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

NCT01837953 | Unknown

• 1 other identifier: 20120689-01H
• Study Type: interventional
• Target: 150
• Locations: 1 country
• Sites: 1

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.

Conditions

Binge Eating Disorder

Outcome Measures

Primary Outcomes (1)

• 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).

  Up to one and a half years

Secondary Outcomes (14)

• Body Mass Index (BMI).

  Up to one and a half years

• Center for Epidemiologic Studies Depression Scale (CES-D)

  Up to one and a half years

• Experiences in Close Relationships Scale (ECR)

  Up to one and a half years

• Inventory of Interpersonal Problems (IIP-64)

  Up to one and a half years

• Patient Health Questionnaire 9 (PHQ-9).

  Up to one and a half years

Study Arms (2)

Unguided Self-Help, No Further Treatment for 16 Weeks

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.

Behavioral: Unguided Self-Help

Unguided Self-Help, GPIP

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.

Behavioral: Group Psychodynamic Interpersonal Psychotherapy; Behavioral: Unguided Self-Help

Interventions

Group Psychodynamic Interpersonal Psychotherapy BEHAVIORAL

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, GPIP

Unguided Self-Help BEHAVIORAL

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.

Unguided Self-Help, GPIP; Unguided Self-Help, No Further Treatment for 16 Weeks

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ottawa Hospital Research Institute: lead
• Ontario Mental Health Foundation: collaborator

Study Sites (1)

Regional Centre for the Treatment of Eating Disorders

Ottawa, Ontario, K1H8L6, Canada

Location

MeSH Terms

Conditions

Binge-Eating Disorder

Condition Hierarchy (Ancestors)

Feeding and Eating Disorders; Mental Disorders

Study Officials

• George A Tasca, Ph.D,C.Psych

  University of Ottawa, Ottawa Hospital: General Campus

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 28, 2013
• First Posted: April 23, 2013
• Study Start: November 1, 2012
• Primary Completion: September 1, 2016
• Study Completion: September 1, 2017
• Last Updated: October 4, 2016

Record last verified: 2016-10

Locations

CA (1)