Clinical trial NCT03984539: Comparing CBT-T to CBT-E in Non-low-weight Adults With Eating Disorders
Official title: A Randomized Controlled Trial of the Effectiveness of CBT-T vs CBT-E in a Community Clinic of Individuals With Eating Disorders
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Eating Disorders
Lead sponsor: London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
Sponsor class: OTHER
Collaborators: name: University of Western Ontario, Canada
First posted: 2019-06-13
Enrollment: 60
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This study is a randomized controlled trial comparing the efficacy of two outpatient psychological treatments for eating disorders that primarily differ in length. Investigators will use a longitudinal design that includes both interview and questionnaire measures to assess eating disorder symptoms and other mental health-related outcomes.
Primary purpose: TREATMENT

Brief summary: Eating disorders are a difficult to treat illness with significant psychological and physical sequelae. Cognitive behavioural therapy (CBT) has been the most researched and supported intervention for eating disorders. A particular version of CBT for eating disorders, CBT-E (Fairburn, 2008), has been the focus of much research over the past decade. Despite promising results from initial CBT-E trials these findings have not always replicated well and evidence points to high drop-out in real-world settings. Further, CBT-E is a resource-intensive intervention, which may contribute to poorer access to care. In an attempt to overcome some of these barriers related to CBT-E, Waller and colleagues (2018) recently developed a brief (10 session) version of CBT for non-low-weight eating disorders (e.g., bulimia nervosa and binge eating disorder), referred to as CBT-T. Preliminary evidence from a case series of adult patients suggests that CBT-T has similar efficacy to CBT-E with low rates of drop-out. However, further evaluation of this brief treatment is needed, including direct comparisons with CBT-E. Indeed, given that no comparison group was included in the initial case series, it is unknown whether either CBT-T or CBT-E may be superior to the other. Thus, the aim of the current project is to examine CBT-T's efficacy in comparison to CBT-E as it has been implemented at the eating disorders service at London Health Science's Centre, and to determine whether either intervention is superior based on treatment outcome and treatment drop-out. Non-low-weight individuals with eating disorders assessed at the Adult Eating Disorders Service will be eligible to participate in the study. The principle investigator is Dr. Philip Masson, Ph.D., C. Psych., 519-685-8500 ext. 74866.

Detailed description: Design:

As CBT-T is anticipated to achieve faster improvement, due to its brief nature, than CBT-E this research study is not utilizing a non-inferiority design. That is, differences between the two interventions are anticipated, at least initially. Over time, the two interventions may become similar in some aspects (final remission rate for completers) but not others (final remission rate utilizing intention to treat).

Hypotheses:

CBT-T will produce higher rates of symptom abstinence initially as the treatment takes approximately half as long as CBT-E and then at post-treatment follow-ups that effect will disappear using completer analysis. However, as drop-out is expected to be lower in CBT-T it is expected that CBT-T will consistently produce superior results to CBT-E with intention to treat analysis.

Recruitment:

Individuals who have been assessed at the Adult Eating Disorders Service and meet eligibility criteria will be informed by the assessor that they are eligible to participate in a trial examining a new treatment. The assessor will provide the letter of information for the study and the study will be explained to the participants and any questions the participants have about the study will be addressed. The assessor will inform the staff psychometrist at the service that the participant is eligible to participate in the study. Participants will be asked to participate in the study once the participants name has reached the top of the treatment waitlist and a clinician is able to see them. Once the patient's name reaches the top of the treatment wait-list the participant will meet with the psychometrist in preparation for treatment, as part of routine procedure, and asked to participate in the study. Due to the significant waiting list (currently 5-6 months) as well as the tendency for some clients to end up not accessing care, study participation will be sought when it is most relevant.

At the beginning of client's appointments with the staff psychometrist, patients will be reminded of the study, provided information about the study and asked if to participate in the study. If they indicate interest in participating, then the psychometrist will thoroughly review the letter of information with patients. If patients agree to participate and sign the consent form, study measures will be given. The psychometrist will then inform the assigned therapist that the client wishes to participate in the study. To ensure the psychometrist is not aware of randomization, Philip Masson (study PI) will randomize the client to one of the two interventions using the website random.org. Philip Masson will inform the therapist of the randomization, and the therapist will then proceed with the appropriate treatment intervention. The PI will then keep track of randomization assignment in a separate excel file that the psychometrist does not have access to. If clients do not wish to participate in the study, clients will be assessed using the clinic's standard program evaluation protocol and will receive treatment as usual (CBT-E). Once individuals are participating in the study only the assigned treatment will be received and this process will be clearly explained to participants. Participants can withdraw from the study at any time at which point their data collection would stop; however, participants would continue to receive their assigned treatment. If participants wish to end treatment, then participants will be able to reapply to the service after a 2-month waiting period, which is standard practice for the service.

