Bulimia NervosaACQUIRENCT03673540
Acquisition and Utilization of Skills Using Innovative Smartphone Application for Regular Eating
A study testing CBT+ application in people with Bulimia Nervosa and Bulimia, run by Drexel University at 1 site in United States.
Trial summary
The study seeks to evaluate the acceptability, feasibility, target engagement, and validity of an innovative smartphone application with ecological momentary interventions to augment cognitive behavioral therapy for bulimia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Bulimia Nervosa, Bulimia, Binge Eating
- What is being tested?
- CBT+ application
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 61 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Aug 2018to 15 Jan 2021
- 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
- Meets criteria for bulimia nervosa or sub-threshold bulimia nervosa with subjective binge episodes (objective binge episodes or subjective binge episodes AND compensatory behaviors at least 1 time per week on average for the past 3 months)
- BMI >17.5
- Have a smartphone device
- Willing and able to use smartphone device to track food intake multiple times per day for 16 weeks
Who cannot join
- Pregnant or planning to become pregnant in the next year
- Currently experiencing severe psychopathology that would limit their ability to engage in study (e.g. suicidality, substance use disorder, psychotic disorder)
- Have previously received a full trial of CBT for bulimia nervosa
- History of bariatric surgery
Trial locations and contacts
1 site in 1 country.
United States1 site
Drexel University, Stratton Hall
Philadelphia, Pennsylvania, 19104
About this study
Official title: Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization
The study seeks to evaluate the acceptability, feasibility, target engagement, and validity of an innovative smartphone application with ecological momentary interventions to augment cognitive behavioral therapy for bulimia nervosa.
- Conditions
- Bulimia Nervosa, Bulimia, Binge Eating, Purging, Eating Disorder
- Being tested
- CBT+ application
- Keywords
- Bulimia Nervosa, Eating Disorder, Binge Eating, Bulimia, Purging
- Medical subject headings
- Bulimia Nervosa, Bulimia, Feeding and Eating Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CBT+ applicationBehavioural
Also called CBT+
Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions
| Study group | Role | What they receive |
|---|---|---|
| CBT with smartphone application (EMI on) | Experimental | CBT with CBT+ smartphone application (EMI on) Receives: Behavioral: CBT+ application |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge and purge frequency assessed by the Eating Disorder Examination
Frequency (number of days and number of instances) of binge eating and compensatory behaviors over the past 28 days assessed by the Eating Disorder Examination
Measured: Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment)
Secondary outcomes (4)
Eating Disorder Examination Questionnaire (EDE-Q)
The Eating Disorder Examination Questionnaire measures eating pathology. The EDE-Q 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-Q will be used to assess utilization of skills related to reducing dietary restraint.
Measured: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Difficulties in Emotion Regulation Scale (DERS)
The Difficulties in Emotion Regulation Scale is a self-report measure of emotional dysregulation. The DERS yields 6 subscale scores (Awareness, Clarity, Goals, Impulse, Nonacceptance, and Strategies) and a total score. The possible score range for each subscale is 3 to 15. The total score is computed by summing all 6 subscales, so the possible score range is 18 to 90. For all subscales and the total score, higher scores indicate greater difficulty in emotion regulation. The DERS will be used to assess utilization of skills related to increasing adaptive responses to cues.
Measured: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Technology Acceptance Model Scale (TAMS)
The Technology Acceptance Model Scale measures usefulness and ease of use of a technological product. The TAMS yields two subscale scores (usefulness and ease of use). The possible score range for each subscale is 6 to 49. Higher scores indicate greater usefulness and ease of use. The TAMS will be used to assess the perceived usefulness and perceived ease-of-use of the smartphone application to evaluate acceptability.
Measured: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Feedback Questionnaire (FQ)
The feedback questionnaire asks qualitative questions about the application. The feedback questionnaire does not report either subscale scores or a total score. The FQ will be used to obtain qualitative acceptability ratings.
Measured: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2018
- Study start31 Aug 2018
- Primary completion15 Jan 2021
- Study completion15 Jan 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 61 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
- NCT03673540
- Sponsor's protocol ID
- 1802006074
- Other IDs
- R34MH116021
- Acronym
- ACQUIRE
- Status last verified
- Sep 2021
- First submitted
- 12 Sep 2018
- Last updated
- 23 Sep 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Presseller EK, Wilkinson ML, Trainor C, Lampe EW, Juarascio AS. Self-regulation deficits moderate treatment outcomes in a clinical trial evaluating just-in-time adaptive interventions as an augmentation to cognitive-behavioral therapy for bulimia-spectrum eating disorders. Int J Eat Disord. 2022 May;55(5):709-716. doi: 10.1002/eat.23695. Epub 2022 Feb 24.
