Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

Anorexia Nervosa Clinical Trial

Official title:

Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04174703
• Other study ID #: 41135
• Status: Enrolling by invitation
• Phase: N/A
• Start date: September 29, 2020
• Est. completion date: December 2024

Study information

• Verified date: September 2023
• Source: University of Waterloo
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Compassion-focused therapy (CFT) seeks to lower shame and help people develop compassion for personal distress and shortcomings. There is increasing evidence to support the benefits of incorporating CFT-based interventions into the treatment of eating disorders (EDs). Building on the investigators' prior research, this study will examine the effects of a two-week CFT-based self-compassion letter-writing intervention on patients with eating disorders. Participants will be recruited from the wait-list of patients scheduled to begin treatment at the outpatient St. Joseph's Healthcare Hamilton Eating Disorders Program, and will be randomly assigned to the two-week letter-writing intervention or to a control group. Results will inform the integration of new empirically-derived interventions into ED treatments to improve the currently dismal rates of ED recovery.

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.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 160
• Est. completion date: December 2024
• Est. primary completion date: December 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 17 Years and older

Eligibility

Inclusion Criteria:

1. DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder

2. Eligible to start group eating disorders treatment at St. Joseph's Eating Disorder Program

3. 17 years of age or older Exclusion Criteria: None

Related Conditions & MeSH terms

• Anorexia
• Anorexia Nervosa
• Binge-Eating Disorder
• Bulimia
• Bulimia Nervosa
• Compassion
• Eating Disorders
• Feeding and Eating Disorders

Intervention

Other:
• Self-compassionate letter-writing intervention
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.

Locations

Country	Name	City	State
Canada	St. Joseph's Healthcare Hamilton	Hamilton	Ontario

Sponsors (2)

Lead Sponsor	Collaborator
University of Waterloo	St. Joseph's Healthcare Hamilton

Country where clinical trial is conducted

Canada, 

References & Publications (3)

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Weight- and Body-Related Shame and Guilt Scale (WEB-SG)	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
Primary	Self-compassion Scale (short form; SCS-SF)	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
Primary	Readiness to Change Eating Behaviours	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).	Change from baseline to post-2 weeks of intervention/control condition
Secondary	Eating Disorder Examination Questionnaire (EDE-Q)	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
Secondary	Clinical Impairment Assessment (CIA)	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