
Binge eating frequency assessed by the Eating Disorder Examination (time frame: Changes from each assessment time point throughout treatment (3 assessments over 16 weeks) and 6-month and 1 year post-treatment follow-up assessment). 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?
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 25 Sep 2023.