Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing

Sponsor
University of Waterloo (Other)
Overall Status
Enrolling by invitation
CT.gov ID
NCT04174703
Collaborator
St. Joseph's Healthcare Hamilton (Other)
160
1
2
21
7.6

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Other: Self-compassionate letter-writing intervention
N/A

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 Design

Study Type:
Interventional
Anticipated Enrollment :
160 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
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.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:
Single (Care Provider)
Masking Description:
The care providers will not be told which condition each participant was assigned to.
Primary Purpose:
Treatment
Official Title:
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Actual Study Start Date :
Sep 29, 2020
Anticipated Primary Completion Date :
Jul 1, 2022
Anticipated Study Completion Date :
Jul 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Self-compassionate letter-writing intervention

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

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.

No Intervention: Control condition

Outcome Measures

Primary Outcome Measures

  1. Weight- and Body-Related Shame and Guilt Scale (WEB-SG) [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).

  2. Self-compassion Scale (short form; SCS-SF) [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).

  3. Readiness to Change Eating Behaviours [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).

Secondary Outcome Measures

  1. Eating Disorder Examination Questionnaire (EDE-Q) [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).

  2. Clinical Impairment Assessment (CIA) [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).

Eligibility Criteria

Criteria

Ages Eligible for Study:
17 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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

Contacts and Locations

Locations

Site City State Country Postal Code
1 St. Joseph's Healthcare Hamilton Hamilton Ontario Canada L8N3K7

Sponsors and Collaborators

  • University of Waterloo
  • St. Joseph's Healthcare Hamilton

Investigators

  • Principal Investigator: Allison Kelly, PhD, University of Waterloo

Study Documents (Full-Text)

None provided.

More Information

Publications

Responsible Party:
Allison Kelly, Associate Professor, University of Waterloo
ClinicalTrials.gov Identifier:
NCT04174703
Other Study ID Numbers:
  • 41135
First Posted:
Nov 22, 2019
Last Update Posted:
May 20, 2021
Last Verified:
May 1, 2021
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 20, 2021