Binge Eating DisorderNCT00965705
Stepped Care Treatment for Binge-Eating
A study testing Therapy in people with Binge Eating Disorder, run by Temple University at 1 site in United States.
Trial summary
Temple University is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder. Binge-Eating Disorder is a significant public health problem for women. Read more about this study
- Who is it for?
- Ages 18 to 60 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 109 participants
- Where
- 1 siteUnited States
- Study dates
- Jun 2009to Mar 2017
- 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 60 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Adult female, 18 years to 60 years
- Meets DSM-IV criteria for Binge Eating Disorder
- Resides within commuting distance
- Consents to research protocol, i.e.
- 18-24 months in assessment and treatment
- willing to be part of a biological assessment/physiological assessment
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- have to be prepared that they will receive a brief individual treatment and if this does not work for them, that they will receive more intensive treatment including both group and individual treatment.
- agreement not to see other health professionals unless recommended
- seeing their own Primary care Physician/Nurse Practitioner for medical screening prior to study (i.e., before being allocated a guided self-help therapist)
- payment for their own medical assessment, monitoring, and medication if needed
Who cannot join
- Anorexia nervosa
- Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS, or Bipolar Mood Disorder
- Needs priority treatment for other debilitating conditions, e.g. current substance dependence requiring inpatient detox
- chronic absence of shelter
- IQ less than 70
- Impending jail/prison, court order to treatment, court order to treatment or to jail, or agency order to treatment or to loss of child custody (due to consequent inability to freely drop-out of treatment)
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- Is pregnant, plans to become pregnant during treatment, or becomes pregnant before random assignment to study condition
- Medical instability
- Has had or is seeking Gastric bypass surgery
- On anti-seizure medication, beta-blockers, asthma medication, medication for heart disease, or any other medication that affects appetite or weight
- Psychotropics are acceptable if the doses are stable for at least 3 months prior to screening
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dialectical Behavior Therapy for Early Non-Responders to CBT
Temple University is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder.
Binge-Eating Disorder is a significant public health problem for women. Despite this, there is limited research on how best to treat this disorder at varying levels of severity. The purpose of this NIMH-funded study is to enroll individuals in a brief form of cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been adapted for women living with binge-eating disorder and are free of charge.
- Conditions
- Binge Eating Disorder
- Being tested
- Therapy
- Keywords
- Binge Eating Disorder, overeating, binge eating, women, overweight, compulsive overeating
- Medical subject headings
- Binge-Eating Disorder, Hyperphagia, Bulimia, Overweight
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TherapyBehavioural
Individual Therapy and Group Therapy
| Study group | Role | What they receive |
|---|---|---|
| Guided Self Help | Active comparator | Not described Receives: Behavioral: Therapy |
| Cognitive Behavioral Therapy | Active comparator | Not described Receives: Behavioral: Therapy |
| Dialectical Behavioral Therapy | Active comparator | Not described Receives: Behavioral: Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Measured: Up to 12 months after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2009 (estimated)
- Study startJun 2009
- Primary completionMar 2017
- Study completionMar 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)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
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 109 participants (actual)
Sponsor and investigators
- Lead sponsor
- Temple University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Eunice Chen, Temple University
- Investigators
- Eunice Y Chen, PHD, Principal investigator, Temple University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00965705
- Sponsor's protocol ID
- 20472
- Other IDs
- K23MH081030-01
- Status last verified
- Apr 2018
- First submitted
- 25 Aug 2009
- Last updated
- 20 Apr 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Chen EY, Cacioppo J, Fettich K, Gallop R, McCloskey MS, Olino T, Zeffiro TA. An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating. Psychol Med. 2017 Mar;47(4):703-717. doi: 10.1017/S0033291716002543. Epub 2016 Nov 17.
PubMed 27852348Southward MW, Christensen KA, Fettich KC, Weissman J, Berona J, Chen EY. Loneliness mediates the relationship between emotion dysregulation and bulimia nervosa/binge eating disorder psychopathology in a clinical sample. Eat Weight Disord. 2014 Dec;19(4):509-13. doi: 10.1007/s40519-013-0083-2.
