Overview

This trial is active, not recruiting.

Condition binge eating disorder
Treatments group psychodynamic interpersonal psychotherapy, unguided self-help
Sponsor Ottawa Hospital Research Institute
Collaborator Ontario Mental Health Foundation
Start date November 2012
End date September 2016
Trial size 150 participants
Trial identifier NCT01837953, 20120689-01H

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification efficacy study
Intervention model parallel assignment
Masking open label
Primary purpose treatment
Arm
(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.
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)
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.
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.
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.

Primary Outcomes

Measure
Binge Eating Episodes in the Past 28 Days.
time frame: Up to one and a half years

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants at least 18 years old.

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

Additional Information

Official title Stepped Care for Binge Eating Disorder: Predicting Response to Minimal Intervention in a Randomized Controlled Trial
Principal investigator George A Tasca, Ph.D,C.Psych
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Ottawa Hospital Research Institute.