Eating DisordersNCT00494858
Focused Versus Enhanced Cognitive Behavioral Therapy for Treating Women With Bulimia Nervosa
A study testing Cognitive behavioral therapy - focused (CBT-EF) and Cognitive behavioral therapy - broad (EB) in people with Eating Disorders, run by Boston University Charles River Campus at 1 site in United States.
Trial summary
This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Eating Disorders
- What is being tested?
- Cognitive behavioral therapy - focused (CBT-EF) and Cognitive behavioral therapy - broad (EB)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2007to Dec 2012
- 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 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Diagnosis of bulimia nervosa
- Presence of borderline personality disorder features
- History of one mood or anxiety episode within 2 years prior to study entry
- If taking psychiatric medication, dose has been stable for at least 6 weeks at time of study entry
Who cannot join
- Substance dependence
- Diagnosis of bipolar I disorder
- Psychosis
- Mental retardation
- Receiving psychosocial treatment
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Anxiety and Related Disorders, Boston University
Boston, Massachusetts, 02215
About this study
Official title: Treatment of Bulimia Nervosa: Dysregulated Subtype
This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.
Read the detailed description
Bulimia nervosa (BN) is a common eating disorder that is characterized by periods of bingeing and purging. People with the dysregulated subtype of BN experience behavioral impulsivity; disruption of cognitive, affective, behavioral, and neurophysiological processes (dysregulation); interpersonal dysfunction; and poor treatment response. To date, no therapies have been tested for this specific population, and it is unknown whether therapy that directly focuses on treating BN symptoms or one that addresses both eating and personality disorder symptoms is more effective. Cognitive behavioral therapy (CBT), which concentrates on modifying patients' behaviors and ways of thinking, has been effective in treating BN. This study will compare the effectiveness of two types of CBT, focused and broad, in treating adult women with the dysregulated subtype of BN.
Participants in this single-blind study will be randomly assigned to receive 20 sessions of either broad (enhanced) or focused CBT. Participants will meet with a therapist once or twice weekly until 20 sessions have occurred. Broad CBT will address symptoms of BN, as well as those of the personality disorder. Focused CBT will concentrate only on BN symptoms. Before treatment begins, participants will complete a set of questionnaires pertaining to their experiences with BN, depression, anxiety, and interpersonal relationships. The questionnaires will be used throughout the study to assess participants' progress. Participants will also attend a clinical interview lasting approximately 3.5 hours. Questions will concern BN, other eating disorder symptoms, depression, anxiety, and interpersonal relationships. Blood samples and vital signs will also be taken at the time of the clinical interview and as needed later in the treatment process.
- Conditions
- Eating Disorders
- Being tested
- Cognitive behavioral therapy - focused (CBT-EF), Cognitive behavioral therapy - broad (EB)
- Keywords
- Bulimia nervosa, Cognitive Behavioral Therapy, Personality Disorders
- Medical subject headings
- Feeding and Eating Disorders, Bulimia Nervosa, Personality Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive behavioral therapy - focused (CBT-EF)Behavioural
Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months.
Cognitive behavioral therapy - broad (EB)Behavioural
Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months.
| Study group | Role | What they receive |
|---|---|---|
| CBT-EF | Active comparator | Participants will receive cognitive behavioral therapy - focused Receives: Behavioral: Cognitive behavioral therapy - focused (CBT-EF) |
| CBT-EB | Experimental | Participants will receive cognitive behavioral therapy - broad Receives: Behavioral: Cognitive behavioral therapy - broad (EB) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating disorder symptoms
Measured: Measured throughout the study
Secondary outcomes (3)
Depression symptoms
Measured: Measured throughout the study
Anxiety symptoms
Measured: Measured throughout the study
Interpersonal relationships
Measured: Measured throughout the study
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jul 2007 (estimated)
- Study startJul 2007
- Primary completionDec 2012
- Study completionDec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Eating DisordersStudies 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
- None (open label)
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boston University Charles River Campus
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Heather Thompson-Brenner, PhD, Principal investigator, Center for Anxiety and Related Disorders, Boston University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00494858
- Sponsor's protocol ID
- K23MH071641
- Other IDs
- K23MH071641, DATR AK-TNAI2
- Status last verified
- Jul 2016
- First submitted
- 28 Jun 2007
- Last updated
- 20 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Bulimia Nervosa: Dysregulated Subtype
- ClinicalTrials.gov ID
- NCT00494858
- Acronym / sponsor ID
- K23MH071641
- Conditions
- Eating Disorders
- Keywords
- Bulimia nervosa, Cognitive Behavioral Therapy, Personality Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Boston University Charles River CampusUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Jul 2007
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 2 Jul 2007 (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.
