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

NCT ID: NCT01837953

Last Updated: 2016-10-04

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 150 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-11-30
• Study Completion Date: 2017-09-30

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: OTHER

Unguided Self-Help

Intervention Type: 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

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 Type: EXPERIMENTAL

Group Psychodynamic Interpersonal Psychotherapy

Intervention Type: 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

Intervention Type: 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.

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Ontario Mental Health Foundation

OTHER_GOV

Sponsor Role: collaborator

Ottawa Hospital Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

George A Tasca, Ph.D,C.Psych

Role: PRINCIPAL_INVESTIGATOR

University of Ottawa, Ottawa Hospital: General Campus

Locations

Regional Centre for the Treatment of Eating Disorders

Ottawa, Ontario, Canada

Countries

Canada

Other Identifiers

20120689-01H

Identifier Type: -

Identifier Source: org_study_id