Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2025-12-26 @ 3:02 AM
Study NCT ID:
NCT04213820
Status:
UNKNOWN
Last Update Posted:
2023-08-29
First Post:
2019-12-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
TMS and Body Image Treatment for Anorexia Nervosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000856', 'term': 'Anorexia Nervosa'}], 'ancestors': [{'id': 'D001068', 'term': 'Feeding and Eating Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D050781', 'term': 'Transcranial Magnetic Stimulation'}, {'id': 'D013812', 'term': 'Therapeutics'}], 'ancestors': [{'id': 'D055909', 'term': 'Magnetic Field Therapy'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2019-09-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-08', 'completionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-08-25', 'studyFirstSubmitDate': '2019-12-27', 'studyFirstSubmitQcDate': '2019-12-27', 'lastUpdatePostDateStruct': {'date': '2023-08-29', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-12-30', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-02', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Extrastriatal body area (EBA) activation during fMRI', 'timeFrame': 'Change from baseline at 4 weeks and at 6 months'}, {'measure': 'Extrastriatal body area (EBA) connectivity during resting state fMRI', 'timeFrame': 'Change from baseline at 4 weeks and at 6 months'}], 'primaryOutcomes': [{'measure': 'Eating Disorder Examination Questionnaire (EDE-Q)', 'timeFrame': 'Change from baseline at 4 weeks and at 6 months', 'description': 'EDE-Q measures symptoms of eating disorder. It contains at total of 36 items. 23 of these are rated on a Likert scale between 0-6 and contains 4 subscales: Restraint (ranging from 0-30); Eating concern (ranging from 0-30); shape concern (ranging from 0-48); weight concern (ranging from 0-30). Higher scores indicating more difficulties with eating disorder. In addition, 11 open ended questions concern binge eating and compensating behaviors.'}, {'measure': 'Body Attitude Test (BAT)', 'timeFrame': 'Change from baseline at 4 weeks and at 6 months', 'description': 'BAT measures attitudes toward one own body. It contains a total of 20 items that are rated on a Likert scale between 0-5. Total scores range from 0-100. Higher scores indicate more problems with body attitude.'}, {'measure': 'Body Shape Questionnaire (BSQ)', 'timeFrame': 'Change from baseline at 4 weeks and at 6 months', 'description': "BSQ measures dissatisfaction with one's own body/figure. It contains a total of 34 items, which are rated on a Likert scale ranging from 1-6. total scores range from 34-204, with higher scores indicating more dissatisfaction."}, {'measure': 'Figure Rating Scale', 'timeFrame': 'Change from baseline at 4 weeks and at 6 months', 'description': "Figure Rating Scale measures body image and estimation of one's own body size. Each figure presents nine schematic silhouettes, ranging from extreme thinness (1) to extreme obesity (9). For research purposes, participants are asked to self-select the silhouette that best indicates his or her current body size (ranging from 1-9) and the silhouette that reflects his or her ideal body size (ranging from 1-9)."}, {'measure': 'Body Mass Index (BMI)', 'timeFrame': 'Change from baseline at 4 weeks and at 6 months', 'description': "Body Mass Index is a person's weight in kilograms divided by the square of height in meters and is an indication of under- or overweight in adults."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anorexia Nervosa']}, 'descriptionModule': {'briefSummary': 'To evaluate if TMS together with a body image intervention is an efficacious treatment for anorexia nervosa compared to treatment as usual.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Being enrolled as a patient at the eating disorder unit of the Child and adolescent psychiatric clinic and Psychiatric clinic in Linköping\n* Having a DSM-5 diagnosis of anorexia nervosa, atypical anorexia (restrictive type)\n* Being at least 18 years of age\n* Having a BMI of 20 or under.\n* Being free of psychotropic medications or on stable (at least three months on the same dose) medication.\n\nExclusion Criteria:\n\n* Clinical diagnosis of schizophrenia or psychotic disorder\n* Clinical diagnosis of bipolar disorder\n* Alcohol/drug dependence\n* Ongoing treatment with antipsychotics or tricyclic antidepressants\n* Previous severe head injury\n* Birth before 33 weeks of gestation\n* Hearing impairment\n* Earlier epilepsy or seizures of other causes\n* Having severe claustrophobia\n* Being pregnant\n* Having a cognitive disability'}, 'identificationModule': {'nctId': 'NCT04213820', 'briefTitle': 'TMS and Body Image Treatment for Anorexia Nervosa', 'organization': {'class': 'OTHER', 'fullName': 'Region Östergötland'}, 'officialTitle': 'TMS Treatment for Anorexia Nervosa: Effects on Body Image Processing and Clinical Outcome Measures', 'orgStudyIdInfo': {'id': '2019-02821'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Treatment as usual', 'description': 'Participants will receive treatment as usual at the eating disorder unit at the Child and adolescent psychiatric clinic and at the Psychiatric clinic during 4 weeks.', 'interventionNames': ['Behavioral: Treatment as usual']}, {'type': 'EXPERIMENTAL', 'label': 'TMS and body image intervention', 'description': 'Participants will receive TMS and a body image intervention daily 5 times/week during 4 weeks', 'interventionNames': ['Device: Transcranial magnetic stimulation', 'Behavioral: Body Image Intervention']}, {'type': 'SHAM_COMPARATOR', 'label': 'sham TMS and body image intervention', 'description': 'Participants will receive sham TMS and a body image intervention Daily 5 times/week during 4 weeks', 'interventionNames': ['Behavioral: Body Image Intervention']}], 'interventions': [{'name': 'Transcranial magnetic stimulation', 'type': 'DEVICE', 'description': 'TMS (theta burst) will be administered consisting of bursts containing 3 pulses at 50 Hz and an intensity of 80% motor threshold repeated at 200 ms intervals (i.e., at 5 Hz) and a 10 s between burst triplet interval for a total for 190 s (600 pulses). The intervention will be given daily 5 times/week during 4 weeks.', 'armGroupLabels': ['TMS and body image intervention']}, {'name': 'Body Image Intervention', 'type': 'BEHAVIORAL', 'description': 'Body image interventions delivered directly after TMS will include body exercises that target disturbed body image and psychoeducation about the body. Together with a therapist the participants with anorexia nervosa will explore and estimate their body size through feedback.', 'armGroupLabels': ['TMS and body image intervention', 'sham TMS and body image intervention']}, {'name': 'Treatment as usual', 'type': 'BEHAVIORAL', 'description': 'Treatment as usual at the eating disorder unit, Child and adolescent psychiatric clinic and Psychiatric clinic is delivered during 4 weeks', 'armGroupLabels': ['Treatment as usual']}]}, 'contactsLocationsModule': {'locations': [{'zip': '581 85', 'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Maria A Zetterqvist, PhD', 'role': 'CONTACT', 'email': 'maria.zetterqvist@liu.se', 'phone': '+46 101034339'}, {'name': 'Rebecca Böhme, PhD', 'role': 'CONTACT', 'email': 'rebecca.bohme@liu.se'}], 'facility': 'Region Östergötland BUP-kliniken', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'centralContacts': [{'name': 'Maria A Zetterqvist, PhD', 'role': 'CONTACT', 'email': 'maria.zetterqvist@liu.se', 'phone': '+46 101034339'}, {'name': 'Rebecca Böhme, PhD', 'role': 'CONTACT', 'email': 'rebecca.bohme@liu.se'}], 'overallOfficials': [{'name': 'Maria A Zetterqvist, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Region Östergötland/Linköping university'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Region Östergötland', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Maria Zetterqvist', 'investigatorAffiliation': 'Region Östergötland'}}}}