PubMed 35212017Presseller EK, Lampe EW, Michael ML, Trainor C, Fan SC, Juarascio AS. Latent trajectories of symptom change during cognitive-behavior therapy predict post-treatment worsening of symptoms: a preliminary examination among outpatients with bulimia-spectrum eating disorders. Eat Weight Disord. 2022 Aug;27(6):2257-2264. doi: 10.1007/s40519-021-01348-5. Epub 2022 Jan 4.
PubMed 34981464Parker MN, Wilkinson ML, Hunt RA, Ortiz A, Manasse SM, Juarascio AS. Eating expectancies and hedonic hunger among individuals with bulimia-spectrum eating disorders who plan binge-eating episodes. Int J Eat Disord. 2022 Jan;55(1):120-124. doi: 10.1002/eat.23628. Epub 2021 Oct 13.
PubMed 34643949
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Using Ecological Momentary Interventions to Increase Skill Acquisition and Utilization
- ClinicalTrials.gov ID
- NCT03673540
- Acronym / sponsor ID
- ACQUIRE / 1802006074
- Conditions
- Bulimia Nervosa, Bulimia, Binge Eating, Purging, Eating Disorder
- Keywords
- Bulimia Nervosa, Eating Disorder, Binge Eating, Bulimia, Purging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 61 participants (actual)
- Lead sponsor
- Drexel UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- 31 Aug 2018 (actual)
- Primary completion
- 15 Jan 2021 (actual)
- Study completion
- 15 Jan 2021 (actual)
- First posted
- 17 Sep 2018 (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 study seeks to evaluate the acceptability, feasibility, target engagement, and validity of an innovative smartphone application with ecological momentary interventions to augment cognitive behavioral therapy for bulimia nervosa.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| CBT with smartphone application (EMI on) | Experimental | Behavioral: CBT+ applicationCBT with CBT+ smartphone application (EMI on) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meets criteria for bulimia nervosa or sub-threshold bulimia nervosa with subjective binge episodes (objective binge episodes or subjective binge episodes AND compensatory behaviors at least 1 time per week on average for the past 3 months)
- BMI >17.5
- Have a smartphone device
- Willing and able to use smartphone device to track food intake multiple times per day for 16 weeks
Key exclusion criteria (4 listed)
- Pregnant or planning to become pregnant in the next year
- Currently experiencing severe psychopathology that would limit their ability to engage in study (e.g. suicidality, substance use disorder, psychotic disorder)
- Have previously received a full trial of CBT for bulimia nervosa
- History of bariatric surgery
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 |
|---|---|---|
| CBT+ applicationAlso: CBT+Smartphone application that comprises electronic self-monitoring of food intake, eating disorder behaviors, and mood and ecological momentary interventions | Behavioural | CBT with smartphone application (EMI on) |
Primary outcome
Binge and purge frequency assessed by the Eating Disorder Examination
Time frame: Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment)
Frequency (number of days and number of instances) of binge eating and compensatory behaviors over the past 28 days assessed by the Eating Disorder Examination
4 secondary outcomes
Eating Disorder Examination Questionnaire (EDE-Q)
Time frame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Difficulties in Emotion Regulation Scale (DERS)
Time frame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Technology Acceptance Model Scale (TAMS)
Time frame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
Feedback Questionnaire (FQ)
Time frame: Assessed at weekly treatment sessions throughout treatment duration (16 weeks)
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 23 Sep 2021.
- Derived from this study: PubMed 35212017Presseller EK, Wilkinson ML, Trainor C, Lampe EW, Juarascio AS. Self-regulation deficits moderate treatment outcomes in a clinical trial evaluating just-in-time adaptive interventions as an augmentation to cognitive-behavioral therapy for bulimia-spectrum eating disorders. Int J Eat Disord. 2022 May;55(5):709-716. doi: 10.1002/eat.23695. Epub 2022 Feb 24.
- Derived from this study: PubMed 34981464Presseller EK, Lampe EW, Michael ML, Trainor C, Fan SC, Juarascio AS. Latent trajectories of symptom change during cognitive-behavior therapy predict post-treatment worsening of symptoms: a preliminary examination among outpatients with bulimia-spectrum eating disorders. Eat Weight Disord. 2022 Aug;27(6):2257-2264. doi: 10.1007/s40519-021-01348-5. Epub 2022 Jan 4.
- Derived from this study: PubMed 34643949Parker MN, Wilkinson ML, Hunt RA, Ortiz A, Manasse SM, Juarascio AS. Eating expectancies and hedonic hunger among individuals with bulimia-spectrum eating disorders who plan binge-eating episodes. Int J Eat Disord. 2022 Jan;55(1):120-124. doi: 10.1002/eat.23628. Epub 2021 Oct 13.
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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 CBT+ application in people with Bulimia Nervosa and Bulimia, 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 4 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 23 Sep 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. 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?
Binge and purge frequency assessed by the Eating Disorder Examination (time frame: Change from baseline assessment (before beginning treatment) to post-treatment assessment (16 weeks after baseline assessment)). 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 NCT03673540, which also lists 3 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 23 Sep 2021.