Ignite Creation Date:
2025-12-25 @ 4:59 AM
Ignite Modification Date:
2026-03-02 @ 8:40 PM
Study NCT ID:
NCT06610318
Status:
COMPLETED
Last Update Posted:
2024-09-24
First Post:
2024-09-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility and Acceptability of a Single Session of Imagery Rescripting in a Community Sample of Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D000098322', 'term': 'Disordered Eating Behavior'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D015596', 'term': 'Nutrition Assessment'}], 'ancestors': [{'id': 'D003625', 'term': 'Data Collection'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D017531', 'term': 'Health Care Evaluation Mechanisms'}, {'id': 'D011787', 'term': 'Quality of Health Care'}, {'id': 'D017530', 'term': 'Health Care Quality, Access, and Evaluation'}, {'id': 'D015991', 'term': 'Epidemiologic Measurements'}, {'id': 'D011634', 'term': 'Public Health'}, {'id': 'D004778', 'term': 'Environment and Public Health'}]}}, 'protocolSection': {'designModule': {'phases': ['EARLY_PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 27}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-09', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-09-19', 'studyFirstSubmitDate': '2024-09-17', 'studyFirstSubmitQcDate': '2024-09-19', 'lastUpdatePostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-09-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-04-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'enrollment', 'timeFrame': 'once, at baseline, over the duration of recruitment to obtain the sample size of interest', 'description': 'the total number of participants enrolled in the study and a demographic description of these participants, including their sex, gender, race, ethnicity, age and body mass index'}, {'measure': 'fidelity', 'timeFrame': 'during the intervention session only', 'description': 'the % of intervention curriculum the interventionists cover during their intervention session as rated by research staff using a curriculum checklist'}, {'measure': 'data collection completeness', 'timeFrame': 'baseline, intervention, 1-month, and 3-month', 'description': '% of missing data collected at all study visits'}, {'measure': 'intervention acceptability', 'timeFrame': 'these data will be collected during the 1-month follow-up visit', 'description': 'captured via self-report survey items created by the researchers; participants were asked questions such as the extent to which they liked engaging in the intervention; response options are on a Likert-type scale ranging from strongly agree to strongly disagree; average scores at the item level will be generated by condition'}, {'measure': 'safety', 'timeFrame': 'these data will be collected during and between all study visits, from baseline though the 3-month follow-up visit', 'description': 'frequency of adverse events'}, {'measure': 'retention', 'timeFrame': 'from baseline through the 3-month follow-up visit', 'description': 'the % of participants retained at each visit relative to baseline (i.e., percentage of total enrolled who attended the intervention visit, the 1-month follow-up visit, and the 3-month follow-up visit)'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feasibility Studies', 'Acceptability', 'Depressive Symptoms', 'Disordered Eating Behaviors']}, 'referencesModule': {'references': [{'pmid': '40270079', 'type': 'DERIVED', 'citation': 'Kelly NR, Doty KJ, Schrag BHC, Bryant S, Plezia S, Parr NJ, Budd EL. Feasibility and acceptability of a pilot randomized trial of a single session of imagery rescripting targeting the primary consequences of negative experiences with eating and appearance. Pilot Feasibility Stud. 2025 Apr 23;11(1):51. doi: 10.1186/s40814-025-01630-8.'}]}, 'descriptionModule': {'briefSummary': 'Negative experiences related to eating and appearance (NEREAs), such as critical commentary from parents about food, are common. They are also associated with depression and disordered eating, predictors of early mortality. Imagery rescripting (IR) is a therapeutic process during which individuals are guided through recalling distressing memories, like NEREAs, and generating ideas for bringing support into these memories. Single sessions of IR demonstrate promise in shifting the primary negative consequences of NEREAs in clinical samples of women. The current study examined the feasibility and acceptability of a remote-delivered, single session of IR in a community sample of men and women with NEREAs.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. ≥18 years old\n2. endorse a history of at least one negative experience related to eating and/or appearance\n\nExclusion Criteria:\n\n1. endorsed a current major medical condition;\n2. met criteria for a full threshold psychiatric disorder (of moderate intensity when severity ratings are necessary, such as for substance use disorders and binge eating disorder);\n3. were at high risk for suicide;\n4. endorsed current or recent pregnancy or anticipated becoming pregnant within the next year;\n5. were taking medication known to affect eating, weight and/or chronic disease risk;\n6. were participating in eating, weight, or diabetes programming;\n7. experienced weight loss \\> 10% in the past six months; and/or\n8. could not complete study procedures in English.'}, 'identificationModule': {'nctId': 'NCT06610318', 'briefTitle': 'Feasibility and Acceptability of a Single Session of Imagery Rescripting in a Community Sample of Adults', 'organization': {'class': 'OTHER', 'fullName': 'University of Oregon'}, 'officialTitle': 'Brief Strategies for Improving Health Outcomes', 'orgStudyIdInfo': {'id': 'STUDY00000529'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Imagery rescripting', 'description': "This condition has three stages. In the first stage, participants were asked to select their most distressing memory related to their appearance (not physical or sexual trauma). They were asked to visualize the selected memory, in detail, as if it were happening to them again. Then, interventionists used a downward arrow technique to identify two-to-three maladaptive core schema. In the second stage, participants were asked to identify a real or imagined trusted adult. Then, they were asked to imagine what their younger self might need to cope with or feel calmer in the situation of their selected memory. In the third stage, the participant was instructed to imagine asking the trusted adult for what they need and to imagine the trusted adult providing their selected interventions and describe how they feel afterwards. These procedures were then repeated with participants' most distressing memory related to eating. This session was remote delivered via Zoom.", 'interventionNames': ['Behavioral: imagery rescripting']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Nutrition education control', 'description': "The active control condition consisted of a time- and attention-matched general nutrition education session. The curriculum for this intervention included information from the United States Department of Agriculture's Dietary Guidelines (e.g., food labels, describing the benefits of macronutrients). This session was remote delivered using Zoom.", 'interventionNames': ['Behavioral: nutrition education']}], 'interventions': [{'name': 'imagery rescripting', 'type': 'BEHAVIORAL', 'description': "This condition has three stages. In the first stage, participants were asked to select their most distressing memory related to their appearance (not physical or sexual trauma). They were asked to visualize the selected memory, in detail, as if it were happening to them again. Then, interventionists used a downward arrow technique to identify two-to-three maladaptive core schema. In the second stage, participants were asked to identify a real or imagined trusted adult. Then, they were asked to imagine what their younger self might need to cope with or feel calmer in the situation of their selected memory. In the third stage, the participant was instructed to imagine asking the trusted adult for what they need and to imagine the trusted adult providing their selected interventions and describe how they feel afterwards. These procedures were then repeated with participants' most distressing memory related to eating. This session was remote delivered via Zoom.", 'armGroupLabels': ['Imagery rescripting']}, {'name': 'nutrition education', 'type': 'BEHAVIORAL', 'description': "The active control condition consisted of a time- and attention-matched general nutrition education session. The curriculum for this intervention included information from the United States Department of Agriculture's Dietary Guidelines (e.g., food labels, describing the benefits of macronutrients). This session was remote delivered using Zoom.", 'armGroupLabels': ['Nutrition education control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '97401', 'city': 'Eugene', 'state': 'Oregon', 'country': 'United States', 'facility': 'University of Oregon', 'geoPoint': {'lat': 44.05207, 'lon': -123.08675}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Oregon', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}