Binge Eating DisorderNCT01837953
Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial
A study testing Group Psychodynamic Interpersonal Psychotherapy and Unguided Self-Help in people with Binge Eating Disorder, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Binge Eating Disorder (BED) affects as many as 3% of women and men in Ontario, 8% of obese individuals, and 30% to 50% of those participating in weight loss programs. BED, the most common eating disorder, is characterized by over-eating with loss of control (i.e., binge eating), but with no purging (e.g.… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Binge Eating Disorder
- What is being tested?
- Group Psychodynamic Interpersonal Psychotherapy and Unguided Self-Help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteCanada
- Study dates
- Nov 2012to Sep 2017
- 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
- Participants will be included if they:
- are comfortable speaking or reading English;
- do not have a history of an eating disorder other than BED, or a history of significant purging behaviour;
- do not have a concurrent DSM-IV diagnosis of bipolar disorder, psychosis, drug or alcohol dependence;
- are not currently or planning to be enrolled in a weight-loss program within the next year;
- are women who are not pregnant or planning to be pregnant within the next year; and
- are not currently or planning to be enrolled in other psychotherapies within the next year
Who cannot join
- Participants will be excluded if they:
- are not comfortable speaking or reading English;
- have a history of an eating disorder other than BED, or a history of significant purging behaviour;
- have a concurrent DSM-IV diagnosis of bipolar disorder, psychosis, drug or alcohol dependence;
- are currently or plan to be enrolled in a weight-loss program within the next year;
- are women who are pregnant or planning to be pregnant within the next year; and
- are currently or plan to be enrolled in other psychotherapies 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, K1H8L6
About this study
Binge Eating Disorder (BED) affects as many as 3% of women and men in Ontario, 8% of obese individuals, and 30% to 50% of those participating in weight loss programs. BED, the most common eating disorder, is characterized by over-eating with loss of control (i.e., binge eating), but with no purging (e.g., vomiting).Our previous research indicates that the total health care costs for women with BED is 36% higher than the Canadian average for women of a similar age, and that health care costs significantly decreased following intensive treatment at our Centre. The main goal of our study is to inform the development of a stepped care approach to the treatment of BED. Stepped care involves providing easily accessible low intensity treatment first, and then providing more expensive intensive treatment second, if necessary. The second goal is to assess if a second more intensive step of treatment provides added value. Although stepped care for BED is suggested by a number of clinicians and researchers, no study adequately tests predictors of who might benefit from minimal treatment alone and who would require the more intensive second step. The results of this study will guide decision making regarding who benefits from stepped care, and will help to increase the accessibility, availability, and cost effectiveness of psychological treatments for BED.
- Conditions
- Binge Eating Disorder
- Being tested
- Group Psychodynamic Interpersonal Psychotherapy, Unguided Self-Help
- 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
For those participants randomized to the USH + Group Psychodynamic Interpersonal Psychotherapy (GPIP) condition, this intervention will consist of 16 weekly 90 minute sessions of 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. Examples of the patient's cyclical relational patterns (CRPs) that may underlie their symptoms are discussed and the patient will be encouraged to work on these in the groups. Therapists will be given a written summary of each patient's CRP.
Unguided Self-HelpBehavioural
All participants will first receive 10 weeks of Unguided Self-help. The USH will be based on Dr. Christopher Fairburn's CBT-oriented and evidence based self-help treatment plan for binge eating explained in his book, Overcoming Binge Eating. The USH program follows six steps: (1) Getting Started: Self-monitoring, weekly weighing; (2) Regular Eating: Establishing a pattern of regular eating; (3) Alternatives to Binge Eating: Substituting alternative activities; (4) Problem Solving and Taking Stock: Practicing problem solving and reviewing progress; (5) Dieting and Related Forms of Avoidance: Tackling the three forms of dieting and other forms of avoidance eating; and (6) What Next? Preventing relapse and dealing with other problems.
| Study group | Role | What they receive |
|---|---|---|
| Unguided Self-Help, No Further Treatment for 16 Weeks | Other | All participants will first receive 10 weeks of unguided self-help (USH), followed by no further treatment for 16 weeks. Participants will be offered a follow up referral to the eating disorders program at The Ottawa Hospital after the 16 week no-treatment period. Receives: Behavioral: Unguided Self-Help |
| Unguided Self-Help, GPIP | Experimental | All participants will first receive 10 weeks of unguided self-help (USH). For those participants randomized to the USH + Group Psychodynamic Interpersonal Psychotherapy condition, this second step will consist of 16 weekly 90 minute sessions of Group Psychodynamic Interpersonal Psychotherapy. Receives: Behavioral: Group Psychodynamic Interpersonal Psychotherapy; Behavioral: Unguided Self-Help |
What is being measured
The primary outcome is the main question the study is designed to answer.
Binge Eating Episodes in the Past 28 Days.
Binge eating is assessed in a structured interview using a calendar recall method (Wilfley et al., 1993).
