Clinical trial NCT01837953: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Binge Eating Disorder
Lead sponsor: Ottawa Hospital Research Institute
Sponsor class: OTHER
Collaborators: name: Ontario Mental Health Foundation
First posted: 2013-04-23
Enrollment: 150
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: Binge Eating Episodes in the Past 28 Days.
timeFrame: Up to one and a half years
Secondary outcomes:
measure: Body Mass Index (BMI).
timeFrame: Up to one and a half years
measure: Center for Epidemiologic Studies Depression Scale (CES-D)
timeFrame: Up to one and a half years
measure: Experiences in Close Relationships Scale (ECR)
timeFrame: Up to one and a half years
measure: Inventory of Interpersonal Problems (IIP-64)
timeFrame: Up to one and a half years
measure: Patient Health Questionnaire 9 (PHQ-9).
timeFrame: Up to one and a half years
measure: Rapid Response to Treatment: Self-Monitoring
timeFrame: From the date of the start of unguided self-help to the end of self-help (Up to 10 weeks)
measure: Rosenberg Self Esteem Scale (RSES)
timeFrame: Up to one and a half years
measure: Eating Disorder Diagnostic Scale (EDDS)
timeFrame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
measure: Experiences in Close Relationships Scale Short Form (ECR-S).
timeFrame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
measure: Therapeutic Factors Inventory (TFI)
timeFrame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
measure: Outcome Rating Scale (ORS)
timeFrame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to 16 weeks)
measure: Working Alliance Inventory Short (WAI-S).
timeFrame: From the start of Group Psychodynamic Interpersonal Psychotherapy (GPIP) to the end of GPIP (Up to16 weeks)
measure: Eating Disorder Examination - Questionnaire (EDE-Q)
timeFrame: Up to one and a half years
measure: Depression Anxiety and Stress Scales 21(DASS-21)
timeFrame: Up to one and a half years
Other outcomes:
Locations:
city: Ottawa
country: Canada
facility: Regional Centre for the Treatment of Eating Disorders
state: Ontario
Study officials:
affiliation: University of Ottawa, Ottawa Hospital: General Campus
name: George A Tasca, Ph.D,C.Psych
role: PRINCIPAL_INVESTIGATOR
References: