Ignite Creation Date:
2025-12-24 @ 3:04 PM
Ignite Modification Date:
2025-12-26 @ 2:47 PM
Study NCT ID:
NCT05784259
Status:
RECRUITING
Last Update Posted:
2023-12-15
First Post:
2023-03-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Development of Transdiagnostic Single-session Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}, {'id': 'D040921', 'term': 'Stress Disorders, Traumatic'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D000068099', 'term': 'Trauma and Stressor Related Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Randomized controlled trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 300}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2023-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2025-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-12-11', 'studyFirstSubmitDate': '2023-03-13', 'studyFirstSubmitQcDate': '2023-03-13', 'lastUpdatePostDateStruct': {'date': '2023-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-03-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Anxiety, Depression and Stress symptoms post-treatment', 'timeFrame': '3 weeks post-treatment', 'description': 'Measured using DASS-21'}, {'measure': 'Anxiety, Depression and Stress symptoms follow-up', 'timeFrame': '6 months post-treatment', 'description': 'Measured using DASS-21'}, {'measure': 'Anxiety sensitivity post-treatment', 'timeFrame': '3 weeks post-treatment', 'description': 'Measured using BSQ, fear of bodily sensations related to anxiety'}, {'measure': 'Anxiety sensitivity follow-up', 'timeFrame': '6 months post-treatment', 'description': 'Measured using BSQ, fear of bodily sensations related to anxiety'}, {'measure': 'Experiential avoidance post-treatment', 'timeFrame': '3 weeks post-treatment', 'description': 'Measured using AFQ-Y8, psychological flexibility'}, {'measure': 'Experiential avoidance follow-up', 'timeFrame': '6 months post-treatment', 'description': 'Measured using AFQ-Y8, psychological flexibility'}, {'measure': 'Mindfulness post-treatment', 'timeFrame': '3 weeks post-treatment', 'description': 'Measured using FFMQ, mindfulness'}, {'measure': 'Mindfulness follow-up', 'timeFrame': '6 months post-treatment', 'description': 'Measured using FFMQ, mindfulness'}, {'measure': 'Alexithymia post-treatment', 'timeFrame': '3 weeks post-treatment', 'description': 'Measured using TAS-20, mindfulness'}, {'measure': 'Alexithymia follow-up', 'timeFrame': '6 months post-treatment', 'description': 'Measured using TAS-20, mindfulness'}, {'measure': 'Generalization', 'timeFrame': '6 months post-treatment', 'description': 'Qualitative interview with a few selected patients to review their experience of the treatment, its effectiveness and their ability to use the techniques taught.'}], 'secondaryOutcomes': [{'measure': 'Additional treatment', 'timeFrame': '6 months post-treatment', 'description': 'It will be recorded if patients sought additional care after single-session treatment as well as type of care.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['transdiagnostic', 'single-session'], 'conditions': ['Anxiety Disorders', 'Depression', 'Stress Disorder']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to test a single session treatment program in primary care patients with anxiety and/or depression and/or stress-related issues. The main questions it aims to answer is:\n\n* Will the transdiagnostic treatment program decrease symptoms of depression/anxiety/stress?\n* Will the transdiagnostic treatment program decrease transdiagnostic risk factors?\n* Will the transdiagnostic treatment program decrease the measured risk factors equally?\n* Will the transdiagnostic treatment program impact patients with anxiety, depression or stress disorders equally?\n* Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on transdiagnostic risk factors?\n* Will the transdiagnostic treatment program have long term (6 months post-treatment) effect on anxiety, depression, or stress-symptoms?\n* Have the participants been able to generalize the skills taught in the program(qualitative)?\n* Within group that were treated with single-session treatment and recieved additional care before follow-up, was there a difference in outcome?', 'detailedDescription': 'The study investigates the effect of a single-session, 4 hour, transdiagnostic treatment for primary care patientst with depression, anxiety or stress.\n\nThe treatment includes, interoceptive exposure, behavioral activation, mindfulness, defusion and psycho-education about emotions.\n\nThe study is conducted in a clinical setting in northern sweden and follows up results at 3 weeks and 6 months post treatment.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Meet the criteria for anxiety, mood disorder, or stress diagnosis\n* Symptoms are mild to moderate in severity\n\nExclusion Criteria:\n\n* Already in ongoing psychotherapy\n* Within a month commenced pharmaceutical treatment that will likely impact mood or psychological functioning and is not deemed to be on a stable dose\n* Has a comorbid personality disorder\n* Has a risk of suicide deemed other than low\n* Has other severe psychological disorders outside the scope of primary care\n* Is in a severely stressful social situation deemed incompatible with psychotherapy'}, 'identificationModule': {'nctId': 'NCT05784259', 'briefTitle': 'Development of Transdiagnostic Single-session Treatment', 'organization': {'class': 'OTHER', 'fullName': 'Luleå Tekniska Universitet'}, 'officialTitle': 'Development and Clinical Trial of a Transdiagnostic Single-session Treatment for Primary Care Patients', 'orgStudyIdInfo': {'id': '275863'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control group'}, {'type': 'EXPERIMENTAL', 'label': 'Treatment group', 'description': 'Transdiagnostic single-session treatment', 'interventionNames': ['Behavioral: Transdiagnostic single-session treatment']}], 'interventions': [{'name': 'Transdiagnostic single-session treatment', 'type': 'BEHAVIORAL', 'description': 'Administered over 4 hour in group of 10 patients. Interventions are: Psychoeducation of emotions, De-fusion exercise, Mindfulness exercise, Interoceptive exposure, Behavioral activation', 'armGroupLabels': ['Treatment group']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Luleå', 'state': 'Norrbotten County', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'John Näsling', 'role': 'CONTACT', 'email': 'john.nasling@ltu.se', 'phone': '0730807767'}], 'facility': 'Region Norrbotten, Primary care', 'geoPoint': {'lat': 65.58415, 'lon': 22.15465}}], 'centralContacts': [{'name': 'John Näsling, Master', 'role': 'CONTACT', 'email': 'john.nasling@ltu.se', 'phone': '+4673 080 77 67'}], 'overallOfficials': [{'name': 'John Näsling, Master', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Luleå tekniska universitet/Region Norrbotten'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Luleå Tekniska Universitet', 'class': 'OTHER'}, 'collaborators': [{'name': 'Region Norrbotten', 'class': 'UNKNOWN'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Lic. psychologist / Doctoral student', 'investigatorFullName': 'John Näsling', 'investigatorAffiliation': 'Luleå Tekniska Universitet'}}}}