Interventions:

CBT-E is a transdiagnostic eating disorders treatment based on the principles of cognitive behavioural therapy which has been developed over the past 40 years. The treatment focusses on tracking and modifying eating behaviours, providing psychoeducation, addressing overvaluation of weight and shape, body image, food restriction and restraint, emotion regulation, and relapse prevention. For non-low-weight individuals, the treatment is designed as a 21 session treatment (one orientation meeting and 20 treatment sessions). The adult eating disorders service has been utilizing this treatment approach on an outpatient basis for the past two years. All staff members have reviewed the reading material associated with the treatment, participated in online training for CBT-E and participate in weekly peer supervisions sessions where staff members support one another in utilization of the treatment. Therapists are encouraged to review relevant sections of the therapist manual as needed. The treatment is adhered to the manual as close as possible except for one major exception. In CBT-E the treatment is designed to be delivered twice weekly for the first 4 hours. Instead, the service provides weekly sessions as the patients and staff found it too difficult to make twice weekly sessions fit into their schedule. After approximately 17 weekly sessions then sessions drop down to every other week.

CBT-T is a 10-session treatment based on cognitive behavioural therapy. It was developed based on clinical experience as well as core components of evidence-based versions of CBT for eating disorders, including CBT-E. The aim of the intervention is to provide only the hypothesized critical elements of CBT for eating disorders so that the interventions can be provided quicker. As rapid response to treatment in CBT for eating disorders has been shown to be a key predictor of outcome, it is possible that a briefer intervention may not be necessarily less effective. Further, briefer interventions may result in reduced drop-out which would allow more clients to fully access treatment. The key elements of this intervention are similar to CBT-E except there is a less explicit focus on emotion regulation and the psychoeducation is provided in the moment as opposed to being provided as a separate element of treatment. Further, in CBT-T treatment is initially only offered for four sessions and then extended only if the patient is actively engaging in treatment, which is similar to the session 8 progress review in CBT-E but occurs earlier and is framed differently. The therapy is delivered using a session by session checklist of core tasks to facilitate adherence. The clinicians at the service will receive training in CBT-T in the form of an 8-hour workshop delivered by one of the creators of the intervention, Glenn Waller. Further, the treatment manual will also be provided to all clinicians and read prior to the workshop. The clinicians will also participate in group supervision for one hour per week focusing on effective delivery of CBT-T.

Data Analysis:

Data will be analyzed using SPSS (version 24). Treatment groups will be compared on baseline characteristics (e.g., eating disorder symptoms) using independent samples t-tests and chi-square for categorical measures. Percentage scores will be calculated to determine attrition rates at each stage of treatment and chi-square analyses will be used to compare attrition/drop-out between the two treatment conditions. A two-level hierarchical linear model will be used to examine the influence of the intervention on change in symptoms over time. Level 1 (within-subjects) will include repeated measures of the dependent variable (e.g., EDE-Q scores, ED symptoms) and level 2 (between-subjects) will include treatment condition (CBT-T or CBT-E) and the interaction between condition and time. Separate models will be conducted for different outcome variables of interest. Both an intention to treat and completer analyses will be performed. For the intention to treat analysis multiple imputation will be utilized to handle the resultant missing data.

Power analyses: In accordance with recommendations for pilot RCTs by Rounsaville, Carroll, \& Onken (2001), the investigators aim to have at least 20 participants per group (after attrition). Based on power analyses for repeated measures analysis of variance (ANOVA) for between-within group differences using G\*power 3, a total sample size of 40 would yield \>80% power to detect medium effects (f2 \>.20), which represents a conservative approach, given increased power of multilevel modeling over traditional repeated measures ANOVA. Based on prior studies of CBT-T, the investigators anticipate an overall attrition rate of approximately 30%; thus, they propose to enroll 60 participants (30 per treatment condition) to detect an attrition-adjusted medium effect.

