Ignite Creation Date:
2025-12-24 @ 1:57 PM
Ignite Modification Date:
2025-12-31 @ 8:31 AM
Study NCT ID:
NCT06133595
Status:
RECRUITING
Last Update Posted:
2024-10-10
First Post:
2023-10-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Individuals with Sexual Interest in Children
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D010378', 'term': 'Pedophilia'}], 'ancestors': [{'id': 'D010262', 'term': 'Paraphilic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Participants are allocated to either the Mi Bridge intervention or waitlist during the initial phase of the study and those who receive waitlist receive Mi Bridge during the second phase of the study.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-09-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2024-10-08', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-08', 'studyFirstSubmitDate': '2023-10-12', 'studyFirstSubmitQcDate': '2023-11-13', 'lastUpdatePostDateStruct': {'date': '2024-10-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Motivation to seek treatment', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'The Motivation to Seek Care questionnaire, item 1, which targets motivation to seek treatment for problems related to sexual interest involving children (Likert scale 1-7; higher scores indicates higher motivation).'}, {'measure': 'Motivation to make a change', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Responses on the Change Questionnaire (3 items, ordinal from 0 - 10; 0 - 30 points in total; higher score indicates more readiness to make a change related to sexual behaviors involving children).'}], 'secondaryOutcomes': [{'measure': 'Plan to seek treatment coming month', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'The Motivation to Seek Care questionnaire, item 2, which targets the intention to actually seek treatment during the coming month for problems related to sexual interest involving children (Y/N, coded as 1=YES, and 2=NO).'}, {'measure': 'Sexual interest involving children', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Measured by Sexual Symptom Assessment Scale (SASS)(0-48 points; higher scores indicate more interest).'}, {'measure': 'Behaviors related to sexual interest in children', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Time spent last week (hours), as self reported on the SChiMRA+ part B, item 1-4.'}, {'measure': 'Level of hypersexuality', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Scores on the HBI-19 questionnaire (Hypersexual Behavior Inventory; 19-95 points; higher scores indicate higher level of sexuality; more than 52 points indicate hypersexuality).'}, {'measure': 'Dynamic risk for committing child sexual abuse', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Scores on Acute-2007 (21 items; 0-42 points; higher scores indicate higher dynamic risk for committing child sexual abuse).'}, {'measure': 'Depressive symtoms', 'timeFrame': 'Pre-intervention, during the intervention, and immediately after the intervention.', 'description': 'Scores on the PHQ-9 questionnaire (Patient Health Questionnaire; 0-27 points; higher scores indicate more severe depressive symptoms).'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Child sexual abuse material', 'Motivational Interviewing', 'Evidence based treatment', 'Individuals with sexual interest in children'], 'conditions': ['Child Sexual Abuse', 'Pedophilia']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.iterapi.se/sites/bridge', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'The overall aim of the study is to evaluate the effectiveness of Mi Bridge to motivate high risk participants to admit to treatment.\n\nThe main research question is:\n\nIs Mi Bridge, an anonymous online program based on the principles for Motivational Interviewing, effective in making high risk individuals for committing child sexual abuse prone to seek treatment for problems related to sexual interest involving children at a health care facility?', 'detailedDescription': 'The present research project aims to contribute to the further development of accessible, evidence-based and safe care for people with sexual interest in children, and that are using child sexual abuse material (CSAM), so that these people can access treatment according to their needs and level of risk, with the objective of reducing the risk for child sexual abuse and improving the health of the group.\n\nThe intervention will be available in seven languages and will be tested in six countries.\n\nPrimary research questions:\n\nDoes Mi Bridge increase the likelihood that individuals at high risk for committing child sexual abuse accept seeking treatment for problems related to sexual interest involving minors at a health care facility?\n\nDoes Mi Bridge increase participants motivation for change regarding sexual behaviors involving minors?\n\nSecondary research questions:\n\nDoes Mi Bridge increase the intention to seek treatment in the coming month for problems related to sexual interest involving minors at a health care facility?\n\nDoes Mi Bridge decrease participants sexual interest involving children?\n\nDoes Mi Bridge significantly decreases participants past week sexual behaviors involving children?\n\nDoes Mi Bridge significantly decreases participants symptoms of depression?\n\nIs Mi Bridge effective in reducing certain dynamic risk factors for committing child sexual abuse?\n\nAbout the intervention. Mi Bridge is a series of up to five conversations between a practitioner and a study participant over three weeks to help the participants understand more about themselves and their willingness to change, and to help the participants connect with the care they need and want. The conversations are carried out as anonymous voice calls or anonymous text-based chat. Mi Bridge is based on the established and well-researched method of Motivational Interviewing, which has been shown to be effective in helping people achieve the desired changes for several lifestyle related problems.