Bulimia NervosaCBT4BNNCT00877786
Online Cognitive Behavioral Therapy for Bulimia Nervosa
A study testing Cognitive Behavioral Group Therapy in people with Bulimia Nervosa, run by University of North Carolina, Chapel Hill at 2 sites in United States.
Trial summary
Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN) is a research program funded by the National Institute of Mental Health and conducted by the UNC Eating Disorders Program and the University of Pittsburgh Medical Center. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- Cognitive Behavioral Group Therapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 196 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2008to May 2016
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV criteria for BN
- Internet access at home
- Either off psychotropic medication for at least one month or on a stable dose of psychotropic medication
Who cannot join
- Any major medical condition that would interfere with treatment or require alternative treatment
- Alcohol or drug dependence in the last three months
- Current significant suicidal ideation
- Developmental disability that would impair the ability to use the internet program effectively
- Psychosis, including schizophrenia, or bipolar I disorder
Trial locations and contacts
2 sites in 1 country.
United States2 sites
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27510
University of Pittsburgh
Pittsburgh, Pennsylvania, 15213
About this study
Official title: Optimizing Technology in the Treatment of Bulimia Nervosa
Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN) is a research program funded by the National Institute of Mental Health and conducted by the UNC Eating Disorders Program and the University of Pittsburgh Medical Center. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment and the gold-standard for treating bulimia nervosa. The current study aims to compare two forms of CBT: face-to-face group therapy and online group therapy via cbt4bn.org.
Read the detailed description
All treatment is conducted by trained professionals from either the UNC Eating Disorders Program (in Chapel Hill) or Western Psychiatric Institute (in Pittsburgh) who are experienced in the treatment of eating disorders.
Participants will participate in 16 1.5 hour long group sessions of group CBT over 20 weeks. Groups will include 5-8 participants, one or two co-therapists, and two sessions by a registered dietitian. Participants will be expected to complete self-monitoring forms which assess their mood and behavior. Groups will either take place face-to-face or online in a therapist-moderated chat group.
- Conditions
- Bulimia Nervosa
- Being tested
- Cognitive Behavioral Group Therapy
- Medical subject headings
- Bulimia Nervosa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive Behavioral Group TherapyBehavioural
Also called CBT, Cognitive Behavioral Therapy
Cognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors.
| Study group | Role | What they receive |
|---|---|---|
| Face-to-face group therapy | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Group Therapy |
| Online chat group therapy | Active comparator | Not described Receives: Behavioral: Cognitive Behavioral Group Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Abstinence from binge/purge episodes
Measured: 12 months
Secondary outcomes (2)
Reduction of binge/purge episodes
Measured: 12 months
Maintenance of behavior change
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Apr 2009 (estimated)
- Study startApr 2008
- Primary completionMay 2016
- Study completionMay 2016
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 Bulimia NervosaStudies of the same condition, open and under way.
- More trials run by University of North Carolina, Chapel HillThe 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 196 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of North Carolina, Chapel Hill
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Principal investigator, Cynthia Bulik, PhD, University of North Carolina, Chapel Hill
- Investigators
- Cynthia Bulik, PhD, Principal investigator, University of North Carolina, Chapel HillMarsha Marcus, PhD, Principal investigator, University of Pittsburgh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00877786
- Sponsor's protocol ID
- 07-2002
- Other IDs
- R01MH080065-01A1
- Acronym
- CBT4BN
- Status last verified
- Mar 2018
- First submitted
- 6 Apr 2009
- Last updated
- 29 Mar 2018
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Watson HJ, McLagan N, Zerwas SC, Crosby RD, Levine MD, Runfola CD, Peat CM, Moessner M, Zimmer B, Hofmeier SM, Hamer RM, Marcus MD, Bulik CM, Crow SJ. Cost-Effectiveness of Internet-Based Cognitive-Behavioral Treatment for Bulimia Nervosa: Results of a Randomized Controlled Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11314. doi: 10.4088/JCP.16m11314.
PubMed 29228517Levinson CA, Zerwas S, Calebs B, Forbush K, Kordy H, Watson H, Hofmeier S, Levine M, Crosby RD, Peat C, Runfola CD, Zimmer B, Moesner M, Marcus MD, Bulik CM. The core symptoms of bulimia nervosa, anxiety, and depression: A network analysis. J Abnorm Psychol. 2017 Apr;126(3):340-354. doi: 10.1037/abn0000254. Epub 2017 Mar 9.
