Rapid Response to Day Hospital Treatment in Bulimia Nervosa and Purging Disorder (CBT-RR)

May 13, 2016 updated by: University Health Network, Toronto

Rapid Response to Day Hospital Treatment in Bulimia Nervosa and Purging Disorder: A Randomized Controlled Trial of an Intervention to Facilitate Early Symptom Change

Treatments for bulimia nervosa (BN) have relatively high rates of nonremission and relapse, meaning that improving treatments is a high priority in this area. Rapid response to treatment -cessation of binge eating and vomiting symptoms within the first weeks of treatment - is a robust predictor of improved post-treatment outcomes and lower relapse rates, but no study has tried to facilitate rapid response as a means of improving treatment outcomes. The present study responds to this gap in the literature by testing a 4-session CBT-based individual intervention for rapid response (i.e., "CBT-RR"), designed to augment standard day hospital (DH) treatment for BN and Purging Disorder (PD) by focusing on strategies and skills for rapid symptom interruption. CBT-RR will be compared to a matched-intensity augmentative motivational interviewing (MI) intervention. Participants will be recruited from a hospital-based day program for eating disorders, and will be randomly assigned to one of the two conditions in addition to the DH as usual. participants will be assessed at pre-intervention, post-intervention, week 4 of DH, post-DH, and 6 months follow-up. It is hypothesized that compared to those who receive MI, patients who receive CBT-RR will be more likely to exhibit a rapid response to day hospital treatment (i.e., </= 3 binge eating and/or vomiting episodes in the first 4 weeks). It is further hypothesized that patients who receive CBT-RR will exhibit fewer binge eating and/or vomiting episodes at post-DH and at 6-month follow-up. Potential mediators and moderators of these hypothesized treatment effects will be examined on an exploratory basis, including self-efficacy, motivation, and hope (potential mediators), and emotion regulation, depression, cognitive psychopathology of eating disorders, and working alliance with the therapist (potential moderators).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Cognitive behaviour therapy (CBT) is the most empirically supported treatment for bulimia nervosa (BN) and related disorders, yet approximately 1/3 of completers do not remit, there is a substantial treatment attrition rate, and 1/3 of remitted patients will relapse within the first 2 years. Improving CBT is an important research prerogative. Motivational interviewing (MI) is an augmentative intervention that has been investigated to improve CBT, but reviews indicate that it is not efficacious with eating disorders. The failure of MI with eating disorders has led to consideration that focusing on early behaviour change might be a more productive therapeutic strategy. Rapid response to treatment for eating disorders has been reliably identified as a prognostic indicator in eating disorders. For BN and similar disorders, rapid response is the rapid reduction of binge eating, vomiting, and dietary restriction during the first few weeks of treatment. Numerous studies have indicated that patients who rapidly respond to treatment are significantly more likely to be remitted at post treatment and significantly less likely to relapse, compared to those who respond more slowly. No preexisting clinical, demographic, personality or other factors have clearly emerged to account for this effect. Given that rapid response has clear prognostic importance, and given that research has failed to identify mechanisms driving this finding, this study seeks to determine whether rapid response can be facilitated clinically using a targeted intervention designed to provide patients with specific behavioural skills to decrease their bulimic symptoms rapidly. Improving remission and relapse rates is a high priority in the eating disorders research field. the investigators already know that cognitive and behavioural strategies have efficacy for eating disorders, but existing treatments need improvement. Rapid response is an area that has been frequently described and has clear prognostic importance and no clear mechanism accounting for why some patients rapidly respond, suggesting that perhaps rapid response could be facilitated if patients are provided with the skills, mindset, and support to do so. However, no study to date has sought to answer this question and determine whether rapid response can be facilitated in order to improve patient prognoses. Thus, this study seeks to examine whether rapid response to day hospital treatment can be facilitated clinically using an augmentative CBT based intervention targeting early symptom change. The CBT intervention will be compared to a matched-intensity motivational interviewing (MI) intervention. The rationale for using MI is because MI is frequently used to augment standard treatments, it provides an active treatment comparison, and because the rationale for the present study emerged partly from research aimed at understanding some of the limitations of MI in treating eating disorders. Thus, MI provides a theoretically-driven comparison group. It is predicted that individuals who receive CBT (versus MI) will be more likely to be classified as rapid responders, and will have fewer bulimic symptoms at post-day hospital and 6-month follow-up. As well, it is hypothesized that changes in self-efficacy, motivation, or hopefulness may help to account for these findings.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
44

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2C4
        • Toronto General Hospital, Eating Disorder Program

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

13 years and older (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Diagnosis of bulimia nervosa or other specified feeding and eating disorder (OSFED) purging disorder
  • Body mass index of 19.0 or higher
  • Has accepted day hospital eating disorder treatment at the Toronto General Hospital Eating Disorder Day Hospital Program
  • No previous treatments at the Toronto General Hospital Eating Disorder Day Hospital Program in the previous 5 years
  • Can read and write English fluently.

