Binge Eating DisorderNCT00848367
Binge Eating Disorder Treatment Study
A study testing Group Psychodynamic Interpersonal Psychotherapy in people with Binge Eating Disorder, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
The main objective of the proposed study is to determine whether the effectiveness of a group therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by optimally matching women with BED who have high attachment anxiety to Group Psychodynamic Interpersonal Psychotherapy (GPIP). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Group Psychodynamic Interpersonal Psychotherapy
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 102 participants
- Where
- 1 siteCanada
- Study dates
- Apr 2007to Dec 2011
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- •Overweight Women 18 years of age or older who binge eat at least twice per week for the past month.
Who cannot join
- unable speak English
- history of an eating disorder other than Binge Eating Disorder
- concurrent Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of bipolar disorder, psychosis, drug or alcohol problem
- pregnant or planning on becoming pregnant within the next year
- are currently or plan to become enrolled in a weight loss program within the next year
Trial locations and contacts
1 site in 1 country.
Canada1 site
Regional Centre for the Treatment of Eating Disorders
Ottawa, Ontario, K1H 8L6
About this study
Official title: Optimizing Outcomes for Binge Eating, Depression and Weight Loss for Obese Women With Binge Eating Disorder by Matching to Group Psychological Treatments Based on Level of Attachment Anxiety
The main objective of the proposed study is to determine whether the effectiveness of a group therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by optimally matching women with BED who have high attachment anxiety to Group Psychodynamic Interpersonal Psychotherapy (GPIP). This study represents the next phase in a program of research stemming from a previously conducted randomized controlled trial (RCT).
- Conditions
- Binge Eating Disorder
- Being tested
- Group Psychodynamic Interpersonal Psychotherapy
- Medical subject headings
- Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Group Psychodynamic Interpersonal PsychotherapyBehavioural
This intervention will consist of 16 weekly 90 minute sessions of Group Psychodynamic Interpersonal Psychotherapy (GPIP). GPIP was developed and empirically tested in a randomized controlled trial (RCT) at our Centre. GPIP will be preceded by an individual pre-group preparation session conducted by a psychologist trained in GPIP to orient the patient to the therapy. Patients are given a rationale for the treatment.
| Study group | Role | What they receive |
|---|---|---|
| High attachment anxiety condition | Experimental | 16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes. Receives: Behavioral: Group Psychodynamic Interpersonal Psychotherapy |
| Low attachment anxiety condition | Experimental | 16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes. Receives: Behavioral: Group Psychodynamic Interpersonal Psychotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Binge Eating in the Past 28 Days
Measured: Pre and Post treatment, 6 months and 1 year
Secondary outcomes (1)
Depression Symptoms
Early response to treatment is indicated by a reduction in depression symptoms measured by The Beck Depression Inventory II (BDI-II; Beck, Steer, \& Brown, 1996). The BDI-II is scored by summing the ratings for the 21 items. Each item is rated on a 4-point scale ranging from 0 to 3. The range for this scale is 0-63. Higher scores represent more depressive symptoms. We included cases that were missing up to 8 missing items and calculated scores for participants with missing items by taking the weighted mean and multiplying by 21.
Measured: Pre and Post treatment, 6 months and 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2009 (estimated)
- Study startApr 2007
- Primary completionSep 2010
- Study completionDec 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)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
- 102 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Responsible party
- Sponsor
- Investigators
- Giorgio Tasca, Ph.D.C.Psych, Principal investigator, University of Ottawa, Ottawa Hospital-General Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00848367
- Sponsor's protocol ID
- 2007254-01H
- Status last verified
- Jan 2014
- First submitted
- 19 Feb 2009
- Last updated
- 7 Feb 2014
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Tasca GA, Ritchie K, Demidenko N, Balfour L, Krysanski V, Weekes K, Barber A, Keating L, Bissada H. Matching women with binge eating disorder to group treatment based on attachment anxiety: outcomes and moderating effects. Psychother Res. 2013;23(3):301-14. doi: 10.1080/10503307.2012.717309. Epub 2012 Aug 24.
PubMed 22920044
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Outcomes for Binge Eating, Depression and Weight Loss for Obese Women With Binge Eating Disorder by Matching to Group Psychological Treatments Based on Level of Attachment Anxiety
- ClinicalTrials.gov ID
- NCT00848367
- Acronym / sponsor ID
- 2007254-01H
- Conditions
- Binge Eating Disorder
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 102 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Canadian Institutes of Health Research (CIHR)
- Study start
- Apr 2007
- Primary completion
- Sep 2010 (actual)
- Study completion
- Dec 2011 (actual)
- First posted
- 20 Feb 2009 (estimated)
- Results
- Posted 11 Dec 2013
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The main objective of the proposed study is to determine whether the effectiveness of a group therapy treatment for Binge Eating Disorder (BED) is improved and attrition reduced by optimally matching women with BED who have high attachment anxiety to Group Psychodynamic Interpersonal Psychotherapy (GPIP). This study represents the next phase in a program of research stemming from a previously conducted randomized controlled trial (RCT).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High attachment anxiety condition | Experimental | Behavioral: Group Psychodynamic Interpersonal Psychotherapy16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes. |
| Low attachment anxiety condition | Experimental | Behavioral: Group Psychodynamic Interpersonal Psychotherapy16 weeks of Group Psychodynamic Interpersonal Psychotherapy for patients with Binge Eating Disorder, matching them by attachment anxiety dimensions in order to enhance the impact of the therapy. It is hypothesized that by optimally matching patients to groups, they will have better clinical and health outcomes. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- •Overweight Women 18 years of age or older who binge eat at least twice per week for the past month.
Key exclusion criteria (5 listed)
- unable speak English
- history of an eating disorder other than Binge Eating Disorder
- concurrent Diagnostic and Statistical Manual-IV (DSM-IV) diagnosis of bipolar disorder, psychosis, drug or alcohol problem
- pregnant or planning on becoming pregnant within the next year
- are currently or plan to become enrolled in a weight loss program within the next year
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 |
|---|---|---|
| Group Psychodynamic Interpersonal PsychotherapyThis intervention will consist of 16 weekly 90 minute sessions of Group Psychodynamic Interpersonal Psychotherapy (GPIP). GPIP was developed and empirically tested in a randomized controlled trial (RCT) at our Centre. GPIP will be preceded by an individual pre-group preparation session conducted by a psychologist trained in GPIP to orient the patient to the therapy. Patients are given a rationale for the treatment. | Behavioural | High attachment anxiety condition, Low attachment anxiety condition |
Primary outcome
Frequency of Binge Eating in the Past 28 Days
Time frame: Pre and Post treatment, 6 months and 1 year
1 secondary outcome
Depression Symptoms
Time frame: Pre and Post treatment, 6 months and 1 year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Feb 2014.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22920044Tasca GA, Ritchie K, Demidenko N, Balfour L, Krysanski V, Weekes K, Barber A, Keating L, Bissada H. Matching women with binge eating disorder to group treatment based on attachment anxiety: outcomes and moderating effects. Psychother Res. 2013;23(3):301-14. doi: 10.1080/10503307.2012.717309. Epub 2012 Aug 24.
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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.
Giorgio Tasca, Ph.D.C.Psych principal investigator
University of Ottawa, Ottawa Hospital-General Campus
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Group Psychodynamic Interpersonal Psychotherapy in people with Binge Eating Disorder, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 1 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 7 Feb 2014. 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 Canada. 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?
Yes. Results are posted in the registry (first posted 11 Dec 2013). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 in the Past 28 Days (time frame: Pre and Post treatment, 6 months and 1 year). 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 NCT00848367, 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 Feb 2014.