Rapid Response to Day Hospital Treatment in Bulimia Nervosa and Purging Disorder

NCT02444065 | Completed

• 1 other identifier: 14-7391-B
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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).

Conditions

Bulimia Nervosa; Eating Disorder

Keywords

Cognitive behavior therapy; Motivational interviewing; Bulimia nervosa; Rapid response

Outcome Measures

Primary Outcomes (2)

• Rapid response to 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

  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 Outcomes (2)

• End-of-Day Hospital Outcome

  Participants will be assessed at end of day hospital stay, an expected average of 8 weeks.

• 6-month relapse rate

  6 months after discharge from day hospital

Other Outcomes (7)

• Self-Efficacy

  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

  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

  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)

Study Arms (2)

Cognitive Behavior Therapy (CBT)

EXPERIMENTAL

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)

Motivational Interviewing (MI)

ACTIVE COMPARATOR

In this arm, participants receive the Motivational Interviewing intervention as an augmentative treatment to standard day hospital treatment as usual.

Behavioral: Motivational Interviewing (MI)

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.

Cognitive Behavior Therapy (CBT)

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.

Motivational Interviewing (MI)

Eligibility Criteria

• Age: 17 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Health Network, Toronto: lead
• Toronto Metropolitan University: collaborator

Study Sites (1)

Toronto General Hospital, Eating Disorder Program

Toronto, Ontario, M5G 2C4, Canada

Location

Related Publications (28)

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  PMID: 10910795 RESULT

• Bulik CM, Sullivan PF, Carter FA, McIntosh VV, Joyce PR. Predictors of rapid and sustained response to cognitive-behavioral therapy for bulimia nervosa. Int J Eat Disord. 1999 Sep;26(2):137-44. doi: 10.1002/(sici)1098-108x(199909)26:23.0.co;2-n.

  PMID: 10422602 RESULT

• Wilson GT, Fairburn CC, Agras WS, Walsh BT, Kraemer H. Cognitive-behavioral therapy for bulimia nervosa: time course and mechanisms of change. J Consult Clin Psychol. 2002 Apr;70(2):267-74.

  PMID: 11952185 RESULT

• Fairburn CG, Cooper Z, Doll HA, O'Connor ME, Bohn K, Hawker DM, Wales JA, Palmer RL. Transdiagnostic cognitive-behavioral therapy for patients with eating disorders: a two-site trial with 60-week follow-up. Am J Psychiatry. 2009 Mar;166(3):311-9. doi: 10.1176/appi.ajp.2008.08040608. Epub 2008 Dec 15.

  PMID: 19074978 RESULT

• Grilo CM, Masheb RM. Rapid response predicts binge eating and weight loss in binge eating disorder: findings from a controlled trial of orlistat with guided self-help cognitive behavioral therapy. Behav Res Ther. 2007 Nov;45(11):2537-50. doi: 10.1016/j.brat.2007.05.010. Epub 2007 Jun 7.

  PMID: 17659254 RESULT

• McFarlane TL, MacDonald DE, Royal S, Olmsted MP. Rapid and slow responders to eating disorder treatment: a comparison on clinically relevant variables. Int J Eat Disord. 2013 Sep;46(6):563-6. doi: 10.1002/eat.22136. Epub 2013 Apr 12.

  PMID: 23580395 RESULT

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  PMID: 23001832 RESULT

• MacDonald DE, Trottier K, McFarlane T, Olmsted MP. Empirically defining rapid response to intensive treatment to maximize prognostic utility for bulimia nervosa and purging disorder. Behav Res Ther. 2015 May;68:48-53. doi: 10.1016/j.brat.2015.03.007. Epub 2015 Mar 17.

  PMID: 25800137 RESULT

• Masheb RM, Grilo CM. Rapid response predicts treatment outcomes in binge eating disorder: implications for stepped care. J Consult Clin Psychol. 2007 Aug;75(4):639-44. doi: 10.1037/0022-006X.75.4.639.

  PMID: 17663617 RESULT

• McFarlane T, Olmsted MP, Trottier K. Timing and prediction of relapse in a transdiagnostic eating disorder sample. Int J Eat Disord. 2008 Nov;41(7):587-93. doi: 10.1002/eat.20550.

  PMID: 18473336 RESULT

• Olmsted MP, Kaplan AS, Rockert W. Rate and prediction of relapse in bulimia nervosa. Am J Psychiatry. 1994 May;151(5):738-43. doi: 10.1176/ajp.151.5.738.

  PMID: 8166317 RESULT

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  PMID: 8704727 RESULT

• Olmsted MP, MacDonald DE, McFarlane T, Trottier K, Colton P. Predictors of rapid relapse in bulimia nervosa. Int J Eat Disord. 2015 Apr;48(3):337-40. doi: 10.1002/eat.22380. Epub 2014 Dec 26.

  PMID: 25545720 RESULT

• Olmsted MP, McFarlane T, Trottier K, Rockert W. Efficacy and intensity of day hospital treatment for eating disorders. Psychother Res. 2013;23(3):277-86. doi: 10.1080/10503307.2012.721937. Epub 2012 Sep 18.

