Binge-Eating DisorderNCT04076553
Augmenting Cognitive Behavioral Therapy With Inhibitory Control Training
A study testing CBT and ICT in people with Binge-Eating Disorder and Bulimia Nervosa, run by Drexel University at 1 site in United States.
Trial summary
The primary aim of this study is to determine whether a computerized inhibitory control training (ICT) will improve CBT treatment outcomes for Bulimia Nervosa and Binge Eating Disorder. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Binge-Eating Disorder, Bulimia Nervosa
- What is being tested?
- CBT and ICT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Oct 2019to Jul 2022
- 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 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age 18-55
- meet DSM-5 criteria for Bulimia Nervosa (i.e., at least one episode of binge eating and compensatory behavior per week on average for the past 3 months) or Binge Eating Disorder (i.e., at least one episode of binge eating per week on average for the past 3 months).
- be stable on psychiatric medications for at least 3 months
Who cannot join
- have a diagnosis of anorexia nervosa or a BMI < 18.5
- have extreme malnutrition or other medical complications that require acute hospitalization
- are at acute suicide risk
- are currently experiencing other severe psychopathology that would require a more intensive or specialized treatment program than the current study provides (e.g. severe depression, active psychotic disorder)
- have previously completed a trial of CBT for Bulimia Nervosa or Binge Eating Disorder
- have a diagnosis of an intellectual disability or autism spectrum disorder
- currently taking stimulant medications
- score of 95% or higher on 550ms block of Go/No-Go assessment task, indicating high inhibitory control at Baseline
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
Drexel University
Philadelphia, Pennsylvania, 19104
Lindsay Gillikin, BA, 215-553-7110, EDresearch@drexel.edu
About this study
Official title: Augmenting Cognitive Behavioral Therapy for Binge Eating Disorder and Bulimia Nervosa With Inhibitory Control Training
The primary aim of this study is to determine whether a computerized inhibitory control training (ICT) will improve CBT treatment outcomes for Bulimia Nervosa and Binge Eating Disorder.
Read the detailed description
This study involves a brief phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 12 sessions of CBT treatment and will be randomly assigned to an ICT or ICT sham condition which will consist of completing ICT computer tasks on a daily basis during the first four weeks of treatment and booster sessions following treatment. Participants will also complete research assessments at mid-treatment, post-treatment, and 3-month follow-up intervals. Research assessments include a battery of questionnaires, computerized tasks, interviews, and behavioral tasks.
- Conditions
- Binge-Eating Disorder, Bulimia Nervosa
- Being tested
- CBT, ICT
- Medical subject headings
- Binge-Eating Disorder, Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBTBehavioural
Participants will complete 12 sessions of CBT
ICTBehavioural
Participants will complete 4 weeks of daily inhibitory control trainings and "booster" ICT trainings following CBT treatment in weeks 5-12
| Study group | Role | What they receive |
|---|---|---|
| CBT + ICT | Active comparator | Participants randomized to the ICT condition will complete a computerized ICT training at home during the first 4 weeks of treatment and ICT "boosters" following their treatment sessions during weeks 5-12. Receives: Behavioral: CBT; Behavioral: ICT |
| CBT + sham | Sham comparator | Participants randomized to the sham condition will complete a computerized sham ICT training at home during the first 4 weeks of treatment and sham ICT "boosters" following their treatment sessions during weeks 5-12. The shame will contain the same proportion of food as non-food but no inhibitory training component. Receives: Behavioral: CBT |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination (EDE)
The Eating Disorder Examination is a widely utilized, semi-structured interview for the assessment of eating disorder symptoms and the binge-eating module will be used to determine binge episode frequency.
Measured: Change in binge frequency from baseline to post-treatment and 3-month follow-up
Secondary outcomes (1)
Food Frequency Questionnaire (FFQ)
A modified version of the Food Frequency Questionnaire will be used to examine changes in binge eating on specific foods in the last month
Measured: Change from baseline to post-treatment and 3-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 posted3 Sep 2019
- Study start15 Oct 2019
- Primary completionJul 2022 (estimated)
- Study completionJul 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Binge-Eating DisorderStudies 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
- Parallel groups
- Model description
- Participants will be randomly assigned to the ICT or ICT sham condition.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Drexel University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Stephanie Manasse, PhD, Principal investigator, Drexel University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04076553
- Sponsor's protocol ID
- 1904007136
- Status last verified
- Aug 2021
- First submitted
- 30 Aug 2019
- Last updated
- 9 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Butler RM, Lampe E, Trainor C, Manasse SM. Fear of weight gain during cognitive behavioral therapy for binge-spectrum eating disorders. Eat Weight Disord. 2023 Mar 6;28(1):29. doi: 10.1007/s40519-023-01541-8.
