- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04174703
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Study Overview
Status
Intervention / Treatment
Detailed Description
The study consists of two phases. In phase one, participants will be randomly assigned to a two-week daily letter-writing intervention condition or a two-week control condition; phase one will occur two to four weeks prior to the start date of group ED treatment. Participants will complete a brief set of online questionnaires pre-, mid-, and post- two-week condition (i.e. baseline, after one week, and after two weeks).
Following these two weeks of intervention/control condition, all participants will complete a 25-week group treatment program as scheduled by the Eating Disorders Program. For phase two of the study, participants will be asked to complete questionnaires after 5 weeks, after 11 weeks, and post-group treatment. Data that is routinely collected as part of patients' clinical care pre- and post-treatment (i.e. on the first day and last week of group treatment) will also be collected.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Ontario
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Hamilton, Ontario, Canada, L8N3K7
- St. Joseph's Healthcare Hamilton
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder
- Eligible to start group eating disorders treatment at St. Joseph's Eating Disorder Program
- 17 years of age or older
Exclusion Criteria: None
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
No Intervention: Control condition
|
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Experimental: Self-compassionate letter-writing intervention
An online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks
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Participants in this condition will be asked to engage in an online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Weight- and Body-Related Shame and Guilt Scale (WEB-SG)
Time Frame: Change from baseline to post-2 weeks of intervention/control condition
|
Self-report questionnaire with 12 questions on a 5-point Likert scale (scored 0-4).
Total scores range from 0-48, with higher decrease in score indicative of a better outcome (i.e. higher decrease in levels of shame and guilt).
|
Change from baseline to post-2 weeks of intervention/control condition
|
Self-compassion Scale (short form; SCS-SF)
Time Frame: Change from baseline to post-2 weeks of intervention/control condition
|
Self-report questionnaire with 12 questions on a 5-point Likert scale (scored 1-5).
Total scores range from 12-60, with higher increase in score indicative of a better outcome (i.e. higher increase in levels of self-compassion).
|
Change from baseline to post-2 weeks of intervention/control condition
|
Readiness to Change Eating Behaviours
Time Frame: Change from baseline to post-2 weeks of intervention/control condition
|
Self-report questionnaire with 3 questions on a 10-point Likert scale (scored 1-10).
Total scores range from 3-30, with higher increase in score indicative of a better outcome (i.e. higher increase in readiness to change disordered eating behaviours).
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Change from baseline to post-2 weeks of intervention/control condition
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Eating Disorder Examination Questionnaire (EDE-Q)
Time Frame: Change from day 1 to week 25 of group eating disorder treatment
|
Self-report questionnaire with 28 questions, collecting two types of data.
The EDE-Q collects frequency data of eating disorder behaviours.
The EDE-Q also has four subscales assessing the severity of four aspects of ED psychopathology.
These subscales are scored using 7-point Likert scales (scored 0-6).
Higher decreases in scores are indicative of a better outcome (i.e. higher decreases in eating disorder symptomatology).
|
Change from day 1 to week 25 of group eating disorder treatment
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Clinical Impairment Assessment (CIA)
Time Frame: Change from day 1 to week 25 of group eating disorder treatment
|
Self-report questionnaire with 16 questions on a 4-point Likert scale (scored 0-3).
Total scores range from 0-48, with higher decrease in score indicative of a better outcome (i.e. higher decrease in clinical impairment).
|
Change from day 1 to week 25 of group eating disorder treatment
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Allison Kelly, PhD, University of Waterloo
Publications and helpful links
General Publications
- Kelly AC, Waring SV. A feasibility study of a 2-week self-compassionate letter-writing intervention for nontreatment seeking individuals with typical and atypical anorexia nervosa. Int J Eat Disord. 2018 Aug;51(8):1005-1009. doi: 10.1002/eat.22930. Epub 2018 Aug 13.
- Kelly AC, Wisniewski L, Martin-Wagar C, Hoffman E. Group-Based Compassion-Focused Therapy as an Adjunct to Outpatient Treatment for Eating Disorders: A Pilot Randomized Controlled Trial. Clin Psychol Psychother. 2017 Mar;24(2):475-487. doi: 10.1002/cpp.2018. Epub 2016 May 30.
- Kelly AC, Carter JC, Zuroff DC, Borairi S. Self-compassion and fear of self-compassion interact to predict response to eating disorders treatment: a preliminary investigation. Psychother Res. 2013;23(3):252-64. doi: 10.1080/10503307.2012.717310. Epub 2012 Aug 24.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 41135
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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