CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Cognitive Behavior Therapy (CBT) +1 morebehavioral
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02444065
NCT02444065N/ACompleted

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

University Health Network, Toronto·interventional·Posted May 14, 2015·Updated May 16, 2016

In Brief

A clinical study evaluating Cognitive Behavior Therapy (CBT) and Motivational Interviewing (MI) for Bulimia Nervosa and Eating Disorder. Completed, enrolled 44 participants across 1 site.

Detailed 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).

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesCanada

Timeline

N/ACompletedFinished
2014201520162017201820192020202120222023202420252026
First PostedMay 14, 2015
Enrollment StartMay 1, 2014
Primary CompletionMar 1, 2016
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 11.1 years ago

Interventions

Cognitive Behavior Therapy (CBT)behavioral

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.

Motivational Interviewing (MI)behavioral

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.