Ignite Creation Date:
2025-12-24 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
Study NCT ID:
NCT06885866
Status:
COMPLETED
Last Update Posted:
2025-03-20
First Post:
2025-02-21
Is Possible Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}], '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': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'A single-case experimental randomized AB-design. Baseline length (i.e., phase A) and start of the B-phase is randomized for each participant. Both phases consist of active treatment, with the purpose of investigating if the interventions added in phase B could enhance treatment results additionally beyond the interventions given during the baseline period.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 12}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-03-02', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-13', 'studyFirstSubmitDate': '2025-02-21', 'studyFirstSubmitQcDate': '2025-03-13', 'lastUpdatePostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-03-20', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-06-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficulties in Emotion Regulation Scale, 36 items', 'timeFrame': 'At pre-treatment assessment one week before treatment start; at post-treatment assessment at day 63 counted from treatment start; and at follow-up assessment at day 153 counted from treatment start.', 'description': 'Assessment of emotion regulation difficulties. 36 items scored 1-5, higher scores indicate more difficulties. Total score range from 36-180.'}, {'measure': 'Difficulties in Emotion Regulation Scale, 16 items', 'timeFrame': 'Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60', 'description': 'Assessment of emotion regulation difficulties, short version. 16 items scored 1-5. Higher scores indicates more difficulties. Total score range from 16-80.'}, {'measure': 'The Positive and Negative Affect Schedule, short form', 'timeFrame': 'Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60', 'description': 'Assessment of affect levels. In this study, only the subscale measuring negative affect is used. 5 items scored 1-5. Higher scores indicate higher levels of negative affect. Total score range from 5-25.'}], 'secondaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire 6.0', 'timeFrame': 'At pre-treatment assessment one week before treatment start; at post-treatment assessment at day 63 counted from treatment start; and at follow-up assessment at day 153 counted from treatment start.', 'description': 'Assessment of eating disorder symptoms. 28 items scored 0-6. Higher scores represent more eating disorder pathology. Scores are summerized and scaled, giving a total score ranging from 0-6.'}, {'measure': 'Eating Disorder Symptom List', 'timeFrame': 'Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60', 'description': 'Assessment of eating disorder symptoms. 8 items scored 0-3, with higher scores indicating more frequent eating disorder symptoms. Total score range from 0-24.'}, {'measure': 'Clinical Impairment Assessment', 'timeFrame': 'At pre-treatment assessment one week before treatment start; at post-treatment assessment at day 63 counted from treatment start; and at follow-up assessment at day 153 counted from treatment start.', 'description': 'Assessment of eating disorder related psychosocial impairment. 16 items scored 0-3. Higher scores indicate higher impairment. Total score range from 0-48.'}, {'measure': 'Clinical Impairment Assessment, subscale social', 'timeFrame': 'Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60', 'description': 'Assessment of eating disorder related psychosocial impairment, subscale focusing on social impariment.\n\n5 items scored 0-3. Higher scores indicate higher impairment. Total score range from 0-15.'}, {'measure': 'Normalized eating pattern', 'timeFrame': 'Counted from treatment start: at day 1, 4, 9, 12, 15, 18, 21, 24, 27, 30, 33, 36, 39, 42, 45, 48, 51, 54, 57, 60', 'description': 'Self-assessment of eating patterns, developed by the authors for use in the present study. The self-assessment includes 2 questions:\n\n1. How many of the previous three days have you eaten regular meals approximately 6 times per day?\n2. How many of the previous three days have you eaten normal sized portions at all or almost all meals?\n\nItems are scored 0-3. Higher scores indicare more normalized meal habits. Lower scores indicate disordered eating. Total score range from 0-6.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Eating disorder treatment', 'Emotion regulation treatment', 'Internet treatment'], 'conditions': ['Eating Disorders']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to develop and test a new internet delivered treatment for adult patients with eating disorders, focused on developing normalized eating patterns and emotion regulation skills. The main focus is to investigate the additional effect of emotion regulation interventions, beyond the effect of other central tratment components normally included in evidence based eating disorder treatment.\n\nThe internet delivered treatment is divided into two phases, phase A and phase B. Phase A focus on establishing normalised eating patterns, and in phase B the emotion regulation interventions are added. Participants will get access to treatment modules every third day over a time period of 8.5 weeks, each module consist of psychopedagogical material, excercises and home work.\n\nData will be collected via the online research platform every third day during the treatment. Data is also collected at more comprehensive assessment points pre-treatment, post-treatment, and follow up 3 months after end of treatment.', 'detailedDescription': 'This study uses an experimental single-case design, specifically a randomized replicated AB design.\n\nThe baseline lenght (i.e., phase A) is randomized for each participant. There is six possible assignments, as the randomization is restricted to give all participants minimum 8 and maximum 12 treatment modules in each phase, with minimum 9 and maximum 14 baseline assessment points.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* DSM5 eating disorder\n* Minimum 18 years old\n* Ongoing contact with a psychiatric clinic in sweden\n\nExclusion Criteria:\n\n* Body mass index below 18,5\n* Somatic instability due to eating disorder severeness\n* High risk of suicide or severe self-harm\n* Ongoing addiction or substance abuse\n* Ongoing psychological treatment or psychotherapy\n* New or changed mediciation for psychiatric disorders in the past 2 months\n* Planned or ongoing pregnancy or recently gave birth'}, 'identificationModule': {'nctId': 'NCT06885866', 'briefTitle': 'Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'Emotion Focused Internet Delivered Treatment for Adults with Eating Disorders', 'orgStudyIdInfo': {'id': 'IBL-2021-00215'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Emotion regulation treatment', 'interventionNames': ['Behavioral: Emotion regulation treatment']}], 'interventions': [{'name': 'Emotion regulation treatment', 'type': 'BEHAVIORAL', 'description': 'Emotion regulation intervention in two phases. Phase A focus on establishing normalised eating patterns, and in phase B the emotion regulation interventions are added. Participants will get access to treatment modules every third day over a time period of 8.5 weeks, each module consist of psychopedagogical material, excercises and home work.', 'armGroupLabels': ['Emotion regulation treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58183', 'city': 'Linköping', 'state': 'Östergötland County', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Hugo Hesser, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Örebro University, Linköping University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'The data set analyzed during the present study is not publicly available, as it contains information that could compromise research participant privacy/consent. However, it could be made available on request to the corresponding author if granted by Swedish Ethical Review Authority.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Hugo Hesser', 'investigatorAffiliation': 'Linkoeping University'}}}}