Bulimia NervosaNCT00755391
Cognitive Behavioral Therapy for Adolescents With Bulimia
A study testing cognitive behavior therapy and Supportive Psychotherapy in people with Bulimia Nervosa, run by New York State Psychiatric Institute at 1 site in United States.
Trial summary
This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents. Read more about this study
- Who is it for?
- Ages 12 to 18 years
- Conditions the study is for
- Bulimia Nervosa
- What is being tested?
- cognitive behavior therapy and Supportive Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- Feb 2008to Feb 2010
- 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 12 to 18 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age between 12 and 18
- DSM-IV diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (binge eating and/or purging at least once per week)
Who cannot join
- Diagnosis of bipolar disorder
- Current psychosis
- Drug or alcohol abuse in the past 3 months
- Acute Suicidal Risk
- Major depression producing significant functional impairment
- Significant medical illness
- Weight outside of normal weight range (between 85% and 120% of the 50th percentile for age as measured by standard growth charts)
Trial locations and contacts
1 site in 1 country.
United States1 site
New York State Psychiatric Institute
New York, New York, 10032
About this study
This pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.
Read the detailed description
Patients will be randomized to have an equal chance of either receiving CBT or SP. Participants will include both individuals with DSM-IV bulimia nervosa (BN), and patients with sub-threshold BN. Adolescent patients will be treated at the New York State Psychiatric Institute, with a target recruitment of 20 patients completing the study. Participants in both conditions will be assessed prior to treatment and at the end of treatment. This trial is intended to serve as a pilot investigation to determine the feasibility and utility of a larger controlled study in this population.
- Conditions
- Bulimia Nervosa
- Being tested
- cognitive behavior therapy, Supportive Psychotherapy
- Keywords
- BN and subthreshold BN
- 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 behavior therapyBehavioural
The cognitive behavioral therapy used in this study will focus on developing patterns of regular eating, addressing body image issues, and ways to cope with situations that trigger eating disordered behaviors.
Supportive PsychotherapyBehavioural
The supportive psychotherapy treatment used in this study will involve identifying issues underlying your child's eating disorder and giving your child information about the psychological processes that tend to maintain or continue eating disorder symptoms.
| Study group | Role | What they receive |
|---|---|---|
| supportive psychotherapy | Placebo comparator | supportive psychotherapy: 14 sessions Receives: Behavioral: Supportive Psychotherapy |
| cognitive behavior therapy | Active comparator | cognitive behavior therapy: 14 sessions Receives: Behavioral: cognitive behavior therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Eating Disorder Examination scores
Measured: 28 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2008 (estimated)
- Study startFeb 2008
- Primary completionFeb 2010
- Study completionFeb 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York State Psychiatric Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robyn Sysko, PhD, Principal investigator, New York State Psychiatric Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00755391
- Sponsor's protocol ID
- 4819
- Status last verified
- Oct 2012
- First submitted
- 18 Sep 2008
- Last updated
- 26 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Behavioral Therapy for Adolescents With Bulimia
- ClinicalTrials.gov ID
- NCT00755391
- Acronym / sponsor ID
- 4819
- Conditions
- Bulimia Nervosa
- Keywords
- BN and subthreshold BN
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- New York State Psychiatric InstituteUniversity, hospital or other
- Study start
- Feb 2008
- Primary completion
- Feb 2010 (actual)
- Study completion
- Feb 2010 (actual)
- First posted
- 19 Sep 2008 (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 pilot study will evaluate the effectiveness of individual cognitive behavioral therapy (CBT) and supportive psychotherapy (SP) in reducing bulimic symptoms among adolescents.
Detailed description
Patients will be randomized to have an equal chance of either receiving CBT or SP. Participants will include both individuals with DSM-IV bulimia nervosa (BN), and patients with sub-threshold BN. Adolescent patients will be treated at the New York State Psychiatric Institute, with a target recruitment of 20 patients completing the study. Participants in both conditions will be assessed prior to treatment and at the end of treatment. This trial is intended to serve as a pilot investigation to determine the feasibility and utility of a larger controlled study in this population.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| supportive psychotherapy | Placebo comparator | Behavioral: Supportive Psychotherapysupportive psychotherapy: 14 sessions |
| cognitive behavior therapy | Active comparator | Behavioral: cognitive behavior therapycognitive behavior therapy: 14 sessions |
Who may qualify
- Ages
- 12 to 18 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Age between 12 and 18
- DSM-IV diagnosis of bulimia nervosa or sub-threshold bulimia nervosa (binge eating and/or purging at least once per week)
Key exclusion criteria (7 listed)
- Diagnosis of bipolar disorder
- Current psychosis
- Drug or alcohol abuse in the past 3 months
- Acute Suicidal Risk
- Major depression producing significant functional impairment
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 behavior therapyThe cognitive behavioral therapy used in this study will focus on developing patterns of regular eating, addressing body image issues, and ways to cope with situations that trigger eating disordered behaviors. | Behavioural | cognitive behavior therapy |
| Supportive PsychotherapyThe supportive psychotherapy treatment used in this study will involve identifying issues underlying your child's eating disorder and giving your child information about the psychological processes that tend to maintain or continue eating disorder symptoms. | Behavioural | supportive psychotherapy |
Primary outcome
Eating Disorder Examination scores
Time frame: 28 days
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 26 Oct 2012.
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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.
Robyn Sysko, PhD principal investigator
New York State Psychiatric Institute
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 behavior therapy and Supportive Psychotherapy in people with Bulimia Nervosa, run by New York State Psychiatric Institute 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 2 inclusion and 7 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 26 Oct 2012. 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?
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 Examination scores (time frame: 28 days). 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 26 Oct 2012.