Eligibility criteria: Inclusion Criteria:

1. Non-underweight (BMI \> 19) adults (aged \> 17 years)
2. Diagnosis of bulimia nervosa (BN), binge eating disorder (BED), or otherwise specified feeding or eating disorder (e.g., subthreshold BN, subthreshold BED, purging disorder)

Exclusion Criteria:

1. Imminent risk for suicide
2. Profound cognitive impairment
3. Limited English language ability

Primary outcomes:
measure: Change in the frequency of Binge Eating
timeFrame: Will be assessed Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
measure: Change in the frequency of Vomiting
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E) 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
measure: Change in Eating Disorder Cognitions
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
Secondary outcomes:
measure: Binge Eating Change over the Course of Treatment
timeFrame: Pre-treatment and weekly while receiving treatment. Once a week for up to 10 weeks of treatment for CBT-T and up to 25 weeks of treatment for CBT-E.
measure: Vomiting Change over the Course of Treatment
timeFrame: Pre-treatment and weekly while receiving treatment. Once a week for up to 10 weeks of treatment for CBT-T and up to 25 weeks of treatment for CBT-E.
measure: Working Alliance change over the Course of Treatment
timeFrame: Pre-treatment and weekly while receiving treatment. Once a week for up to 10 weeks of treatment for CBT-T and up to 25 weeks of treatment for CBT-E.
measure: Change in Depression symptoms
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
measure: Change in anxiety symptoms
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
measure: Change in Loss of Control over Eating
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
measure: Change in Motivation
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
measure: Change in Impulsivity
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
measure: Change in overall perceived quality of life
timeFrame: Pre-Treatment; Post-Treatment (On average 10 weeks for CBT-T and 25 weeks for CBT-E), 3, 6, 12, 24 months post treatment. Treatment is on Average 10 weeks for CBT-T and 25 weeks for CBT-E
Other outcomes:
Locations:
city: London
country: Canada
facility: The Adult Eating Disorders Service
state: Ontario
Study officials:
affiliation: London Health Sciences Centre
name: Elizabeth Phoenix
role: PRINCIPAL_INVESTIGATOR
References:
citation: Berg KC, Peterson CB, Frazier P, Crow SJ. Psychometric evaluation of the eating disorder examination and eating disorder examination-questionnaire: a systematic review of the literature. Int J Eat Disord. 2012 Apr;45(3):428-38. doi: 10.1002/eat.20931. Epub 2011 Jul 8.
citation: Butler, A. C., Beck, A. T., & Cohen, L. H. (2007). The personality belief questionnaire-short form: Development and preliminary findings. Cognitive Therapy and Research, 31, 357-370. http://dx.doi.org/10.1007/s10608-006-9041-x
citation: 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.
citation: Cyders MA, Littlefield AK, Coffey S, Karyadi KA. Examination of a short English version of the UPPS-P Impulsive Behavior Scale. Addict Behav. 2014 Sep;39(9):1372-6. doi: 10.1016/j.addbeh.2014.02.013. Epub 2014 Mar 3.
citation: Dear BF, Titov N, Sunderland M, McMillan D, Anderson T, Lorian C, Robinson E. Psychometric comparison of the generalized anxiety disorder scale-7 and the Penn State Worry Questionnaire for measuring response during treatment of generalised anxiety disorder. Cogn Behav Ther. 2011;40(3):216-27. doi: 10.1080/16506073.2011.582138. Epub 2011 Jul 20.
citation: Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York, NY: Guilford.
citation: Fairburn, C. G., & Beglin, S. J. (2008) Eating Disorder Examination Questionnaire (6.0). In Fairburn CG. Cognitive Behavior Therapy and Eating Disorders. New York: Guilford Press.
citation: Fairburn, C. G., Cooper, Z., & O'Connor, M. (2008). Eating Disorder Examination (16.0D). In Fairburn C. G., Cognitive Behavior Therapy and Eating Disorders. New York: Guilford Press.
citation: 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.
