Ignite Creation Date:
2025-12-25 @ 12:44 AM
Ignite Modification Date:
2025-12-26 @ 1:29 PM
Study NCT ID:
NCT04665167
Status:
COMPLETED
Last Update Posted:
2021-04-08
First Post:
2020-11-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
An Intervention for Eating and Body Image Concerns Among Young Adult Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-01-13', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2021-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-04-07', 'studyFirstSubmitDate': '2020-11-23', 'studyFirstSubmitQcDate': '2020-12-09', 'lastUpdatePostDateStruct': {'date': '2021-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-02-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of participants recruited', 'timeFrame': 'will measure upon study termination (estimated at 2-3 months)', 'description': '30 participants'}], 'secondaryOutcomes': [{'measure': 'The rate of completion', 'timeFrame': 'will measure upon study termination (estimated at 2-3 months)', 'description': 'assessed by the percentage of participants who complete the study questionnaires'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['eating pathology', 'body image', 'exposure', 'self-compassion'], 'conditions': ['Eating Disorder Symptom', 'Body Image Disturbance']}, 'referencesModule': {'references': [{'pmid': '12445587', 'type': 'BACKGROUND', 'citation': 'Franko DL, Striegel-Moore RH. The role of body dissatisfaction as a risk factor for depression in adolescent girls: are the differences Black and White? J Psychosom Res. 2002 Nov;53(5):975-83. doi: 10.1016/s0022-3999(02)00490-7.'}], 'seeAlsoLinks': [{'url': 'http://www.nice.org.uk/guidance/ng69/resources/eating-disorders-recognition-and-treatment-pdf-1837582159813', 'label': 'NICE, 2017. Eating disorders: recognition and treatment'}]}, 'descriptionModule': {'briefSummary': 'The primary aim of the current study is to assess acceptability and feasibility of online body image exposure and self-compassion interventions before conducting a larger RCT.', 'detailedDescription': 'This study will determine the feasibility and effectiveness of delivering an online therapy for eating pathology and body image disturbance. It will address body image and eating pathology in a non-clinical group of young adult women, who are at risk of developing such problems . The feasibility study will determine whether there are any difficulties that would need to be addressed in recruitment, online delivery and assessment of those treatments.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Self-identified women', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body shape questionnaire score \\> 25\n* Age ≥18\n* Self-identified women\n* Be able to use a computer and having an Internet connection and webcam\n\nExclusion Criteria:\n\n* Insufficient knowledge of English\n* Learning disability, severe mental illness or alcohol/substance dependence, history of self-injuries, current eating disorder, current clinical depression\n* Psychiatric illness requiring secondary care intervention\n* Male\n* Under 18 years old\n* Body mass index below 18.5\n* Currently undergoing psychological therapies\n* No access to a tablet or computer with an internet connection'}, 'identificationModule': {'nctId': 'NCT04665167', 'briefTitle': 'An Intervention for Eating and Body Image Concerns Among Young Adult Women', 'organization': {'class': 'OTHER', 'fullName': 'University of Sheffield'}, 'officialTitle': 'Feasibility of Online Exposure Therapy and Self-compassion Interventions for Eating and Body Image Concerns Among Young Adult Women', 'orgStudyIdInfo': {'id': '168743'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Body image exposure', 'description': 'Guided non-judgmental exposure, 40 minutes total', 'interventionNames': ['Behavioral: Body image exposure']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self-compassion', 'description': '8 Short self-compassion meditations, 40 minutes total', 'interventionNames': ['Behavioral: Self-compassion']}], 'interventions': [{'name': 'Body image exposure', 'type': 'BEHAVIORAL', 'description': 'Exposure therapy is a key element of evidence-based cognitive behaviour therapy for eating disorders . Body image exposure intervention involves deliberate, planned, and systematic exposure to the body image. Participants will be asked to stand so that they can see their whole body - far enough back. Participants will be asked to look at their bodies on screen. Participants will be continually encouraged by the facilitator for looking at and talking about the body parts.', 'armGroupLabels': ['Body image exposure']}, {'name': 'Self-compassion', 'type': 'BEHAVIORAL', 'description': "The self-compassion intervention condition consists of Neff's self-compassion exercises. These exercises are part of the self-compassion intervention condition. Meditation text used in this study is obtained from the following link https://self-compassion.org/category/exercises/.", 'armGroupLabels': ['Self-compassion']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S1 2LT', 'city': 'Sheffield', 'country': 'United Kingdom', 'facility': 'University of Sheffield', 'geoPoint': {'lat': 53.38297, 'lon': -1.4659}}], 'overallOfficials': [{'name': 'Fidan Turk', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sheffield'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sheffield', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}