Measured: Up to one and a half years
Secondary outcomes (14)
Body Mass Index (BMI).
This outcome variable will be calculated by dividing weight (kg) by height (m2).
Measured: Up to one and a half years
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a brief self-report measure of depressive symptoms.
Measured: Up to one and a half years
Experiences in Close Relationships Scale (ECR)
The ECR, a predictor of USH outcome, is a 36-item measure comprising two 18-item scales (Avoidance and Anxiety). Items are scored on a 7-point Likert scale, ranging from 1 = Disagree Strongly to 7 = Agree Strongly.
Measured: Up to one and a half years
Inventory of Interpersonal Problems (IIP-64)
The IIP-64 assesses interpersonal problems; higher scores indicate greater problems. The IIP is a 64-item scale with a 5-point Likert-type response format.
Measured: Up to one and a half years
Patient Health Questionnaire 9 (PHQ-9).
The PHQ-9 is a 9-item self-report measure. The PHQ-9 is used in assessing the severity of depressive symptomology and can act as a diagnostic tool (Kroenke et al., 2001).
Measured: Up to one and a half years
Rapid Response to Treatment: Self-Monitoring
Self monitoring of binge eating is an indicator of rapid response to USH, which is a predictor of USH outcome. Daily record sheets will be used to assess objective binge eating episodes on an on-going basis throughout the course of USH. In each daily record, participants record whether they had any overeating behaviors (including objective binge episodes) and how many. The daily record forms provide a definition of objective binge episodes based on the EDE definition. These definitions will be reviewed with participants at the start of USH.
Measured: From the date of the start of unguided self-help to the end of self-help (Up to 10 weeks)
Rosenberg Self Esteem Scale (RSES)
The RSES, a predictor of USH outcome and an outcome variable, will be used to measure self esteem. The RSES is a ten-item self-report scale using a four-point response format. Scores are summed to produce a total score ranging from 0 to 30, with higher scores representing higher self esteem.
Measured: Up to one and a half years
Eating Disorder Diagnostic Scale (EDDS)
This is a self report measure of eating disorder symptoms including binge eating
Measured: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Experiences in Close Relationships Scale Short Form (ECR-S).
The ECR-S, a predictor of USH outcome, is a 12-item measure comprising two 6-item scales (Avoidance and Anxiety). Items are scored on a 7-point Likert scale, ranging from 1 = Disagree Strongly to 7 = Agree Strongly. The ECR-S was derived from the full ECR scale which was derived from existing self-report adult romantic attachment measures.
Measured: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Therapeutic Factors Inventory (TFI)
The full 99-item TFI will not be used in its entirety but rather the 9-item subscale of cohesiveness will only be used to measure levels of group cohesion throughout GPIP. It is a 7-point Likert-type scale with responses ranging from 1 (Strongly Disagree) to 7 (Strongly Agree).
Measured: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Outcome Rating Scale (ORS)
The ORS was originally developed as a shorter form of the Outcome Questionnaire 45.2 (Miller et al., 2003). The ORS is a 4-item self-report scale that will be used as a treatment outcome measure of GPIP.
Measured: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Working Alliance Inventory Short (WAI-S).
The WAI is a 12-item self-report measure of alliance to therapist and in this case the GPIP therapist.
Measured: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to16 weeks)
Eating Disorder Examination - Questionnaire (EDE-Q)
The EDE-Q, an outcome scale, is a 28-item self-report measure modeled on the EDE interview (Fairburn \& Cooper, 1993). The EDE-Q Restraint scale measures dietary restraint, Eating Concern scale measures concern about eating, Shape Concern scale measures preoccupation with one's body shape, and Weight Concern scale measures preoccupation with one's body weight (Fairburn \& Beglin, 1994)). The EDE-Q also provides a single overall score of eating disorder psychopathology based on the scales.
Measured: Up to one and a half years
Depression Anxiety and Stress Scales 21(DASS-21)
The DASS-21 is a self-report measure of stress, anxiety, and depression.
Measured: Up to one and a half years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Apr 2013 (estimated)
- Study startNov 2012
- Primary completionSep 2016
- Study completionSep 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge Eating DisorderStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe 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
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Responsible party
- Sponsor
- Investigators
- George A Tasca, Ph.D,C.Psych, Principal investigator, University of Ottawa, Ottawa Hospital: General Campus
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01837953
- Sponsor's protocol ID
- 20120689-01H
- Status last verified
- Oct 2016
- First submitted
- 28 Jan 2013
- Last updated
- 4 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT01837953
- Acronym / sponsor ID
- 20120689-01H
- Conditions
- Binge Eating Disorder
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Collaborators
- Ontario Mental Health Foundation
- Study start
- Nov 2012
- Primary completion
- Sep 2016 (actual)
- Study completion
- Sep 2017 (estimated)
- First posted
- 23 Apr 2013 (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.