PubMed 36879078
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Augmenting Cognitive Behavioral Therapy for Binge Eating Disorder and Bulimia Nervosa With Inhibitory Control Training
- ClinicalTrials.gov ID
- NCT04076553
- Acronym / sponsor ID
- 1904007136
- Conditions
- Binge-Eating Disorder, Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Study start
- 15 Oct 2019 (actual)
- Primary completion
- Jul 2022 (estimated)
- Study completion
- Jul 2022 (estimated)
- First posted
- 3 Sep 2019 (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 primary aim of this study is to determine whether a computerized inhibitory control training (ICT) will improve CBT treatment outcomes for Bulimia Nervosa and Binge Eating Disorder.
Detailed description
This study involves a brief phone screen and baseline assessment to determine eligibility. Participants who are eligible for the study will receive 12 sessions of CBT treatment and will be randomly assigned to an ICT or ICT sham condition which will consist of completing ICT computer tasks on a daily basis during the first four weeks of treatment and booster sessions following treatment. Participants will also complete research assessments at mid-treatment, post-treatment, and 3-month follow-up intervals. Research assessments include a battery of questionnaires, computerized tasks, interviews, and behavioral tasks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants will be randomly assigned to the ICT or ICT sham condition.
| Arm | Type | Receives |
|---|---|---|
| CBT + ICT | Active comparator | Behavioral: CBT, Behavioral: ICTParticipants randomized to the ICT condition will complete a computerized ICT training at home during the first 4 weeks of treatment and ICT "boosters" following their treatment sessions during weeks 5-12. |
| CBT + sham | Sham comparator | Behavioral: CBTParticipants randomized to the sham condition will complete a computerized sham ICT training at home during the first 4 weeks of treatment and sham ICT "boosters" following their treatment sessions during weeks 5-12. The shame will contain the same proportion of food as non-food but no inhibitory training component. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-55
- meet DSM-5 criteria for Bulimia Nervosa (i.e., at least one episode of binge eating and compensatory behavior per week on average for the past 3 months) or Binge Eating Disorder (i.e., at least one episode of binge eating per week on average for the past 3 months).
- be stable on psychiatric medications for at least 3 months
Key exclusion criteria (8 listed)
- have a diagnosis of anorexia nervosa or a BMI < 18.5
- have extreme malnutrition or other medical complications that require acute hospitalization
- are at acute suicide risk
- are currently experiencing other severe psychopathology that would require a more intensive or specialized treatment program than the current study provides (e.g. severe depression, active psychotic disorder)
- have previously completed a trial of CBT for Bulimia Nervosa or Binge Eating 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 |
|---|---|---|
| CBTParticipants will complete 12 sessions of CBT | Behavioural | CBT + ICT, CBT + sham |
| ICTParticipants will complete 4 weeks of daily inhibitory control trainings and "booster" ICT trainings following CBT treatment in weeks 5-12 | Behavioural | CBT + ICT |
Primary outcome
Eating Disorder Examination (EDE)
Time frame: Change in binge frequency from baseline to post-treatment and 3-month follow-up
The Eating Disorder Examination is a widely utilized, semi-structured interview for the assessment of eating disorder symptoms and the binge-eating module will be used to determine binge episode frequency.
1 secondary outcome
Food Frequency Questionnaire (FFQ)
Time frame: Change from baseline to post-treatment and 3-month follow up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2021.
- Derived from this study: PubMed 36879078Butler RM, Lampe E, Trainor C, Manasse SM. Fear of weight gain during cognitive behavioral therapy for binge-spectrum eating disorders. Eat Weight Disord. 2023 Mar 6;28(1):29. doi: 10.1007/s40519-023-01541-8.
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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.
Stephanie Manasse, PhD principal investigator
Drexel University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing CBT and ICT in people with Binge-Eating Disorder and Bulimia Nervosa, 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 3 inclusion and 8 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 9 Aug 2021. 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. Some participants in this study may receive a placebo. 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?
Contact Lindsay Gillikin, BA (215-553-7110, EDresearch@drexel.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating Disorder Examination (EDE) (time frame: Change in binge frequency from baseline to post-treatment and 3-month follow-up). 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 NCT04076553, which also lists 1 linked publication.
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 9 Aug 2021.