Ignite Creation Date:
2025-12-25 @ 1:26 AM
Ignite Modification Date:
2026-02-24 @ 5:08 AM
Study NCT ID:
NCT01881893
Status:
COMPLETED
Last Update Posted:
2015-12-24
First Post:
2013-05-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 42}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-23', 'studyFirstSubmitDate': '2013-05-31', 'studyFirstSubmitQcDate': '2013-06-17', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-06-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Psychosocial Outcome Measures: Change in depression and anxiety symptoms', 'timeFrame': 'Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up', 'description': 'Symptoms of anxiety and depression will be assessed using the Hospital Anxiety and Depression Scale (HADS)'}], 'secondaryOutcomes': [{'measure': 'Psychological Outcome Measures: Social functioning', 'timeFrame': 'Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up', 'description': 'Two metrics will be used to assess social functioning; the Social Functioning subscale of the Short Form Health Status Survey (SF-12v2) and the Enhanced Recovery in Coronary Heart Disease (ENRICHD) Social Support Inventory (ESSI).'}, {'measure': 'Psychosocial Outcome Measures: Resilience', 'timeFrame': 'Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up', 'description': 'This psychosocial outcome will be measured by the Resilience Scale (RS).'}, {'measure': 'Psychosocial Outcome Measures: Quality of Life and health status', 'timeFrame': 'Prior to randomization (baseline), immediately following the completion of the ACHD-CARE program or Usual Care period, and at three months follow-up', 'description': 'The quality of life of the participants will be measured using the Satisfaction with Life Scales (SWLS) and the Linear Analogue Scale (LAS). Health status will be assessed using the SF-12v2.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Quality of life', 'Psychosocial Support Systems', 'Randomized Controls as Topic', 'Cognitive Therapy', 'Feasibility Studies'], 'conditions': ['Heart Defects, Congenital']}, 'descriptionModule': {'briefSummary': 'The psychosocial development of adults with congenital heart disease (CHD) can be challenged by many issues including family overprotection, impaired peer relationships, delayed progression into independent adulthood, and difficulties with career and future planning. One-third of patients have diagnosable mood or anxiety disorders and the prevalence of depression is 3 times that of the general Canadian population. Unfortunately, most adults with CHD and significant depression or anxiety do not receive mental health treatment. Despite an increasing awareness of the unique psychosocial concerns of this patient population by both health care providers and patients, there have been no interventions targeting psychosocial outcomes in the adult CHD population. Our quantitative and qualitative research suggests that patients themselves are very interested in psychological services that target their distinctive life experiences, are provided in a group setting, and emphasize coping and resilience. The overarching aim of this proposal is to assess the feasibility of a full-scale randomized controlled trial of a group intervention aimed at improving the psychosocial functioning, quality of life, and resilience of adults with CHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Documented congenital heart disease (CHD), as confirmed by echocardiogram, cardiac catheterization, or previous surgery\n* Age greater than or equal to 18 years\n* English-language proficiency sufficient to read and complete the consent form and questionnaires and participate in an English-language group\n* No planned surgery during patient's participation in the study\n* Clinically-elevated score (i.e \\>=8) on the Hospital Anxiety and Depression Scale depression (HADS-D) or anxiety (HADS-A) subscale\n\nExclusion Criteria:\n\n* Current psychotherapy or pharmacotherapy\n* Significant cognitive impairment, psychosis, or personality disorder as documented in medical chart\n* Report of suicidal intent during screening"}, 'identificationModule': {'nctId': 'NCT01881893', 'acronym': 'ACHD-CARE', 'briefTitle': 'Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial', 'organization': {'class': 'OTHER', 'fullName': 'University Health Network, Toronto'}, 'officialTitle': 'Feasibility Study of the Adult Congenital Heart Disease-Coping and Resilience (ACHD-CARE) Trial', 'orgStudyIdInfo': {'id': 'MOP 123251'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Usual Care', 'description': 'Patients in this arm of the study will continue to receive their regular level of care.'}, {'type': 'EXPERIMENTAL', 'label': 'ACHD-CARE Program', 'description': 'Group based psychosocial intervention.\n\n* Educational: congenital heart disease information\n* Behavioral: cognitive behavioral therapy\n* Behavioral: social interactions and communication skills', 'interventionNames': ['Behavioral: ACHD-CARE Program']}], 'interventions': [{'name': 'ACHD-CARE Program', 'type': 'BEHAVIORAL', 'description': 'The ACHD-CARE program will be provided in eight 90-minute weekly sessions. The intervention includes information about living with congenital heart disease, cognitive behavioral therapy (CBT) and coping techniques, and opportunities for peer interaction.', 'armGroupLabels': ['ACHD-CARE Program']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G 2N2', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Toronto Congenital Cardiac Clinic for Adults, Peter Munk Cardiac Centre, Toronto General Hospital', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Adrienne H Kovacs, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, Toronto'}, {'name': 'Jane Irvine, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Health Network, York University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Health Network, Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}