Clinical trial NCT02444065: Rapid Response to Day Hospital Treatment in Bulimia Nervosa and Purging Disorder
Official title: Rapid Response to Day Hospital Treatment in Bulimia Nervosa and Purging Disorder: A Randomized Controlled Trial of an Intervention to Facilitate Early Symptom Change
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bulimia Nervosa
Eating Disorder
Keywords: Cognitive behavior therapy
Motivational interviewing
Bulimia nervosa
Rapid response
Lead sponsor: University Health Network, Toronto
Sponsor class: OTHER
Collaborators: name: Toronto Metropolitan University
First posted: 2015-05-14
Enrollment: 44
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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).

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Rapid response to day hospital treatment
timeFrame: First 4 weeks of day hospital treatment
measure: Changes in bulimic symptom frequency
timeFrame: 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 outcomes:
measure: End-of-Day Hospital Outcome
timeFrame: Participants will be assessed at end of day hospital stay, an expected average of 8 weeks.
measure: 6-month relapse rate
timeFrame: 6 months after discharge from day hospital
Other outcomes:
measure: Self-Efficacy
timeFrame: 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)
measure: Motivation
timeFrame: 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)
measure: Hope
timeFrame: 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)
measure: Moderator of treatment response - emotion regulation
timeFrame: Baseline
measure: Moderator of treatment response - depression symptoms
timeFrame: Baseline
measure: Moderator of treatment response - weight-based self-esteem
timeFrame: Baseline
measure: Moderator of treatment response - working alliance with the therapist
timeFrame: Week 4
Locations:
city: Toronto
country: Canada
facility: Toronto General Hospital, Eating Disorder Program
state: Ontario
Study officials:
affiliation: University Health Network, Toronto
name: Traci McFarlane, PhD
role: PRINCIPAL_INVESTIGATOR
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