Comparing CBT-T to CBT-E in Non-low-weight Adults With Eating Disorders
NCT ID: NCT03984539
Last Updated: 2022-05-20
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
NA
60 participants
INTERVENTIONAL
2021-06-15
2023-01-01
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
MICBT for Non-underweight Adults With Eating Disorders
NCT05503745
Personalized Treatment for Eating Disorders Versus CBT-E Trial
NCT05195840
Treatment of Binge Eating Disorder
NCT00039936
Treatment Outcome in Eating Disorders
NCT03599921
Trial on Three Eating Disorders Group Treatment
NCT05140109
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
CBT-E
Participants will be randomly assigned to one of two conditions (CBT-E or CBT-T). CBT-E will occur over the course of 25 weeks and be delivered as it typically is in the clinic setting of the investigators.
Cognitive Behavioural Therapy-Enhanced
CBT-E is a 20-session 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.
CBT-T
Participants will be randomly assigned to one of two conditions (CBT-E or CBT-T). Participants who agree to participate will receive 10 weeks of CBT-T.
Cognitive Behavioural Therapy-Ten
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.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Cognitive Behavioural Therapy-Enhanced
CBT-E is a 20-session 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.
Cognitive Behavioural Therapy-Ten
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.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
2. Profound cognitive impairment
3. Limited English language ability
17 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
University of Western Ontario, Canada
OTHER
London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Elizabeth Phoenix
Role: PRINCIPAL_INVESTIGATOR
London Health Sciences Centre
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Adult Eating Disorders Service
London, Ontario, Canada
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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
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.
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.
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.
Fairburn, C. G. (2008). Cognitive behavior therapy and eating disorders. New York, NY: Guilford.
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.
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.
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.
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.
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.
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.
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
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.
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.
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.
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.
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
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/
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
6278
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.