Ignite Creation Date:
2025-12-24 @ 7:30 PM
Ignite Modification Date:
2026-02-25 @ 8:15 PM
Study NCT ID:
NCT04174703
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2025-03-28
First Post:
2019-11-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D000856', 'term': 'Anorexia Nervosa'}, {'id': 'D052018', 'term': 'Bulimia Nervosa'}, {'id': 'D056912', 'term': 'Binge-Eating Disorder'}], 'ancestors': [{'id': 'D012817', 'term': 'Signs and Symptoms, Digestive'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['CARE_PROVIDER'], 'maskingDescription': 'The care providers will not be told which condition each participant was assigned to.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': '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.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 160}}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2020-09-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-03-24', 'studyFirstSubmitDate': '2019-11-04', 'studyFirstSubmitQcDate': '2019-11-21', 'lastUpdatePostDateStruct': {'date': '2025-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight- and Body-Related Shame and Guilt Scale (WEB-SG)', 'timeFrame': 'Change from baseline to post-2 weeks of intervention/control condition', '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).'}, {'measure': 'Self-compassion Scale (short form; SCS-SF)', 'timeFrame': 'Change from baseline to post-2 weeks of intervention/control condition', '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).'}, {'measure': 'Readiness to Change Eating Behaviours', 'timeFrame': 'Change from baseline to post-2 weeks of intervention/control condition', '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).'}], 'secondaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire (EDE-Q)', 'timeFrame': 'Change from day 1 to week 25 of group eating disorder treatment', '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).'}, {'measure': 'Clinical Impairment Assessment (CIA)', 'timeFrame': 'Change from day 1 to week 25 of group eating disorder treatment', '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).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Eating Disorders', 'Anorexia Nervosa', 'Bulimia Nervosa', 'Binge-Eating Disorder', 'Compassion']}, 'referencesModule': {'references': [{'pmid': '30102787', 'type': 'BACKGROUND', '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.'}, {'pmid': '27237928', 'type': 'BACKGROUND', '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.'}, {'pmid': '22917037', 'type': 'BACKGROUND', '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.'}]}, 'descriptionModule': {'briefSummary': "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.", 'detailedDescription': "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).\n\nFollowing 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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '17 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. DSM-5 diagnosis of anorexia nervosa, bulimia nervosa, or binge eating disorder\n2. Eligible to start group eating disorders treatment at St. Joseph's Eating Disorder Program\n3. 17 years of age or older\n\nExclusion Criteria: None"}, 'identificationModule': {'nctId': 'NCT04174703', 'briefTitle': 'Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing', 'organization': {'class': 'OTHER', 'fullName': 'University of Waterloo'}, 'officialTitle': 'Preparing for Eating Disorders Treatment Through Compassionate Letter-Writing', 'orgStudyIdInfo': {'id': '41135'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Self-compassionate letter-writing intervention', 'description': 'An online self-compassionate letter-writing task once per day (10-20 minutes each) for 2 weeks', 'interventionNames': ['Other: Self-compassionate letter-writing intervention']}, {'type': 'NO_INTERVENTION', 'label': 'Control condition'}], 'interventions': [{'name': 'Self-compassionate letter-writing intervention', 'type': 'OTHER', '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.', 'armGroupLabels': ['Self-compassionate letter-writing intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'L8N3K7', 'city': 'Hamilton', 'state': 'Ontario', 'country': 'Canada', 'facility': "St. Joseph's Healthcare Hamilton", 'geoPoint': {'lat': 43.25011, 'lon': -79.84963}}], 'overallOfficials': [{'name': 'Allison Kelly, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Waterloo'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Waterloo', 'class': 'OTHER'}, 'collaborators': [{'name': "St. Joseph's Healthcare Hamilton", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Allison Kelly', 'investigatorAffiliation': 'University of Waterloo'}}}}