Eating DisordersBESTNCT00158340
Guided Self-Help Treatment for Binge Eating Disorder
A study testing Guided self-help cognitive behavioral therapy (CBT) and Usual clinical care in people with Eating Disorders and Bulimia, run by Kaiser Permanente at 2 sites in United States.
Trial summary
This study will determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED). Read more about this study
- Who is it for?
- Ages 18 to 50 years
- Conditions the study is for
- Eating Disorders, Bulimia
- What is being tested?
- Guided self-help cognitive behavioral therapy (CBT) and Usual clinical care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 2 sitesUnited States
- Study dates
- Aug 2004to Jul 2008
- 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 50 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of binge eating disorder (BED) bulimia nervosa (BN), or spectrum BN, defined as recurrent binge eating at least once a week for 3 months
- Body mass index (BMI) between 18 and 45
- Continuous membership in the Kaiser Permanente Northwest Division for at least 12 months prior to study entry
Who cannot join
- Diagnosis of anorexia nervosa or psychotic disorder
- Significant organic brain syndromes, retardation, pervasive developmental disorder, or autism
- At risk for suicide
- Pregnancy
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Wesleyan University Department of Psychology
Middletown, Connecticut, 06459
Kaiser Permanente Center for Health Research
Portland, Oregon, 97227
About this study
Official title: Binge Eating Self-Guided Treatment (BEST)
This study will determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED).
Read the detailed description
Binge eating disorder (BED) is a serious condition characterized by compulsive overeating and feelings of powerlessness. The condition often has a negative impact on both physical and emotional health. This study will examine ways to help people determine whether they have BED and will test whether guided self-help (GSH) treatment is effective in treating BED.
Participants will be randomly assigned to receive either GSH treatment or usual clinical care (which may include general support and talk therapy) for 3 months. The GSH treatment is a cognitive behavioral therapy-based program that will be administered over 8 sessions. Participants receiving GSH will be given a book that focuses on dealing with BED; they will also meet with a therapist regularly to have their progress monitored. The Eating Disorders Examination (EDE), self-reports, questionnaires, and surveys will be used to assess participants. Assessments will be conducted at study entry, at Weeks 2 and 4 of the treatment, at the end of the treatment, and at 6 and 12 months post-treatment.
- Conditions
- Eating Disorders, Bulimia
- Being tested
- Guided self-help cognitive behavioral therapy (CBT), Usual clinical care
- Keywords
- Binge Eating, Overeating, Compulsive Eating, Hyperphagia
- Medical subject headings
- Feeding and Eating Disorders, Bulimia, Hyperphagia, Food Addiction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Guided self-help cognitive behavioral therapy (CBT)Behavioural
Participants receive eight sessions of guided self-help CBT.
Usual clinical careBehavioural
Control group participants receive treatment as usual.
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Participants will receive guided self-help cognitive behavioral therapy Receives: Behavioral: Guided self-help cognitive behavioral therapy (CBT) |
| 2 | Active comparator | Participants will receive treatment as usual Receives: Behavioral: Usual clinical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of binge eating
Measured: Measured at post-treatment, Week 12, Month 6, and Year 1
Secondary outcomes (2)
Frequency of inappropriate compensatory behaviors, dietary restraint, over-valuation of weight/shape, functional impairment, self-esteem, and social impairment
Measured: Measured at post-treatment, Week 12, Month 6, and Year 1
Body weight
Measured: Measured at post-treatmentand Year 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2005 (estimated)
- Study startAug 2004
- Primary completionJul 2008
- Study completionJul 2008
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Kaiser PermanenteThe 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
- None (open label)
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kaiser Permanente
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Responsible party
- Sponsor
- Investigators
- Ruth H. Striegel-Moore, PhD, Principal investigator, Wesleyan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00158340
- Sponsor's protocol ID
- R01MH066966
- Other IDs
- R01MH066966, DSIR 83-ATAS
- Acronym
- BEST
- Status last verified
- Nov 2011
- First submitted
- 7 Sep 2005
- Last updated
- 7 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Lynch FL, Striegel-Moore RH, Dickerson JF, Perrin N, Debar L, Wilson GT, Kraemer HC. Cost-effectiveness of guided self-help treatment for recurrent binge eating. J Consult Clin Psychol. 2010 Jun;78(3):322-33. doi: 10.1037/a0018982.
