search
Back to results

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

Primary Purpose

Binge Eating Disorder

Status
Unknown status
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Group Psychodynamic Interpersonal Psychotherapy
Unguided Self-Help
Sponsored by
Ottawa Hospital Research Institute
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Binge Eating Disorder

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Regional Centre for the Treatment of Eating Disorders

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Experimental

Arm Label

Unguided Self-Help, No Further Treatment for 16 Weeks

Unguided Self-Help, GPIP

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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).

Secondary Outcome Measures

Body Mass Index (BMI).
This outcome variable will be calculated by dividing weight (kg) by height (m2).
Center for Epidemiologic Studies Depression Scale (CES-D)
The CES-D is a brief self-report measure of depressive symptoms.
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.
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.
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).
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.
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.
Eating Disorder Diagnostic Scale (EDDS)
This is a self report measure of eating disorder symptoms including binge eating
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.
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).
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.
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.
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.
Depression Anxiety and Stress Scales 21(DASS-21)
The DASS-21 is a self-report measure of stress, anxiety, and depression.

Full Information

First Posted
January 28, 2013
Last Updated
October 3, 2016
Sponsor
Ottawa Hospital Research Institute
Collaborators
Ontario Mental Health Foundation
search

1. Study Identification

Unique Protocol Identification Number
NCT01837953
Brief Title
Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial
Official Title
Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2012 (undefined)
Primary Completion Date
September 2016 (Actual)
Study Completion Date
September 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ottawa Hospital Research Institute
Collaborators
Ontario Mental Health Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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., 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge Eating Disorder

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
150 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Unguided Self-Help, No Further Treatment for 16 Weeks
Arm Type
Other
Arm Description
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.
Arm Title
Unguided Self-Help, GPIP
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Group Psychodynamic Interpersonal Psychotherapy
Intervention Description
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.
Intervention Type
Behavioral
Intervention Name(s)
Unguided Self-Help
Intervention Description
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.
Primary Outcome Measure Information:
Title
Binge Eating Episodes in the Past 28 Days.
Description
Binge eating is assessed in a structured interview using a calendar recall method (Wilfley et al., 1993).
Time Frame
Up to one and a half years
Secondary Outcome Measure Information:
Title
Body Mass Index (BMI).
Description
This outcome variable will be calculated by dividing weight (kg) by height (m2).
Time Frame
Up to one and a half years
Title
Center for Epidemiologic Studies Depression Scale (CES-D)
Description
The CES-D is a brief self-report measure of depressive symptoms.
Time Frame
Up to one and a half years
Title
Experiences in Close Relationships Scale (ECR)
Description
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.
Time Frame
Up to one and a half years
Title
Inventory of Interpersonal Problems (IIP-64)
Description
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.
Time Frame
Up to one and a half years
Title
Patient Health Questionnaire 9 (PHQ-9).
Description
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).
Time Frame
Up to one and a half years
Title
Rapid Response to Treatment: Self-Monitoring
Description
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.
Time Frame
From the date of the start of unguided self-help to the end of self-help (Up to 10 weeks)
Title
Rosenberg Self Esteem Scale (RSES)
Description
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.
Time Frame
Up to one and a half years
Title
Eating Disorder Diagnostic Scale (EDDS)
Description
This is a self report measure of eating disorder symptoms including binge eating
Time Frame
From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Title
Experiences in Close Relationships Scale Short Form (ECR-S).
Description
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.
Time Frame
From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Title
Therapeutic Factors Inventory (TFI)
Description
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).
Time Frame
From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Title
Outcome Rating Scale (ORS)
Description
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.
Time Frame
From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
Title
Working Alliance Inventory Short (WAI-S).
Description
The WAI is a 12-item self-report measure of alliance to therapist and in this case the GPIP therapist.
Time Frame
From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to16 weeks)
Title
Eating Disorder Examination - Questionnaire (EDE-Q)
Description
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.
Time Frame
Up to one and a half years
Title
Depression Anxiety and Stress Scales 21(DASS-21)
Description
The DASS-21 is a self-report measure of stress, anxiety, and depression.
Time Frame
Up to one and a half years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
George A Tasca, Ph.D,C.Psych
Organizational Affiliation
University of Ottawa, Ottawa Hospital: General Campus
Official's Role
Principal Investigator
Facility Information:
Facility Name
Regional Centre for the Treatment of Eating Disorders
City
Ottawa
State/Province
Ontario
ZIP/Postal Code
K1H8L6
Country
Canada

12. IPD Sharing Statement

Learn more about this trial

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

We'll reach out to this number within 24 hrs