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

O

Ottawa Hospital Research Institute

Status

Unknown

Conditions

Binge Eating Disorder

Treatments

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

Study type

Interventional

Funder types

Other

Identifiers

NCT01837953
20120689-01H

Details and patient eligibility

About

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.

Enrollment

150 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

150 participants in 2 patient groups

Unguided Self-Help, No Further Treatment for 16 Weeks
Other group
Description:
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.
Treatment:
Behavioral: Unguided Self-Help
Unguided Self-Help, GPIP
Experimental group
Description:
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.
Treatment:
Behavioral: Unguided Self-Help
Behavioral: Group Psychodynamic Interpersonal Psychotherapy

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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