Exclusion Criteria:

  • Current imminent suicidality
  • Current manic episode
  • Current psychosis
  • Current medical instability as assessed by program medical team.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Cognitive Behavior Therapy (CBT)
In this arm, participants receive the Cognitive behavior therapy (CBT) intervention as an augmentative treatment to standard day hospital treatment as usual.
Behavioral: Cognitive Behavior Therapy (CBT)
The CBT intervention is a 4 session (1 hour each) individual psychotherapy intervention that uses a manualized treatment protocol developed by the investigators. It uses standard CBT for eating disorders interventions, including orientation to the CBT model, psychoeducation, commitment and goal setting, behavioral strategies for normalizing eating and reducing bulimic symptoms, planning, and homework. 1-2 sessions are delivered before starting day hospital treatment, and the remaining sessions are delivered in the first weeks of day hospital.
Active Comparator: Motivational Interviewing (MI)
In this arm, participants receive the Motivational Interviewing intervention as an augmentative treatment to standard day hospital treatment as usual.
Behavioral: Motivational Interviewing (MI)
The MI intervention is a 4 session (1 hour each) individual psychotherapy intervention that uses a manualized treatment protocol (Carter & Bewell-Weiss, 2012). It uses standard MI for eating disorders interventions, including decisional balance, exploring values, readiness and confidence rules, and MI communication strategies. 1-2 sessions are delivered before starting day hospital treatment, and the remaining sessions are delivered in the first weeks of day hospital.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Rapid response to day hospital treatment
Time Frame: First 4 weeks of day hospital treatment
Rapid response is a binary outcome variable (yes/no) of early bulimic symptoms. Rapid responders exhibit a total of three or fewer binge and/or vomit and/or laxative episodes in the first four weeks of day hospital treatment for eating disorders.
First 4 weeks of day hospital treatment
Changes in bulimic symptom frequency
Time Frame: Each of the following: Baseline, first 4 weeks of day hospital, last 4 weeks of day hospital, and months 1-6 in follow-up.
Bulimic symptoms (binge eating and/or vomiting and/or laxative use) will be totalled for each 4 week period and changes modelled over time at the following time points: Baseline, first 4 weeks of day hospital, last 4 weeks of day hospital, and months 1-6 in follow-up.
Each of the following: Baseline, first 4 weeks of day hospital, last 4 weeks of day hospital, and months 1-6 in follow-up.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
End-of-Day Hospital Outcome
Time Frame: Participants will be assessed at end of day hospital stay, an expected average of 8 weeks.
Outcome is a binary outcome variable, remitted (yes/no). Remitted patients have one or fewer binge and/or vomit and/or laxative episodes in the last 4 weeks of day hospital treatment. Non-remitted patients have 2 or more episodes in this same period. Day hospital stays are expected to consist of an average of 8 weeks of treatment.
Participants will be assessed at end of day hospital stay, an expected average of 8 weeks.
6-month relapse rate
Time Frame: 6 months after discharge from day hospital
Relapse is a binary outcome variable (yes/no). Relapsed patients have an average of 4 or more binge and/or vomit and/or laxative use episodes per month for three consecutive months, beginning in the first 6 months after discharge from day hospital program. Non-relapsed patients have bulimic symptoms below this threshold.
6 months after discharge from day hospital

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Self-Efficacy
Time Frame: Each of the following: Baseline, Session 2 (on average the week before starting Day Hospital or Day Hospital week 1), Day Hospital Week 4, End of Day hospital (average=8 weeks)
Changes in self-efficacy will be modelled across several time points (baseline, session 2, week 4 of day hospital, and post-day hospital). Changes in self-efficacy from baseline to the 4th week in day hospital treatment will also be examined as a potential mediator of the effects of treatment on rapid response. Self-efficacy will be measured using the Readiness and Motivation Questionnaire (Geller et al., 2013). Day hospital stays are expected to consist of an average of 8 weeks of treatment.
Each of the following: Baseline, Session 2 (on average the week before starting Day Hospital or Day Hospital week 1), Day Hospital Week 4, End of Day hospital (average=8 weeks)
Motivation
Time Frame: Each of the following: Baseline, Session 2 (on average the week before starting Day Hospital or Day Hospital week 1), Day Hospital Week 4, End of Day hospital (average=8 weeks)
Changes in motivation will be modelled across several time points (baseline, session 2, week 4 of day hospital, and post-day hospital). Changes in motivation from baseline to the 4th week in day hospital treatment will also be examined as a potential mediator of the effects of treatment on rapid response. Motivation will be measured using the Readiness and Motivation Questionnaire (Geller et al., 2013). Day hospital stays are expected to consist of an average of 8 weeks of treatment.
Each of the following: Baseline, Session 2 (on average the week before starting Day Hospital or Day Hospital week 1), Day Hospital Week 4, End of Day hospital (average=8 weeks)
Hope
Time Frame: Each of the following: Baseline, Session 2 (on average the week before starting Day Hospital or Day Hospital week 1), Day Hospital Week 4, End of Day hospital (average=8 weeks)
Changes in hope will be modelled across several time points (baseline, session 2, week 4 of day hospital, and post-day hospital). Changes in hope from baseline to the 4th week in day hospital treatment will also be examined as a potential mediator of the effects of treatment on rapid response. Hope will be measured using an investigator-constructed questionnaire. Day hospital stays are expected to consist of an average of 8 weeks of treatment.
Each of the following: Baseline, Session 2 (on average the week before starting Day Hospital or Day Hospital week 1), Day Hospital Week 4, End of Day hospital (average=8 weeks)
Moderator of treatment response - emotion regulation
Time Frame: Baseline
Emotion regulation skills at baseline will be examined as a potential moderator of treatment response.
Baseline
Moderator of treatment response - depression symptoms
Time Frame: Baseline
Depression symptoms at baseline will be examined as a potential moderator of treatment response.
Baseline
Moderator of treatment response - weight-based self-esteem
Time Frame: Baseline
Weight-based self-esteem at baseline will be examined as a potential moderator of treatment response.
Baseline
Moderator of treatment response - working alliance with the therapist
Time Frame: Week 4
Working alliance with study therapist will be examined as a potential moderator of treatment response.
Week 4

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Health Network, Toronto

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Ryerson University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Traci McFarlane, PhD, University Health Network, Toronto

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2014

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
March 1, 2016

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2016

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 23, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2015

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 14, 2015

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 16, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 13, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 14-7391-B

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