This study will compare the effectiveness of two types of cognitive behavioral therapy in treating adult women with the dysregulated subtype of bulimia nervosa.
Detailed description
Bulimia nervosa (BN) is a common eating disorder that is characterized by periods of bingeing and purging. People with the dysregulated subtype of BN experience behavioral impulsivity; disruption of cognitive, affective, behavioral, and neurophysiological processes (dysregulation); interpersonal dysfunction; and poor treatment response. To date, no therapies have been tested for this specific population, and it is unknown whether therapy that directly focuses on treating BN symptoms or one that addresses both eating and personality disorder symptoms is more effective. Cognitive behavioral therapy (CBT), which concentrates on modifying patients' behaviors and ways of thinking, has been effective in treating BN. This study will compare the effectiveness of two types of CBT, focused and broad, in treating adult women with the dysregulated subtype of BN.
Participants in this single-blind study will be randomly assigned to receive 20 sessions of either broad (enhanced) or focused CBT. Participants will meet with a therapist once or twice weekly until 20 sessions have occurred. Broad CBT will address symptoms of BN, as well as those of the personality disorder. Focused CBT will concentrate only on BN symptoms. Before treatment begins, participants will complete a set of questionnaires pertaining to their experiences with BN, depression, anxiety, and interpersonal relationships. The questionnaires will be used throughout the study to assess participants' progress. Participants will also attend a clinical interview lasting approximately 3.5 hours. Questions will concern BN, other eating disorder symptoms, depression, anxiety, and interpersonal relationships. Blood samples and vital signs will also be taken at the time of the clinical interview and as needed later in the treatment process.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CBT-EF | Active comparator | Behavioral: Cognitive behavioral therapy - focused (CBT-EF)Participants will receive cognitive behavioral therapy - focused |
| CBT-EB | Experimental | Behavioral: Cognitive behavioral therapy - broad (EB)Participants will receive cognitive behavioral therapy - broad |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Diagnosis of bulimia nervosa
- Presence of borderline personality disorder features
- History of one mood or anxiety episode within 2 years prior to study entry
- If taking psychiatric medication, dose has been stable for at least 6 weeks at time of study entry
Key exclusion criteria (5 listed)
- Substance dependence
- Diagnosis of bipolar I disorder
- Psychosis
- Mental retardation
- Receiving psychosocial treatment
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 therapy - focused (CBT-EF)Focused CBT concentrates only on BN symptoms. There will be 20 sessions over the course of 5 months. | Behavioural | CBT-EF |
| Cognitive behavioral therapy - broad (EB)Broad CBT addresses symptoms of BN, as well as those of the personality disorder. CBT-EB incorporates ED interventions from CBT-EF but also has modules focused on addressing mood intolerance and interpersonal difficulties. There will be 20 sessions over 5 months. | Behavioural | CBT-EB |
Primary outcome
Eating disorder symptoms
Time frame: Measured throughout the study
3 secondary outcomes
Depression symptoms
Time frame: Measured throughout the study
Anxiety symptoms
Time frame: Measured throughout the study
Interpersonal relationships
Time frame: Measured throughout the study
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 Jul 2026.
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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.
Heather Thompson-Brenner, PhD principal investigator
Center for Anxiety and Related Disorders, Boston 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 Cognitive behavioral therapy - focused (CBT-EF) and Cognitive behavioral therapy - broad (EB) in people with Eating Disorders, run by Boston University Charles River Campus 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: finished, as of the sponsor's last update on 20 Jul 2026. 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?
Eating disorder symptoms (time frame: Measured throughout the study). 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 20 Jul 2026.