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

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2013 by Ottawa Hospital Research Institute
Sponsor:
Collaborator:
Ontario Mental Health Foundation
Information provided by (Responsible Party):
Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier:
NCT01837953
First received: January 28, 2013
Last updated: April 18, 2013
Last verified: April 2013
  Purpose

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.


Condition Intervention
Binge Eating Disorder
Behavioral: Group Psychodynamic Interpersonal Psychotherapy
Behavioral: Unguided Self-Help

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial

Resource links provided by NLM:


Further study details as provided by Ottawa Hospital Research Institute:

Primary Outcome Measures:
  • Binge Eating Episodes in the Past 28 Days. [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    Binge eating is assessed in a structured interview using a calendar recall method (Wilfley et al., 1993).


Secondary Outcome Measures:
  • Body Mass Index (BMI). [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    This outcome variable will be calculated by dividing weight (kg) by height (m2).

  • Center for Epidemiologic Studies Depression Scale (CES-D) [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    The CES-D is a brief self-report measure of depressive symptoms.

  • Experiences in Close Relationships Scale (ECR) [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    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). [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    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 [ Time Frame: From the date of the start of unguided self-help to the end of self-help (Up to 10 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    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) [ Time Frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks) ] [ Designated as safety issue: No ]
    This is a self report measure of eating disorder symptoms including binge eating

  • 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) ] [ Designated as safety issue: No ]
    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) [ Time Frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks) ] [ Designated as safety issue: No ]
    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). [ Time Frame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to16 weeks) ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    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) [ Time Frame: Up to one and a half years ] [ Designated as safety issue: No ]
    The DASS-21 is a self-report measure of stress, anxiety, and depression.


Estimated Enrollment: 150
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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: 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.
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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01837953

Contacts
Contact: Nicole G Hammond, M.A. 6137985555 ext 73011 nhammond@toh.on.ca
Contact: Livia Chyurlia, M.Sc. 613-737-8059 lchyurlia@toh.on.ca

Locations
Canada, Ontario
Regional Centre for the Treatment of Eating Disorders Recruiting
Ottawa, Ontario, Canada, K1H8L6
Contact: Nicole G Hammond, M.A.    6137985555 ext 73011    nhammond@toh.on.ca   
Contact: Livia Chyurlia, M.Sc.    6137378059    lchyurlia@toh.on.ca   
Principal Investigator: George A Tasca, Ph.D,C.Psych         
Sponsors and Collaborators
Ottawa Hospital Research Institute
Ontario Mental Health Foundation
Investigators
Principal Investigator: George A Tasca, Ph.D,C.Psych University of Ottawa, Ottawa Hospital: General Campus
  More Information

Additional Information:
No publications provided

Responsible Party: Ottawa Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01837953     History of Changes
Other Study ID Numbers: 20120689-01H
Study First Received: January 28, 2013
Last Updated: April 18, 2013
Health Authority: Canada: Ethics Review Committee

Additional relevant MeSH terms:
Bulimia
Binge-Eating Disorder
Eating Disorders
Hyperphagia
Signs and Symptoms, Digestive
Signs and Symptoms
Mental Disorders

ClinicalTrials.gov processed this record on July 09, 2014