PubMed 24235091
Study at a glance
From the registry record, last updated by the sponsor on 20 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dialectical Behavior Therapy for Early Non-Responders to CBT
- ClinicalTrials.gov ID
- NCT00965705
- Acronym / sponsor ID
- 20472
- Conditions
- Binge Eating Disorder
- Keywords
- Binge Eating Disorder, overeating, binge eating, women, overweight, compulsive overeating
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 109 participants (actual)
- Lead sponsor
- Temple UniversityUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jun 2009 (actual)
- Primary completion
- Mar 2017 (actual)
- Study completion
- Mar 2017 (actual)
- First posted
- 26 Aug 2009 (estimated)
- 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.
Temple University is looking for women to participate in a study to evaluate the treatment options available to women living with binge eating disorder.
Binge-Eating Disorder is a significant public health problem for women. Despite this, there is limited research on how best to treat this disorder at varying levels of severity. The purpose of this NIMH-funded study is to enroll individuals in a brief form of cognitive-behavior therapy. If more intense treatment is needed, individuals will be randomly assigned to more intensive group and individual treatments (Cognitive-Behavior Therapy or Dialectical Behavior Therapy). Both of these treatments are talking therapies that have been adapted for women living with binge-eating disorder and are free of charge.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Guided Self Help | Active comparator | Behavioral: Therapy |
| Cognitive Behavioral Therapy | Active comparator | Behavioral: Therapy |
| Dialectical Behavioral Therapy | Active comparator | Behavioral: Therapy |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (10 listed)
- Adult female, 18 years to 60 years
- Meets DSM-IV criteria for Binge Eating Disorder
- Resides within commuting distance
- Consents to research protocol, i.e.
- 18-24 months in assessment and treatment
Key exclusion criteria (11 listed)
- Anorexia nervosa
- Schizophrenia, Schizophreniform, or Schizoaffective Disorders, Psychosis NOS, or Bipolar Mood Disorder
- Needs priority treatment for other debilitating conditions, e.g. current substance dependence requiring inpatient detox
- chronic absence of shelter
- IQ less than 70
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 |
|---|---|---|
| TherapyIndividual Therapy and Group Therapy | Behavioural | Cognitive Behavioral Therapy, Dialectical Behavioral Therapy, Guided Self Help |
Primary outcome
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
Time frame: Up to 12 months after randomization
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month
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 20 Apr 2018.
- Results publication: PubMed 27852348Chen EY, Cacioppo J, Fettich K, Gallop R, McCloskey MS, Olino T, Zeffiro TA. An adaptive randomized trial of dialectical behavior therapy and cognitive behavior therapy for binge-eating. Psychol Med. 2017 Mar;47(4):703-717. doi: 10.1017/S0033291716002543. Epub 2016 Nov 17.
- Results publication: PubMed 24235091Southward MW, Christensen KA, Fettich KC, Weissman J, Berona J, Chen EY. Loneliness mediates the relationship between emotion dysregulation and bulimia nervosa/binge eating disorder psychopathology in a clinical sample. Eat Weight Disord. 2014 Dec;19(4):509-13. doi: 10.1007/s40519-013-0083-2.
- Temple University Eating Disorders (TED) WebsiteLink provided by the sponsor.
Related trials for Binge Eating Disorder
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Naltrexone Neuroimaging in Teens With Eating Disorders
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Eating Disorders
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.
Eunice Y Chen, PHD principal investigator
Temple 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 Therapy in people with Binge Eating Disorder, run by Temple 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 10 inclusion and 11 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 20 Apr 2018. 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?
Number of objective binge eating days or objective binge eating frequency using the Eating Disorders Examination-16 over the last month (time frame: Up to 12 months after randomization). 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 NCT00965705, which also lists 2 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 20 Apr 2018.