Ignite Creation Date:
2025-12-24 @ 11:58 PM
Ignite Modification Date:
2025-12-25 @ 9:55 PM
Study NCT ID:
NCT07039058
Status:
WITHDRAWN
Last Update Posted:
2025-09-08
First Post:
2025-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Brief DBT Skills Training for Coping With Suicidal Ideation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 0}}, 'statusModule': {'whyStopped': 'Study was not initiated due to lack of resources.', 'overallStatus': 'WITHDRAWN', 'startDateStruct': {'date': '2025-10', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-09-02', 'studyFirstSubmitDate': '2025-06-18', 'studyFirstSubmitQcDate': '2025-06-18', 'lastUpdatePostDateStruct': {'date': '2025-09-08', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in the Suicidality at 1 Month as Assessed by Suicide Probability Scale', 'timeFrame': 'From enrollment to the end of intervention at 1 week and follow-up at 1 month', 'description': '36 is equivalent to the lowest suicidality, and 144 indicates the highest suicidality.'}, {'measure': 'Change from Baseline in the Suicidal Cognitions at 1 Month as Assessed by Suicide Cognitions Scale', 'timeFrame': 'From enrollment to the end of intervention at 1 week and follow-up at 1 month', 'description': '18 is equivalent to the lowest suicidal cognitions, and 90 indicates the highest suicidal cognitions.'}, {'measure': 'Change from Baseline in the Hopelessness at 1 Month as Assessed by Beck Hopelessness Scale', 'timeFrame': 'From enrollment to the end of intervention at 1 week and follow-up at 1 month', 'description': 'Zero is equivalent to the lowest hopelessness, and 20 indicates the highest hopelessness.'}, {'measure': 'Change from Baseline in the Emotion Regulation Skills at 1 Month as Assessed by Emotion Regulation Skills Questionnaire', 'timeFrame': 'From enrollment to the end of intervention at 1 week and follow-up at 1 month', 'description': 'Zero is equivalent to the lowest emotion regulation skills, and 108 indicates the highest skills.'}, {'measure': 'Change from Baseline in the Difficulties in Emotion Regulation at 1 Month as Assessed by Difficulties in Emotion Regulation Scale-16', 'timeFrame': 'From enrollment to the end of intervention at 1 week and follow-up at 1 month', 'description': '16 is equivalent to the lowest difficulties, and 80 indicates the highest difficulties in emotion regulation.'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in the Depression, Anxiety, and Stress at 1 Month as Assessed by Depression Anxiety Stress Scale-21 (DASS-21)', 'timeFrame': 'From enrollment to the end of intervention at 1 week and follow-up at 1 month', 'description': 'Higher points are equivalent to higher symptoms as assessed by the related subscale of DASS-21. Each subscale ranges from 0 to 28.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dialectical Behavior Therapy', 'Skills Training', 'Suicide ideation', 'Randomized'], 'conditions': ['Suicide Ideation', 'Coping Skills', 'Emotion Regulation']}, 'descriptionModule': {'briefSummary': "The goal of this clinical trial is to learn if Brief Dialectical Behavior Therapy Skills Training (DBT-BST) can prevent suicidality in adults. The main questions it aims to answer are:\n\n* Does DBT-BST provide coping strategies (e.g., emotion regulation) to participants with suicidal ideation?\n* Does DBT-BST lower participants' suicide ideation?\n\nResearchers will compare DBT-BST to relaxation to see if DBT-BST works to reduce suicidal ideation.\n\nParticipants will:\n\n* Receive DBT-BST in a single 60-minute, in-person, individual session.\n* Be asked to use these skills as self-help and for crisis prevention."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* being 18 years of age or older\n* having suicidal ideation in the last 3 months\n* not having received any psychological treatment in the last 1 month\n* living in Aydın/Türkiye where the intervention will be implemented\n* giving consent for participation\n\nExclusion Criteria:\n\n* not speaking Turkish\n* loss or trauma in the last 1 year\n* pharmacological treatment'}, 'identificationModule': {'nctId': 'NCT07039058', 'briefTitle': 'Brief DBT Skills Training for Coping With Suicidal Ideation', 'organization': {'class': 'OTHER', 'fullName': 'Aydin Adnan Menderes University'}, 'officialTitle': 'Brief Dialectical Behavior Therapy-Skills Training for Coping With Suicidal Ideation: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'BriefDBT-ST30/05/2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Brief Dialectical Behavior Therapy-Skills Training', 'interventionNames': ['Behavioral: Brief Dialectical Behavior Therapy-Skills Training']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Relaxation control group', 'interventionNames': ['Behavioral: Relaxation']}], 'interventions': [{'name': 'Brief Dialectical Behavior Therapy-Skills Training', 'type': 'BEHAVIORAL', 'description': 'The intervention is administered in a single session, lasting approximately 60 minutes and conducted in person. It is important to note that there are no ongoing sessions.\n\nIn the intervention, participants are provided with 5 basic skills of Dialectical Behavior Therapy: 1) mindfulness, 2) mindfulness of current emotions, 3) opposite-to-emotion action, 4) distraction, and 5) changing body chemistry. These strategies are grouped under 3 categories: 1) Mindfulness, 2) Emotion regulation (mindfulness of current emotions, opposite-to-emotion action), 3) Tolerating distress (distraction, changing body chemistry). These skills are not designed to treat or solve the crisis. The main aim is to provide effective coping mechanisms that can be implemented quickly before the crisis escelates, to help overcome the intense emotional pain and keep the person alive.', 'armGroupLabels': ['Brief Dialectical Behavior Therapy-Skills Training']}, {'name': 'Relaxation', 'type': 'BEHAVIORAL', 'description': 'The control group will be subjected to a relaxation exercise, with the objective of managing participant expectations, researcher attention/interest, and time spent, as well as providing a coping strategy for stress.', 'armGroupLabels': ['Relaxation control group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '09500', 'city': 'Aydin', 'state': 'Aydın', 'country': 'Turkey (Türkiye)', 'facility': 'Aydın Adnan Menderes University, Suicide and Stress Research Laboratory', 'geoPoint': {'lat': 37.84501, 'lon': 27.83963}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Muhammed Ali Boztepe', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': "Clinical Psychology Master's Student", 'investigatorFullName': 'Muhammed Ali Boztepe', 'investigatorAffiliation': 'Aydin Adnan Menderes University'}}}}