Clinical trial NCT04174703: Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Official title: Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Eating Disorders
Anorexia Nervosa
Bulimia Nervosa
Binge-Eating Disorder
Compassion
Lead sponsor: University of Waterloo
Sponsor class: OTHER
Collaborators: name: St. Joseph's Healthcare Hamilton
First posted: 2019-11-22
Enrollment: 160
Sex: ALL
Minimum age (years): 17
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Half of the study participants (n=80) will be placed into the self-compassionate letter-writing intervention group, and half of the study participants (n=80) will be placed into a control group.
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Weight- and Body-Related Shame and Guilt Scale (WEB-SG)
timeFrame: Change from baseline to post-2 weeks of intervention/control condition
measure: Self-compassion Scale (short form; SCS-SF)
timeFrame: Change from baseline to post-2 weeks of intervention/control condition
measure: Readiness to Change Eating Behaviours
timeFrame: Change from baseline to post-2 weeks of intervention/control condition
Secondary outcomes:
measure: Eating Disorder Examination Questionnaire (EDE-Q)
timeFrame: Change from day 1 to week 25 of group eating disorder treatment
measure: Clinical Impairment Assessment (CIA)
timeFrame: Change from day 1 to week 25 of group eating disorder treatment
Other outcomes:
Locations:
city: Hamilton
country: Canada
facility: St. Joseph's Healthcare Hamilton
state: Ontario
Study officials:
affiliation: University of Waterloo
name: Allison Kelly, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
citation: 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.