Ignite Creation Date:
2025-12-25 @ 5:11 AM
Ignite Modification Date:
2025-12-26 @ 4:16 AM
Study NCT ID:
NCT03368027
Status:
COMPLETED
Last Update Posted:
2020-02-17
First Post:
2017-12-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014786', 'term': 'Vision Disorders'}, {'id': 'D013315', 'term': 'Stress, Psychological'}, {'id': 'D000987', 'term': 'Antisocial Personality Disorder'}], 'ancestors': [{'id': 'D012678', 'term': 'Sensation Disorders'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D005128', 'term': 'Eye Diseases'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D010554', 'term': 'Personality Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D035061', 'term': 'Control Groups'}], 'ancestors': [{'id': 'D015340', 'term': 'Epidemiologic Research Design'}, {'id': 'D004812', 'term': 'Epidemiologic Methods'}, {'id': 'D008919', 'term': 'Investigative Techniques'}, {'id': 'D012107', 'term': 'Research Design'}, {'id': 'D008722', 'term': 'Methods'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-02', 'completionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-13', 'studyFirstSubmitDate': '2017-12-05', 'studyFirstSubmitQcDate': '2017-12-05', 'lastUpdatePostDateStruct': {'date': '2020-02-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-12-11', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-12-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline in vulnerability to stress at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': 'This scale registeres the aspects that influence the ability to deal with stress'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline in Perceived stress scale at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': "This scale evaluates the degree to which situations in one's life are appraised as stressful"}, {'measure': 'Change from Baseline in Symptom Checklist-90-Revised Questionnaire at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': 'This instrument is a 90-item self-report symptom inventory developed by Leonard R. Derogatis in the mid-1970s to measure psychological symptoms and psychological distress.'}, {'measure': 'Change from Baseline in General Self efficacy scale at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': "This scale assesses people's stable believe about their ability to appropriately manage a wide kind of life stressors"}, {'measure': 'Change from Baseline in Connor-Davidson Resilience Scale at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': 'This scale evaluates stress coping ability.'}, {'measure': 'Change from Baseline in Social support questionnaire at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': 'This instrument evaluates perceived Social support.'}, {'measure': 'Change from Baseline in Visual Field Test at 12 weeks', 'timeFrame': 'Twelve weeks', 'description': 'This method evaluates the visual field of two eyes'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vision Disorders; Stress, Psychological'], 'conditions': ['Vision Disorders', 'Stress, Psychological', 'Psychopathy', 'Self Efficacy']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to evaluate the efficacy of cognitive - behavioral therapy for the control of psychopathological stress and the disease of people with Retinitis Pigmentosa (RP).', 'detailedDescription': 'This randomized controlled trial aims to evaluate the efficacy of cognitive - behavioral therapy for the control of psychopathological stress and the disease of people with Retinitis Pigmentosa (RP) on aspects such as vulnerability to stress, perceived stress, psychopathological state, general self-efficacy, resilience, satisfaction with social support and visual field. This study has two groups: 1) cognitive - behavioral therapy group, and 2) Standard intervention or control group. The two interventions will be conducted for 3 months (with a total of 12 sessions), one session per week, with a duration of 90 minutes per session.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diagnosed with Retinitis Pigmentosa (legally blind RP patients).\n* meet the membership criteria of the Spanish National Association of ONCE.\n* having a reduction of the visual field of at least 10 degrees in both eyes\n* having an age between 18 and 65 years.\n\nExclusion Criteria:\n\n* no visual remainders (advanced retinosis).\n* no studies.\n* cognitive impairment, determined by the Spanish Mini-Mental State Examination - MMSE test.\n* mobility problems\n* high risk of falls associated with retinosis, measured by the Morse scale, with a score over 50 points.'}, 'identificationModule': {'nctId': 'NCT03368027', 'acronym': 'RCT', 'briefTitle': 'Effectiveness of a Cognitive-behavioral Program of Coping With Psychological Stress in People With Retinitis Pigmentosa', 'organization': {'class': 'OTHER', 'fullName': 'Universidad de Granada'}, 'officialTitle': 'Effectiveness of a Program for Coping With Psychological Stress on Stress, Psychopathology, Self-efficacy, Resilience, Social Support and Visual Field in People With Retinitis Pigmentosa', 'orgStudyIdInfo': {'id': 'Retinitis pigmentosa RCT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Stress management program', 'description': 'A cognitive-behavioral program of coping with psychological stress for 3 months (with a total of 12 sessions), one session per week, with a duration of 90 minutes per session.', 'interventionNames': ['Behavioral: A cognitive-behavioral intervention program']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard intervention', 'description': 'Usual activities performed in the association where they attend (supervised by a psychologist) for 3 months (with a total of 12 sessions), one session per week, with a duration of 90 minutes per session.', 'interventionNames': ['Other: Standard intervention']}], 'interventions': [{'name': 'A cognitive-behavioral intervention program', 'type': 'BEHAVIORAL', 'otherNames': ['Cognitive-behavioral program'], 'description': 'In this program, participants receive a training of assertive skills, social skills, acceptance, among other psychological aspects.', 'armGroupLabels': ['Stress management program']}, {'name': 'Standard intervention', 'type': 'OTHER', 'otherNames': ['Control group'], 'description': 'Participants receive different activities conducted by a psychologist in the association where the attend.', 'armGroupLabels': ['Standard intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': '18016', 'city': 'Granada', 'country': 'Spain', 'facility': 'José Manuel Pérez Mármol', 'geoPoint': {'lat': 37.18817, 'lon': -3.60667}}], 'overallOfficials': [{'name': 'José Manuel Pérez Mármol, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Physiotherapy. Faculty of Health Sciences, University of Granada'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universidad de Granada', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'José Manuel Pérez Mármol', 'investigatorAffiliation': 'Universidad de Granada'}}}}