NCT04174703

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
160

participants targeted

Target at P75+ for not_applicable

Timeline
5mo left

Started Sep 2020

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress93%
Sep 2020Dec 2026

First Submitted

Initial submission to the registry

November 4, 2019

Completed
18 days until next milestone

First Posted

Study publicly available on registry

November 22, 2019

Completed
10 months until next milestone

Study Start

First participant enrolled

September 29, 2020

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

January 28, 2026

Status Verified

January 1, 2026

Enrollment Period

6.2 years

First QC Date

November 4, 2019

Last Update Submit

January 26, 2026

Conditions

Outcome Measures

Primary Outcomes (3)

  • 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

  • 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

  • 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 Outcomes (2)

  • Eating Disorder Examination Questionnaire (EDE-Q)

    Change from day 1 to week 25 of group eating disorder treatment

  • Clinical Impairment Assessment (CIA)

    Change from day 1 to week 25 of group eating disorder treatment

Study Arms (2)

Self-compassionate letter-writing intervention

EXPERIMENTAL

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

Other: Self-compassionate letter-writing intervention

Control condition

NO INTERVENTION

Interventions

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.

Self-compassionate letter-writing intervention

Eligibility Criteria

Age17 Years+
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • 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
  • years of age or older

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N3K7, Canada

Location

Related Publications (3)

  • 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.

    PMID: 30102787BACKGROUND
  • 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.

    PMID: 27237928BACKGROUND
  • 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.

    PMID: 22917037BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersAnorexia NervosaBulimia NervosaBinge-Eating Disorder

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental Disorders

Study Officials

  • Allison Kelly, PhD

    University of Waterloo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
CARE PROVIDER
Masking Details
The care providers will not be told which condition each participant was assigned to.
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: 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.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

November 4, 2019

First Posted

November 22, 2019

Study Start

September 29, 2020

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

January 28, 2026

Record last verified: 2026-01

Data Sharing

IPD Sharing
Will not share

Locations