citation: Faul F, Erdfelder E, Lang AG, Buchner A. G*Power 3: a flexible statistical power analysis program for the social, behavioral, and biomedical sciences. Behav Res Methods. 2007 May;39(2):175-91. doi: 10.3758/bf03193146.
citation: Faul F, Erdfelder E, Buchner A, Lang AG. Statistical power analyses using G*Power 3.1: tests for correlation and regression analyses. Behav Res Methods. 2009 Nov;41(4):1149-60. doi: 10.3758/BRM.41.4.1149.
citation: 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.
citation: Hatcher, R. L., & Gillaspy, J. A. (2006). Development and validation of a revised short version of the working alliance inventory. Psychotherapy Research, 16, 12-25. http://dx.doi.org/10.1080/10503300500352500
citation: Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
citation: Latner JD, Mond JM, Kelly MC, Haynes SN, Hay PJ. The Loss of Control Over Eating Scale: development and psychometric evaluation. Int J Eat Disord. 2014 Sep;47(6):647-59. doi: 10.1002/eat.22296. Epub 2014 May 26.
citation: Lowe B, Unutzer J, Callahan CM, Perkins AJ, Kroenke K. Monitoring depression treatment outcomes with the patient health questionnaire-9. Med Care. 2004 Dec;42(12):1194-201. doi: 10.1097/00005650-200412000-00006.
citation: Moriarty AS, Gilbody S, McMillan D, Manea L. Screening and case finding for major depressive disorder using the Patient Health Questionnaire (PHQ-9): a meta-analysis. Gen Hosp Psychiatry. 2015 Nov-Dec;37(6):567-76. doi: 10.1016/j.genhosppsych.2015.06.012. Epub 2015 Jun 18.
citation: Newman, M., Zuellig, A. R., Kachin, K. E., Constanitno, M. J., Przeworski, A., Erickson, T., & Cashman-McGrath, L. (2002). Preliminary reliability and validity of the generalized anxiety disorder questionnaire-IV: A revised self-report diagnostic measure of generalized anxiety disorder. Behavior Therapy, 33, 215-233. https://doi.org/10.1016/S0005-7894(02)80026-0
citation: 2024 exceptional surveillance of eating disorders: recognition and treatment (NICE guideline NG69) [Internet]. London: National Institute for Health and Care Excellence (NICE); 2024 May 15. No abstract available. Available from http://www.ncbi.nlm.nih.gov/books/NBK607987/
citation: Paap D, Dijkstra PU. Working Alliance Inventory-Short Form Revised. J Physiother. 2017 Apr;63(2):118. doi: 10.1016/j.jphys.2017.01.001. Epub 2017 Feb 21. No abstract available.
citation: Pellizzer ML, Waller G, Wade TD. Body image flexibility: A predictor and moderator of outcome in transdiagnostic outpatient eating disorder treatment. Int J Eat Disord. 2018 Apr;51(4):368-372. doi: 10.1002/eat.22842. Epub 2018 Feb 19.
citation: Rounsaville BJ, Carroll KM, Onken LS. A stage model of behavioral therapies research: Getting started and moving on from stage I. Clinical Psychology: Science and Practice. 2001;8(2):133-142.
citation: Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.
citation: Tatham M, Turner H, Mountford VA, Tritt A, Dyas R, Waller G. Development, psychometric properties and preliminary clinical validation of a brief, session-by-session measure of eating disorder cognitions and behaviors: The ED-15. Int J Eat Disord. 2015 Nov;48(7):1005-15. doi: 10.1002/eat.22430. Epub 2015 May 26.
citation: Turner H, Marshall E, Wood F, Stopa L, Waller G. CBT for eating disorders: The impact of early changes in eating pathology on later changes in personality pathology, anxiety and depression. Behav Res Ther. 2016 Feb;77:1-6. doi: 10.1016/j.brat.2015.11.011. Epub 2015 Dec 1.
citation: Waller G, Tatham M, Turner H, Mountford VA, Bennetts A, Bramwell K, Dodd J, Ingram L. A 10-session cognitive-behavioral therapy (CBT-T) for eating disorders: Outcomes from a case series of nonunderweight adult patients. Int J Eat Disord. 2018 Mar;51(3):262-269. doi: 10.1002/eat.22837. Epub 2018 Feb 8.
citation: Wonderlich SA, Peterson CB, Crosby RD, Smith TL, Klein MH, Mitchell JE, Crow SJ. A randomized controlled comparison of integrative cognitive-affective therapy (ICAT) and enhanced cognitive-behavioral therapy (CBT-E) for bulimia nervosa. Psychol Med. 2014 Feb;44(3):543-53. doi: 10.1017/S0033291713001098. Epub 2013 May 23.
citation: Development of the World Health Organization WHOQOL-BREF quality of life assessment. The WHOQOL Group. Psychol Med. 1998 May;28(3):551-8. doi: 10.1017/s0033291798006667.