PubMed 20515208
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Binge Eating Self-Guided Treatment (BEST)
- ClinicalTrials.gov ID
- NCT00158340
- Acronym / sponsor ID
- BEST / R01MH066966
- Conditions
- Eating Disorders, Bulimia
- Keywords
- Binge Eating, Overeating, Compulsive Eating, Hyperphagia
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- Kaiser PermanenteUniversity, hospital or other
- Collaborators
- National Institute of Mental Health (NIMH)
- Study start
- Aug 2004
- Primary completion
- Jul 2008 (actual)
- Study completion
- Jul 2008 (actual)
- First posted
- 12 Sep 2005 (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 determine the effectiveness of guided self-help treatment in treating individuals with binge eating disorder (BED).
Detailed description
Binge eating disorder (BED) is a serious condition characterized by compulsive overeating and feelings of powerlessness. The condition often has a negative impact on both physical and emotional health. This study will examine ways to help people determine whether they have BED and will test whether guided self-help (GSH) treatment is effective in treating BED.
Participants will be randomly assigned to receive either GSH treatment or usual clinical care (which may include general support and talk therapy) for 3 months. The GSH treatment is a cognitive behavioral therapy-based program that will be administered over 8 sessions. Participants receiving GSH will be given a book that focuses on dealing with BED; they will also meet with a therapist regularly to have their progress monitored. The Eating Disorders Examination (EDE), self-reports, questionnaires, and surveys will be used to assess participants. Assessments will be conducted at study entry, at Weeks 2 and 4 of the treatment, at the end of the treatment, and at 6 and 12 months post-treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Guided self-help cognitive behavioral therapy (CBT)Participants will receive guided self-help cognitive behavioral therapy |
| 2 | Active comparator | Behavioral: Usual clinical careParticipants will receive treatment as usual |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Diagnosis of binge eating disorder (BED) bulimia nervosa (BN), or spectrum BN, defined as recurrent binge eating at least once a week for 3 months
- Body mass index (BMI) between 18 and 45
- Continuous membership in the Kaiser Permanente Northwest Division for at least 12 months prior to study entry
Key exclusion criteria (4 listed)
- Diagnosis of anorexia nervosa or psychotic disorder
- Significant organic brain syndromes, retardation, pervasive developmental disorder, or autism
- At risk for suicide
- Pregnancy
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 |
|---|---|---|
| Guided self-help cognitive behavioral therapy (CBT)Participants receive eight sessions of guided self-help CBT. | Behavioural | 1 |
| Usual clinical careControl group participants receive treatment as usual. | Behavioural | 2 |
Primary outcome
Frequency of binge eating
Time frame: Measured at post-treatment, Week 12, Month 6, and Year 1
2 secondary outcomes
Frequency of inappropriate compensatory behaviors, dietary restraint, over-valuation of weight/shape, functional impairment, self-esteem, and social impairment
Time frame: Measured at post-treatment, Week 12, Month 6, and Year 1
Body weight
Time frame: Measured at post-treatmentand Year 1
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 7 Nov 2011.
- Derived from this study: PubMed 20515208Lynch FL, Striegel-Moore RH, Dickerson JF, Perrin N, Debar L, Wilson GT, Kraemer HC. Cost-effectiveness of guided self-help treatment for recurrent binge eating. J Consult Clin Psychol. 2010 Jun;78(3):322-33. doi: 10.1037/a0018982.
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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.
Ruth H. Striegel-Moore, PhD principal investigator
Wesleyan University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Guided self-help cognitive behavioral therapy (CBT) and Usual clinical care in people with Eating Disorders and Bulimia, run by Kaiser Permanente 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 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 7 Nov 2011. 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?
Frequency of binge eating (time frame: Measured at post-treatment, Week 12, Month 6, and Year 1). 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 NCT00158340, which also lists 1 linked publication.
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 7 Nov 2011.