Ignite Creation Date:
2025-12-24 @ 11:29 PM
Ignite Modification Date:
2026-01-02 @ 2:58 AM
Study NCT ID:
NCT04737356
Status:
COMPLETED
Last Update Posted:
2022-09-19
First Post:
2021-01-28
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
SIA - Internet-administered CBT for Adolescents With Low Self-esteem
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 52}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-02-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-09', 'completionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-09-16', 'studyFirstSubmitDate': '2021-01-28', 'studyFirstSubmitQcDate': '2021-02-02', 'lastUpdatePostDateStruct': {'date': '2022-09-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-02-03', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-02-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Rosenberg Self-Esteem Scale', 'timeFrame': 'Before treatment, after 3 weeks, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'A 10-item measure of self-esteem. Sum scores range between 0-30. A higher score indicates a higher self-esteem.'}], 'secondaryOutcomes': [{'measure': 'Change in Brunnsviken Brief Quality of Life Questionnaire', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'Measure of subjective quality of life. Sum scores can range between 0 and 96. Higher scores indicate a higher quality of life.'}, {'measure': 'Change in Robson Self-concept Questionnaire', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'A 30-item measure of self-esteem. Sum scores range between 0-210. A higher score indicates a higher self-esteem.'}, {'measure': 'Change in Self-Compassion Scale Short Format', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'A 12-item measure of self-compassion. Sum scores range between 1-5. A higher score indicates higher self-compassion.'}, {'measure': 'Change in Performance based self-esteem Scale', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'A 4-item measure of performance based self-esteem. Sum scores range between 4-20. A higher score indicates a higher performance based self-esteem.'}, {'measure': 'Change in Patient Health Questionnaire', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'A 9 item measure of depressive symptoms. Sum scores range from 0-27. A higher score indicates more depressive symptoms.'}, {'measure': 'Change in Generalised Anxiety Disorder 7-item scale', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'Seven item measure of generalized anxiety disorder. Sum score range from 0 to 21, with higher scores indicating more generalized anxiety. Cut-offs for interpretation: 0-5 minimal anxiety, 6-9 mild anxiety, 10-14 moderate anxiety, and 15-21 severe anxiety.'}, {'measure': 'Change in Alcohol Use Disorder Identification Test', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'A 10 item measure of alcohol use disorders. Sum scores range from 0-40. A higher score indicates higher alcohol use.'}, {'measure': 'Change in Rathus assertiveness schedule - 6', 'timeFrame': 'Before treatment, after 7 weeks and follow-up at 12 months after treatment termination.', 'description': 'Six item measure of assertiveness. Sum score range from -18 to 18. A higher score indicates higher assertiveness.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive behavior therapy'], 'conditions': ['Self Esteem']}, 'descriptionModule': {'briefSummary': 'The study will investigate a novel CBT based treatment approach for low self-esteem among adolescents.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT'], 'maximumAge': '19 Years', 'minimumAge': '15 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Low self-esteem, as indicated by rating of \\< 20 the Rosenberg Self-Esteem Scale.\n* Age between 15 and 19 years old.\n* Access to a computer, smartphone, or tablet with internet access.\n* Write and speak Swedish.\n* In case of use of psychotropical medication, a stable dose for the past three months prior to registration and no planned changes during the treatment.\n\nExclusion Criteria:\n\n* Other ongoing psychological treatment that affects the treatment received in the study.\n* No comorbid severe depressive symptoms and no suicidal plans.\n* Ongoing alcohol use disorder, as indicated by Alcohol Use Disorders Identification Test (AUDIT).\n* Severe psychiatric comorbidities (e.g. psychosis, anorexia nervosa) that requires specialist care within the regular psychiatric care.'}, 'identificationModule': {'nctId': 'NCT04737356', 'briefTitle': 'SIA - Internet-administered CBT for Adolescents With Low Self-esteem', 'organization': {'class': 'OTHER_GOV', 'fullName': 'Linkoeping University'}, 'officialTitle': 'SIA - Internet-administered CBT for Adolescents With Low Self-esteem', 'orgStudyIdInfo': {'id': 'SIA'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Cognitive Behavior Therapy', 'description': 'Therapist-Guided Internet based Cognitive Behavior Therapy', 'interventionNames': ['Behavioral: Cognitive behavior therapy']}, {'type': 'NO_INTERVENTION', 'label': 'Wait-list control', 'description': 'Wait-list control participants will receive the same treatment at the end of the study period.'}], 'interventions': [{'name': 'Cognitive behavior therapy', 'type': 'BEHAVIORAL', 'description': 'Internet-based CBT intervention based on CBT theory as well as self-determination therapy for low self-esteem among adolescents.', 'armGroupLabels': ['Cognitive Behavior Therapy']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Linköping', 'country': 'Sweden', 'facility': 'Linköping University', 'geoPoint': {'lat': 58.41086, 'lon': 15.62157}}], 'overallOfficials': [{'name': 'Gerhard Andersson', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Linkoeping University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Gerhard Andersson', 'investigatorAffiliation': 'Linkoeping University'}}}}