  PMID: 22989039 RESULT

• Raykos BC, Watson HJ, Fursland A, Byrne SM, Nathan P. Prognostic value of rapid response to enhanced cognitive behavioral therapy in a routine clinic sample of eating disorder outpatients. Int J Eat Disord. 2013 Dec;46(8):764-70. doi: 10.1002/eat.22169. Epub 2013 Aug 5.

  PMID: 23913536 RESULT

• Thompson-Brenner H, Shingleton RM, Sauer-Zavala S, Richards LK, Pratt EM. Multiple measures of rapid response as predictors of remission in cognitive behavior therapy for bulimia nervosa. Behav Res Ther. 2015 Jan;64:9-14. doi: 10.1016/j.brat.2014.11.004. Epub 2014 Nov 13.

  PMID: 25462877 RESULT

• Vaz AR, Conceicao E, Machado PP. Early response as a predictor of success in guided self-help treatment for bulimic disorders. Eur Eat Disord Rev. 2014 Jan;22(1):59-65. doi: 10.1002/erv.2262. Epub 2013 Oct 4.

  PMID: 24123526 RESULT

• Waller G. The myths of motivation: time for a fresh look at some received wisdom in the eating disorders? Int J Eat Disord. 2012 Jan;45(1):1-16. doi: 10.1002/eat.20900. Epub 2011 Feb 14.

  PMID: 22170018 RESULT

• Zunker C, Peterson CB, Cao L, Mitchell JE, Wonderlich SA, Crow S, Crosby RD. A receiver operator characteristics analysis of treatment outcome in binge eating disorder to identify patterns of rapid response. Behav Res Ther. 2010 Dec;48(12):1227-31. doi: 10.1016/j.brat.2010.08.007. Epub 2010 Sep 6.

  PMID: 20869041 RESULT

• Zeeck A, Weber S, Sandholz A, Wetzler-Burmeister E, Wirsching M, Hartmann A. Inpatient versus day clinic treatment for bulimia nervosa: a randomized trial. Psychother Psychosom. 2009;78(3):152-60. doi: 10.1159/000206869. Epub 2009 Mar 9.

  PMID: 19270470 RESULT

• Begin C, Gagnon-Girouard MP, Aime A, Ratte C. Trajectories of eating and clinical symptoms over the course of a day hospital program for eating disorders. Eat Disord. 2013;21(3):249-64. doi: 10.1080/10640266.2013.779188.

  PMID: 23600555 RESULT

• Byrne SM, Fursland A, Allen KL, Watson H. The effectiveness of enhanced cognitive behavioural therapy for eating disorders: an open trial. Behav Res Ther. 2011 Apr;49(4):219-26. doi: 10.1016/j.brat.2011.01.006. Epub 2011 Jan 27.

  PMID: 21345418 RESULT

• Horvath, A. O., & Greenberg, L. S. (1989). Development and validation of the Working Alliance Inventory. Journal of Counselling Psychology, 36, 223-233. doi:10.1037/0022-0167.36.2.223

  RESULT

• Beck, A. T., Steer, R. A., & Brown, G. K. (1996). Beck Depression Inventory-II. San Antonio, TX: Pearson.

  RESULT

• Gratz, K. L., & Roemer, L. (2004). Multidimensional assessment of emotion regulation and dysregulation: Development, factor structure, and initial validation of the Difficulties in Emotion Regulation Scale. Journal of Psychopathology and Behavioral Assessment, 26, 41-54. doi:10.1007/s10862-008-9102-4

  RESULT

• Geller J, Brown KE, Srikameswaran S, Piper W, Dunn EC. The psychometric properties of the Readiness and Motivation Questionnaire: a symptom-specific measure of readiness for change in the eating disorders. Psychol Assess. 2013 Sep;25(3):759-768. doi: 10.1037/a0032539. Epub 2013 May 6.

  PMID: 23647034 RESULT

• Trottier K, McFarlane T, Olmsted MP, McCabe RE. The Weight Influenced Self-Esteem Questionnaire (WISE-Q): factor structure and psychometric properties. Body Image. 2013 Jan;10(1):112-20. doi: 10.1016/j.bodyim.2012.08.008. Epub 2012 Oct 12.

  PMID: 23068567 RESULT

MeSH Terms

Conditions

Bulimia Nervosa; Feeding and Eating Disorders

Interventions

Cognitive Behavioral Therapy; Motivational Interviewing

Condition Hierarchy (Ancestors)

Mental Disorders; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Behavior Therapy; Psychotherapy; Behavioral Disciplines and Activities; Directive Counseling; Counseling; Mental Health Services; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Traci McFarlane, PhD

  University Health Network, Toronto

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 23, 2015
• First Posted: May 14, 2015
• Study Start: May 1, 2014
• Primary Completion: March 1, 2016
• Study Completion: March 1, 2016
• Last Updated: May 16, 2016

Record last verified: 2016-05

Locations

CA (1)