\n\nResearch subjects will be recruited through Darknet and Clearnet. Darknet refers to websites that are accessible via Tor or similar services. The intervention is provided by practitioners and researchers in the relevant countries.\n\nMi Bridge will be evaluated through an international multicenter study using randomized wait-list controlled design.\n\nThe research subjects will sign a written consent form on the Iterapi platform without disclosing personal data such as name or location. During the subsequent screening interview via chat or voice call on Iterapi, participation criteria are ensured, questions are answered, and the consent to participate is confirmed. The research subjects are thus admitted to the study.\n\nAfter inclusion, participants answer the baseline survey which consists of validated self-assessment questionnaires with both multiple choice and free-text answers.\n\nWeekly during, after the waitlist, and after the therapeutic intervention, research subjects answer questions to evaluate the effectiveness and safety of the interventions.\n\nA Statistical Analysis Plan (SAP) based on pilot study is pre-registered at the OSF platform. The SAP describes sample size calculations, and planned analyses of outcome measures.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Sufficient language skills: English, Swedish, Finnish, Czech, Slovak, German, or Spanish\n\n * Concerns about sexual interest regarding children\n * CSAM use past six month\n * High risk for committing child sexual abuse according to the SChiMRA scale\n\nExclusion Criteria:\n\n* Participants with a severe psychiatric illness (such as high acute suicide risk or severe substance abuse) will be excluded, or lack of serious intentions to participate.'}, 'identificationModule': {'nctId': 'NCT06133595', 'acronym': 'Mi Bridge', 'briefTitle': 'Mi Bridge - Motivational Interviewing to Facilitate Help-seeking Among Individuals with Sexual Interest in Children', 'organization': {'class': 'OTHER', 'fullName': 'Karolinska Institutet'}, 'officialTitle': 'A Multicenter, Waitlist Controlled, Randomized Clinical Trial of the Effectiveness of Mi Bridge, a Motivational Interviewing Intervention to Facilitate Help-seeking Among Individuals with Sexual Interest in Children', 'orgStudyIdInfo': {'id': '2023-02321-01-B'}, 'secondaryIdInfos': [{'id': '101084355-BRIDGE-ISF-2021', 'type': 'OTHER', 'domain': 'European Commission'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Experimental: MiBridge', 'description': 'MiBridge: A series of five conversations over three weeks to help participants understand more about themselves and their willingness to change, and to help participants connect with the care they need and want.', 'interventionNames': ['Behavioral: Behavioral: MiBridge']}, {'type': 'NO_INTERVENTION', 'label': 'No Intervention: Waitlist', 'description': 'Participants are on a waitlist which means they have no active intervention, only weekly measurements with the same questionnaires as in the active arm'}], 'interventions': [{'name': 'Behavioral: MiBridge', 'type': 'BEHAVIORAL', 'description': 'A series of five conversations over three weeks to help participants understand more about themselves and their willingness to change, and to help participants connect with the care they need and want.', 'armGroupLabels': ['Experimental: MiBridge']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Klecany', 'status': 'RECRUITING', 'country': 'Czechia', 'contacts': [{'name': 'Katerina Klapilova, Ass Profes', 'role': 'CONTACT'}], 'facility': 'National Institute of Mental Health', 'geoPoint': {'lat': 50.17599, 'lon': 14.41148}}, {'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Nina Vaarhanen-Valkonen', 'role': 'CONTACT'}], 'facility': 'Protect Children NGO', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'city': 'Hamburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Peer Briken, Professor', 'role': 'CONTACT'}], 'facility': 'University Medical Center Hamburg-Eppendorf', 'geoPoint': {'lat': 53.55073, 'lon': 9.99302}}, {'city': 'Bratislava', 'status': 'RECRUITING', 'country': 'Slovakia', 'contacts': [{'name': 'Josef Metenko, Professor', 'role': 'CONTACT'}], 'facility': 'Bratislava Police Academy', 'geoPoint': {'lat': 48.14816, 'lon': 17.10674}}, {'city': 'Castellon', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rafael Ballester, Professor', 'role': 'CONTACT'}], 'facility': 'Universitat Jaume I', 'geoPoint': {'lat': 39.98567, 'lon': -0.04935}}, {'city': 'Stockholm', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Christoffer Rahm, MD PhD', 'role': 'CONTACT', 'email': 'christoffer.rahm@ki.se', 'phone': '+46793393723'}, {'name': 'Christoffer Rahm, MD PhD', 'role': 'CONTACT'}], 'facility': 'Centre for psychiatry research, Region Stockholm', 'geoPoint': {'lat': 59.32938, 'lon': 18.06871}}], 'centralContacts': [{'name': 'Christoffer Rahm, MD, PhD', 'role': 'CONTACT', 'email': 'christoffer.rahm@ki.se', 'phone': '+46793393723'}, {'name': 'Maria Breide', 'role': 'CONTACT', 'email': 'maria.breide@ki.se', 'phone': '+46735563825'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Karolinska Institutet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Centre for Psychiatry Research, Region Stockholm, Sweden', 'class': 'UNKNOWN'}, {'name': 'Linkoeping University', 'class': 'OTHER_GOV'}, {'name': 'Universitat Jaume I, Spain', 'class': 'UNKNOWN'}, {'name': 'Protect Children Organisation, Finland', 'class': 'UNKNOWN'}, {'name': 'National Institute of Mental Health, Czech Republic', 'class': 'OTHER'}, {'name': 'Academy of the Police Force, Bratislava, Slovakia', 'class': 'UNKNOWN'}, {'name': 'Universitätsklinikum Hamburg-Eppendorf', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Christoffer Rahm', 'investigatorAffiliation': 'Karolinska Institutet'}}}}