Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2026-02-21 @ 6:52 PM
Study NCT ID:
NCT06719167
Status:
ENROLLING_BY_INVITATION
Last Update Posted:
2024-12-05
First Post:
2024-11-20
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Pilot Research Project on Outcome of Trauma Informed Stabilization Treatment (TIST) for Adults with Complex Trauma Symptoms After Childhood Trauma, At the Department of Trauma Treatment, Modum Bad, Norway
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013313', 'term': 'Stress Disorders, Post-Traumatic'}], 'ancestors': [{'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 32}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'ENROLLING_BY_INVITATION', 'startDateStruct': {'date': '2024-10-24', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2026-12-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-12-02', 'studyFirstSubmitDate': '2024-11-20', 'studyFirstSubmitQcDate': '2024-12-02', 'lastUpdatePostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Difficulties in emotion regulation scale (DERS)', 'timeFrame': 'Week 0 (Admission), week 11-12 (discharge) and 8 months follow up', 'description': 'Difficulties in emotion regulation scale, scale and subscales'}, {'measure': 'Five facet mindfulness questionnaire (FFMQ)', 'timeFrame': 'Week 0 (Admission), week 11-12 (discharge) and 8 months follow up', 'description': 'Five facet mindfulness questionnaire, all subscales'}, {'measure': 'Self-compassion scale long form (SCS-LF)', 'timeFrame': 'Week 0 (Admission), week 11-12 (discharge) and 8 months follow up', 'description': 'Self-compassion scale long form, scale and subscales'}, {'measure': 'PTSD checklist for DSM-5 (PCL-5)', 'timeFrame': 'Week 0 (Admission), week 11-12 (discharge) and 8 months follow up', 'description': 'PTSD checklist for DSM-5, scale and subscales'}, {'measure': 'International trauma questionnaire (ITQ)', 'timeFrame': 'Week 0 (Admission), week 11-12 (discharge) and 8 months follow up', 'description': 'International trauma questionnaire, scale and subscales'}], 'secondaryOutcomes': [{'measure': 'Patient health questionnaire 9 (PHQ-9)', 'timeFrame': 'Week 0 (Admission), week 11-12 (discharge) and 8 months follow up', 'description': 'Patient health questionnaire 9'}, {'measure': 'Quality of life', 'timeFrame': 'Week 0 (Admission), week 11-12 (discharge) and 8 months follow up', 'description': 'Self report on scale of 0-10'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['complex PTSD', 'childhood trauma', 'TIST', 'group treatment', 'affect regulation', 'mindfulness', 'self compassion'], 'conditions': ['PTSD and Trauma-related Symptoms', 'PTSD']}, 'descriptionModule': {'briefSummary': 'The purpose of the study is to examine the effects of residential group and individual Trauma Informed Stabilization Treatment (TIST) for complex symptoms in adult survivors of childhood trauma in a naturalistic observational study.', 'detailedDescription': 'Adult survivors of childhood trauma have complex and diverse symptom profiles. The aim of the study is to examine the effects of theTrauma Informed Stabilization Treatment (TIST) model, developed by dr Janina Fisher, in adult survivors of childhood trauma.\n\n32 patients will be recruited from referrals to an residential open door trauma clinic in Norway, Modum Bad. Patients will be admitted for in-patient pre-planned treatment over 11 weeks - consisting of individual therapy and group therapy using different modalities, all within the TIST approach and framework. Patients will be summoned for 6 day follow-up 8 months after treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients will be recruited from referrals to the clinic after assessment of eligibilty criteria.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults ≥18 years\n* Complex symptom presentations connected to childhood trauma\n* All patients will have undergone outpatient therapy with insufficient effect\n* Most included patients will have a diagnosis of complex PTSD (diagnosed by M.I.N.I. and clinical evaluation)\n* Patients may have diagnosis of unspecified dissociative disorder, personality disorders, depression and other comorbidity.\n\nExclusion criteria:\n\n* Dissociative identitiy disorder\n* Ongoing psychosis\n* Ongoing drug addiction\n* Very disturbed group function\n* Ongoing life crisis\n* Mental disability\n* Acute suicidality\n* Ongoing severe self harm\n* Patients with complex dissociative disorders and patients eligible for exposure therapy will be referred to/prioritized for other treatment programmes.'}, 'identificationModule': {'nctId': 'NCT06719167', 'briefTitle': 'A Pilot Research Project on Outcome of Trauma Informed Stabilization Treatment (TIST) for Adults with Complex Trauma Symptoms After Childhood Trauma, At the Department of Trauma Treatment, Modum Bad, Norway', 'organization': {'class': 'OTHER', 'fullName': 'Modum Bad'}, 'officialTitle': 'Residential Group and Individual Trauma Informed Stabilization Therapy for Adult Survivors of Childhood Trauma', 'orgStudyIdInfo': {'id': 'TIST pilot project'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Treatment', 'description': 'All group and individual therapy will be in line with the Trauma Informed Stabilization Treatment (TIST) model, developed by dr Janina Fisher. Patients will be admitted for in-patient pre-planned treatment over 11 weeks in an open door psychiatric hospital. Patients will be summoned for 6 day follow-up 8 months after discharge.', 'interventionNames': ['Behavioral: Psychoterapy']}], 'interventions': [{'name': 'Psychoterapy', 'type': 'BEHAVIORAL', 'otherNames': ['TIST', 'Trauma Informed Stabilization Treatment'], 'description': 'During 11 weeks admission the programme will include group sessions using different modalities (psychoeducation videos, live psychoeducation groups, expressive arts therapy, equine facilitated therapy, mindfulness and discussion groups) all using TIST methodology. Parallell individual therapy with therapist (psychologist or psychiatrist) and milieu therapist. All therapists will be trained minimum in TIST level 1 and recieve supervision from an expert TIST therapist.', 'armGroupLabels': ['Treatment']}]}, 'contactsLocationsModule': {'locations': [{'zip': '3535', 'city': 'Vikersund', 'state': 'Buskerud', 'country': 'Norway', 'facility': 'Modum Bad', 'geoPoint': {'lat': 59.96838, 'lon': 9.99107}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Modum Bad', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}