PubMed 28277735
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Technology in the Treatment of Bulimia Nervosa
- ClinicalTrials.gov ID
- NCT00877786
- Acronym / sponsor ID
- CBT4BN / 07-2002
- Conditions
- Bulimia Nervosa
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 196 participants (actual)
- Lead sponsor
- University of North Carolina, Chapel HillUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Apr 2008
- Primary completion
- May 2016 (actual)
- Study completion
- May 2016 (actual)
- First posted
- 8 Apr 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.
Cognitive Behavioral Therapy for Bulimia Nervosa (CBT4BN) is a research program funded by the National Institute of Mental Health and conducted by the UNC Eating Disorders Program and the University of Pittsburgh Medical Center. Cognitive Behavioral Therapy (CBT) is an evidence-based treatment and the gold-standard for treating bulimia nervosa. The current study aims to compare two forms of CBT: face-to-face group therapy and online group therapy via cbt4bn.org.
Detailed description
All treatment is conducted by trained professionals from either the UNC Eating Disorders Program (in Chapel Hill) or Western Psychiatric Institute (in Pittsburgh) who are experienced in the treatment of eating disorders.
Participants will participate in 16 1.5 hour long group sessions of group CBT over 20 weeks. Groups will include 5-8 participants, one or two co-therapists, and two sessions by a registered dietitian. Participants will be expected to complete self-monitoring forms which assess their mood and behavior. Groups will either take place face-to-face or online in a therapist-moderated chat group.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Face-to-face group therapy | Active comparator | Behavioral: Cognitive Behavioral Group Therapy |
| Online chat group therapy | Active comparator | Behavioral: Cognitive Behavioral Group Therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- DSM-IV criteria for BN
- Internet access at home
- Either off psychotropic medication for at least one month or on a stable dose of psychotropic medication
Key exclusion criteria (5 listed)
- Any major medical condition that would interfere with treatment or require alternative treatment
- Alcohol or drug dependence in the last three months
- Current significant suicidal ideation
- Developmental disability that would impair the ability to use the internet program effectively
- Psychosis, including schizophrenia, or bipolar I 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 |
|---|---|---|
| Cognitive Behavioral Group TherapyAlso: CBT, Cognitive Behavioral TherapyCognitive behavioral therapy (CBT) is a form of psychotherapy that addresses the links between thoughts, emotions and behaviors. | Behavioural | Face-to-face group therapy, Online chat group therapy |
Primary outcome
Abstinence from binge/purge episodes
Time frame: 12 months
2 secondary outcomes
Reduction of binge/purge episodes
Time frame: 12 months
Maintenance of behavior change
Time frame: 12 months
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 29 Mar 2018.
- Derived from this study: PubMed 29228517Watson HJ, McLagan N, Zerwas SC, Crosby RD, Levine MD, Runfola CD, Peat CM, Moessner M, Zimmer B, Hofmeier SM, Hamer RM, Marcus MD, Bulik CM, Crow SJ. Cost-Effectiveness of Internet-Based Cognitive-Behavioral Treatment for Bulimia Nervosa: Results of a Randomized Controlled Trial. J Clin Psychiatry. 2018 Jan/Feb;79(1):16m11314. doi: 10.4088/JCP.16m11314.
- Derived from this study: PubMed 28277735Levinson CA, Zerwas S, Calebs B, Forbush K, Kordy H, Watson H, Hofmeier S, Levine M, Crosby RD, Peat C, Runfola CD, Zimmer B, Moesner M, Marcus MD, Bulik CM. The core symptoms of bulimia nervosa, anxiety, and depression: A network analysis. J Abnorm Psychol. 2017 Apr;126(3):340-354. doi: 10.1037/abn0000254. Epub 2017 Mar 9.
Related trials for Bulimia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Active, not recruiting
Targeting Social Function in Anxiety and Eating Disorders
Eating Disorders, Anorexia Nervosa
RecruitingObservational study
Children s Growth and Behavior Study
Obesity, Eating Behaviors
Not yet recruiting
Cognitive and Behavioral Approaches to Reduce Binge Eating and Excess Weight in Adolescents (Online)
Binge Eating, Overweight and Obesity
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.
Cynthia Bulik, PhD principal investigator
University of North Carolina, Chapel Hill
Marsha Marcus, PhD principal investigator
University of Pittsburgh
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Behavioral Group Therapy in people with Bulimia Nervosa, run by University of North Carolina, Chapel Hill 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 3 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 29 Mar 2018. 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?
Abstinence from binge/purge episodes (time frame: 12 months). 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 NCT00877786, 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 29 Mar 2018.