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Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

Primary Purpose

Eating Disorders, Anorexia Nervosa, Bulimia Nervosa

Status
Enrolling by invitation
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Self-compassionate letter-writing intervention
Sponsored by
University of Waterloo
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Eating Disorders

Eligibility Criteria

17 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Self-compassionate letter-writing intervention

Control condition

Arm Description

An online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks

Outcomes

Primary Outcome Measures

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).
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).
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).

Secondary Outcome Measures

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).
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).

Full Information

First Posted
November 4, 2019
Last Updated
September 21, 2023
Sponsor
University of Waterloo
Collaborators
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT04174703
Brief Title
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Official Title
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Enrolling by invitation
Study Start Date
September 29, 2020 (Actual)
Primary Completion Date
December 2024 (Anticipated)
Study Completion Date
December 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Waterloo
Collaborators
St. Joseph's Healthcare Hamilton

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Eating Disorders, Anorexia Nervosa, Bulimia Nervosa, Binge-Eating Disorder, Compassion

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
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.
Masking
Care Provider
Masking Description
The care providers will not be told which condition each participant was assigned to.
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Self-compassionate letter-writing intervention
Arm Type
Experimental
Arm Description
An online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks
Arm Title
Control condition
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
Self-compassionate letter-writing intervention
Intervention Description
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.
Primary Outcome Measure Information:
Title
Weight- and Body-Related Shame and Guilt Scale (WEB-SG)
Description
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).
Time Frame
Change from baseline to post-2 weeks of intervention/control condition
Title
Self-compassion Scale (short form; SCS-SF)
Description
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).
Time Frame
Change from baseline to post-2 weeks of intervention/control condition
Title
Readiness to Change Eating Behaviours
Description
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).
Time Frame
Change from baseline to post-2 weeks of intervention/control condition
Secondary Outcome Measure Information:
Title
Eating Disorder Examination Questionnaire (EDE-Q)
Description
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).
Time Frame
Change from day 1 to week 25 of group eating disorder treatment
Title
Clinical Impairment Assessment (CIA)
Description
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).
Time Frame
Change from day 1 to week 25 of group eating disorder treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Allison Kelly, PhD
Organizational Affiliation
University of Waterloo
Official's Role
Principal Investigator
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3K7
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
30102787
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.
Results Reference
background
PubMed Identifier
27237928
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.
Results Reference
background
PubMed Identifier
22917037
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.
Results Reference
background

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Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

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