Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial

October 3, 2016 updated by: Ottawa Hospital Research Institute
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 Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Unknown

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Anticipated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
150

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Ottawa, Ontario, Canada, K1H8L6
        • Regional Centre for the Treatment of Eating Disorders

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Participants will be included if they:

    1. are comfortable speaking or reading English;
    2. do not have a history of an eating disorder other than BED, or a history of significant purging behaviour;
    3. do not have a concurrent DSM-IV diagnosis of bipolar disorder, psychosis, drug or alcohol dependence;
    4. are not currently or planning to be enrolled in a weight-loss program within the next year;
    5. are women who are not pregnant or planning to be pregnant within the next year; and
    6. are not currently or planning to be enrolled in other psychotherapies within the next year

Exclusion Criteria:

  • Participants will be excluded if they:

    1. are not comfortable speaking or reading English;
    2. have a history of an eating disorder other than BED, or a history of significant purging behaviour;
    3. have a concurrent DSM-IV diagnosis of bipolar disorder, psychosis, drug or alcohol dependence;
    4. are currently or plan to be enrolled in a weight-loss program within the next year;
    5. are women who are pregnant or planning to be pregnant within the next year; and
    6. are currently or plan to be enrolled in other psychotherapies within the next year

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
OTHER: Unguided Self-Help, No Further Treatment for 16 Weeks
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.
Behavioral: Unguided Self-Help
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.
EXPERIMENTAL: Unguided Self-Help, GPIP
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.
Behavioral: Unguided Self-Help
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.
Behavioral: Group Psychodynamic Interpersonal Psychotherapy
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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Up to one and a half years

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Body Mass Index (BMI).
Time Frame: Up to one and a half years
This outcome variable will be calculated by dividing weight (kg) by height (m2).
Up to one and a half years
Center for Epidemiologic Studies Depression Scale (CES-D)
Time Frame: Up to one and a half years
The CES-D is a brief self-report measure of depressive symptoms.
Up to one and a half years
Experiences in Close Relationships Scale (ECR)
Time Frame: Up to one and a half years
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.
Up to one and a half years
Inventory of Interpersonal Problems (IIP-64)
Time Frame: Up to one and a half years
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.
Up to one and a half years
Patient Health Questionnaire 9 (PHQ-9).
Time Frame: Up to one and a half years
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).
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)
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.
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
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.
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)
This is a self report measure of eating disorder symptoms including binge eating
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)
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.
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)
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).
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)
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.
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)
The WAI is a 12-item self-report measure of alliance to therapist and in this case the GPIP therapist.
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
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.
Up to one and a half years
Depression Anxiety and Stress Scales 21(DASS-21)
Time Frame: Up to one and a half years
The DASS-21 is a self-report measure of stress, anxiety, and depression.
Up to one and a half years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ottawa Hospital Research Institute

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ontario Mental Health Foundation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: George A Tasca, Ph.D,C.Psych, University of Ottawa, Ottawa Hospital: General Campus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2012

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2016

Study Completion (ANTICIPATED)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 28, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 18, 2013

First Posted (ESTIMATE)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 23, 2013

Study Record Updates

Last Update Posted (ESTIMATE)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 4, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 3, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2016

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 20120689-01H

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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