Ignite Creation Date:
2025-12-24 @ 5:53 PM
Ignite Modification Date:
2026-01-01 @ 8:31 AM
Study NCT ID:
NCT06497868
Status:
RECRUITING
Last Update Posted:
2024-07-12
First Post:
2024-07-01
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Self-compassion and Bipolar Disorder
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001714', 'term': 'Bipolar Disorder'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D000080103', 'term': 'Emotional Regulation'}], 'ancestors': [{'id': 'D000068105', 'term': 'Bipolar and Related Disorders'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D000068356', 'term': 'Self-Control'}, {'id': 'D012919', 'term': 'Social Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'CASE_ONLY'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-06-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-07', 'completionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-09', 'studyFirstSubmitDate': '2024-07-01', 'studyFirstSubmitQcDate': '2024-07-09', 'lastUpdatePostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-07-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06-20', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of the effectiveness of the Compassion-Based Therapy (CBT) and the Cognitive Therapy focused on Mental Imagery (mTCI).', 'timeFrame': 'Up to 1 year', 'description': 'For the evaluation of these two psychological therapies targeting self-compassion, the Self Compassion Scale (SCS; Neff, 2003) will be used :\n\n* The SCS is a 26-question self-assessment questionnaire with a response format of 5-point Likert type (from 1= almost never to 5= almost always).\n* The score between :\n\n * 1.0-2.49 is considered to be low,\n * 2.5-3.5 is considered to be moderate,\n * 3.51-5.0 is considered to be high.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Bipolar Disorder', 'Self-compassion', 'cognitive-behavioral therapy', 'Anxiety Disorders', 'Depressive Disorder', 'Emotional regulation', 'Mental Imagery'], 'conditions': ['Bipolar Disorder']}, 'descriptionModule': {'briefSummary': 'Currently, pharmacotherapy is central in the management of bipolar disorder (BD), but does not guarantee satisfactory results for many patients. Existing psychotherapies, notably cognitive-behavioral therapy (CBT), show some effectiveness, but do not target the mechanisms that maintain the disorder. Indeed, people with BD present a low level of self-compassion, suffer from comorbidities (e.g. anxiety, depression), and have a high level of emotional dysregulation, which can contribute to increasing the risk of relapse and mood instability.\n\nIn this context, it has been suggested that interventions targeting self-compassion could reduce BD psychopathology and strengthen emotional regulation skills.\n\nTwo psychological therapies targeting self-compassion could be promising in the treatment of BD: Compassion-Based Therapy (CBT) and Cognitive Therapy focused on Mental Imagery (mTCI). These approaches partly emphasize compassionate mental imagery to promote self-soothing and emotion management skills.\n\nStudies on the feasibility and effectiveness of CBT and mTCI in the context of BD are few in number, and do not focus on their impact on emotional regulation abilities. Evaluating these therapies could lead to the development of more specific and effective interventions for people with TB.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Major subject (≥ 18 years old) with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from January 1, 2022 to February 29, 2024.', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Major subject (≥ 18 years old)\n* Subject with diagnosed bipolar disorder followed on an outpatient basis, in a day hospital or outside the hospital during the period from January 1, 2022 to February 29, 2024.\n* Absence of written opposition in the subject's medical file to the reuse of their data for scientific research purposes.\n\nExclusion Criteria:\n\n* Subject having expressed his opposition to the reuse of his data for scientific research purposes.\n* Judicial measures: care under constraint or patient deprived of liberty due to a legal measure"}, 'identificationModule': {'nctId': 'NCT06497868', 'acronym': 'COMPASS-TB', 'briefTitle': 'Self-compassion and Bipolar Disorder', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Strasbourg, France'}, 'officialTitle': 'Self-compassion and Bipolar Disorder: Evaluation of the Feasibility and Preliminary Effectiveness of Two Psychological Therapies Targeting Self-compassion', 'orgStudyIdInfo': {'id': '9243'}}, 'contactsLocationsModule': {'locations': [{'zip': '67091', 'city': 'Strasbourg', 'state': 'Les Hôpitaux Universitaires de Strasbourg', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Luisa WEINER, Psychologist', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Emilie CHARLES, Psychologist', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Service de Psychiatrie - CHU de Strasbourg - France', 'geoPoint': {'lat': 48.58392, 'lon': 7.74553}}], 'centralContacts': [{'name': 'Luisa WEINER, PhD', 'role': 'CONTACT', 'email': 'luisa.weiner@chru-strasbourg.fr', 'phone': '33 3 88 11 65 11'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Strasbourg, France', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}