Binge Eating Disorder (BED) affects as many as 3% of women and men in Ontario, 8% of obese individuals, and 30% to 50% of those participating in weight loss programs. BED, the most common eating disorder, is characterized by over-eating with loss of control (i.e., binge eating), but with no purging (e.g., vomiting).Our previous research indicates that the total health care costs for women with BED is 36% higher than the Canadian average for women of a similar age, and that health care costs significantly decreased following intensive treatment at our Centre. The main goal of our study is to inform the development of a stepped care approach to the treatment of BED. Stepped care involves providing easily accessible low intensity treatment first, and then providing more expensive intensive treatment second, if necessary. The second goal is to assess if a second more intensive step of treatment provides added value. Although stepped care for BED is suggested by a number of clinicians and researchers, no study adequately tests predictors of who might benefit from minimal treatment alone and who would require the more intensive second step. The results of this study will guide decision making regarding who benefits from stepped care, and will help to increase the accessibility, availability, and cost effectiveness of psychological treatments for BED.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Unguided Self-Help, No Further Treatment for 16 Weeks | Other | Behavioral: Unguided Self-HelpAll participants will first receive 10 weeks of unguided self-help (USH), followed by no further treatment for 16 weeks. Participants will be offered a follow up referral to the eating disorders program at The Ottawa Hospital after the 16 week no-treatment period. |
| Unguided Self-Help, GPIP | Experimental | Behavioral: Group Psychodynamic Interpersonal Psychotherapy, Behavioral: Unguided Self-HelpAll participants will first receive 10 weeks of unguided self-help (USH). For those participants randomized to the USH + Group Psychodynamic Interpersonal Psychotherapy condition, this second step will consist of 16 weekly 90 minute sessions of Group Psychodynamic Interpersonal Psychotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Participants will be included if they:
Key exclusion criteria (7 listed)
- Participants will be excluded if they:
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 PsychotherapyFor those participants randomized to the USH + Group Psychodynamic Interpersonal Psychotherapy (GPIP) condition, this intervention will consist of 16 weekly 90 minute sessions of 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. Examples of the patient's cyclical relational patterns (CRPs) that may underlie their symptoms are discussed and the patient will be encouraged to work on these in the groups. Therapists will be given a written summary of each patient's CRP. | Behavioural | Unguided Self-Help, GPIP |
| Unguided Self-HelpAll participants will first receive 10 weeks of Unguided Self-help. The USH will be based on Dr. Christopher Fairburn's CBT-oriented and evidence based self-help treatment plan for binge eating explained in his book, Overcoming Binge Eating. The USH program follows six steps: (1) Getting Started: Self-monitoring, weekly weighing; (2) Regular Eating: Establishing a pattern of regular eating; (3) Alternatives to Binge Eating: Substituting alternative activities; (4) Problem Solving and Taking Stock: Practicing problem solving and reviewing progress; (5) Dieting and Related Forms of Avoidance: Tackling the three forms of dieting and other forms of avoidance eating; and (6) What Next? Preventing relapse and dealing with other problems. | Behavioural | Unguided Self-Help, GPIP, Unguided Self-Help, No Further Treatment for 16 Weeks |
Primary outcome
Binge Eating Episodes in the Past 28 Days.
Time frame: Up to one and a half years
Binge eating is assessed in a structured interview using a calendar recall method (Wilfley et al., 1993).
14 secondary outcomes
Body Mass Index (BMI).
Time frame: Up to one and a half years
Center for Epidemiologic Studies Depression Scale (CES-D)
Time frame: Up to one and a half years
Experiences in Close Relationships Scale (ECR)
Time frame: Up to one and a half years
Inventory of Interpersonal Problems (IIP-64)
Time frame: Up to one and a half years
Patient Health Questionnaire 9 (PHQ-9).
Time frame: Up to one and a half years
Rapid Response to Treatment: Self-Monitoring
Time frame: From the date of the start of unguided self-help to the end of self-help (Up to 10 weeks)
Rosenberg Self Esteem Scale (RSES)
Time frame: Up to one and a half years
Eating Disorder Diagnostic Scale (EDDS)
Time frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Experiences in Close Relationships Scale Short Form (ECR-S).
Time frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Therapeutic Factors Inventory (TFI)
Time frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Outcome Rating Scale (ORS)
Time frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Working Alliance Inventory Short (WAI-S).
Time frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to16 weeks)
Eating Disorder Examination - Questionnaire (EDE-Q)
Time frame: Up to one and a half years
Depression Anxiety and Stress Scales 21(DASS-21)
Time frame: Up to one and a half years
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Oct 2016.
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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.
George A 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 and Unguided Self-Help 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 7 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: status not confirmed, as of the sponsor's last update on 4 Oct 2016. 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?
Results are not available in the source record.
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?
Binge Eating Episodes in the Past 28 Days. (time frame: Up to one and a half years). 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 4 Oct 2016.