Ignite Creation Date:
2025-12-24 @ 4:46 PM
Ignite Modification Date:
2026-01-31 @ 1:40 PM
Study NCT ID:
NCT01935050
Status:
COMPLETED
Last Update Posted:
2017-12-12
First Post:
2013-05-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Guided Self-Help for Depression in Parkinson's Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003863', 'term': 'Depression'}, {'id': 'D010300', 'term': 'Parkinson Disease'}], 'ancestors': [{'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D020734', 'term': 'Parkinsonian Disorders'}, {'id': 'D001480', 'term': 'Basal Ganglia Diseases'}, {'id': 'D001927', 'term': 'Brain Diseases'}, {'id': 'D002493', 'term': 'Central Nervous System Diseases'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D009069', 'term': 'Movement Disorders'}, {'id': 'D000080874', 'term': 'Synucleinopathies'}, {'id': 'D019636', 'term': 'Neurodegenerative Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-10', 'studyFirstSubmitDate': '2013-05-29', 'studyFirstSubmitQcDate': '2013-08-29', 'lastUpdatePostDateStruct': {'date': '2017-12-12', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-09-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The Hamilton Depression Rating Scale', 'timeFrame': '14 weeks', 'description': 'A clinician-administered rating scale for depression'}], 'secondaryOutcomes': [{'measure': 'Beck Depression Inventory', 'timeFrame': '14 weeks', 'description': 'A self-report measure of depression'}, {'measure': 'Hamilton Anxiety Rating Scale', 'timeFrame': '14 weeks', 'description': 'A clinician-administered rating scale of anxiety'}, {'measure': 'Inference Questionnaire', 'timeFrame': '14 weeks', 'description': 'Self-report measure of negative thoughts'}, {'measure': 'Caregiver Distress Scale', 'timeFrame': '14 weeks', 'description': 'Self-report measure of caregiver stress'}, {'measure': 'Insomnia Severity Index', 'timeFrame': '14 weeks', 'description': 'Self-report sleep scale'}, {'measure': 'Medical Outcomes Short Form', 'timeFrame': '14 weeks', 'description': 'Self-report quality of life scale'}, {'measure': 'Feasibility and adherence measures', 'timeFrame': '10 weeks', 'description': 'Feasibility \\[Likert ratings (0-10) on the dimensions of readability, clarity, effort, enjoyment, fatigue, helpfulness, and progress regarding treatment materials\\] and adherence measures \\[a numerical rating regarding the % of recommended activities accomplished\\]'}, {'measure': 'Clinical Global Impression-Improvement Scale', 'timeFrame': '14 weeks', 'description': 'Clinician-rated scale of depression improvement'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Depression', "Parkinson's disease", 'Cognitive-Behavioral Treatment'], 'conditions': ['Depression', "Parkinson's Disease"]}, 'descriptionModule': {'briefSummary': "The purpose of this project is to develop and pilot-test a guided cognitive-behavioral self-help program for mild-to-moderate depression in Parkinson's disease (dPD). We will pilot-test the guided self-help treatment on 20 people with PD and their caregivers. The manual will be revised based on participant feedback. Several feasibility measures regarding the guided self-help program (i.e., recruitment, retention, enjoyment, helpfulness, adherence) will also be assessed. Moreover, preliminary estimates of effect size for this guided self-help program will be calculated and used in future research. We hypothesize that people with PD will report decreases in depression, anxiety, and negative thoughts and improvements in quality life and sleep and that caregivers will report decreases in burden after participating in the guided self-help program", 'detailedDescription': 'To our knowledge, Cognitive-Behavioral self-help interventions remain unexplored for depression in PD to date. The results of this study will be used to support future treatment development efforts for depression and other psychiatric complications in PD that may improve the access to and quality of mental health care in this medical population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Previous diagnosis of Parkinson's disease by a general neurologist or Movement Disorders Specialist\n2. Clinically significant depression as determined by study staff\n3. 35-85 years old\n4. Stable medication regimen ≥ 6 weeks\n5. No change in mental health treatment in past 2 months \\_\n\nExclusion Criteria:\n\n1. Severe depressive symptoms\n2. Suicidal plans or intent\n3. Significant cognitive impairment\n4. Significant motor fluctuations (i.e., ≥ 50% of the day)\n5. Unstable medical conditions\n6. Receiving CBT elsewhere"}, 'identificationModule': {'nctId': 'NCT01935050', 'briefTitle': "Guided Self-Help for Depression in Parkinson's Disease", 'organization': {'class': 'OTHER', 'fullName': 'Rutgers, The State University of New Jersey'}, 'officialTitle': "A Guided Cognitive-Behavioral Self-Help Treatment for Depression in Parkinson's Disease", 'orgStudyIdInfo': {'id': '2013002798'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Guided Cognitive-Behavioral Self-Help', 'description': "All participants will receive the experimental intervention: Guided Cognitive-Behavioral Self-Help. The 10 patient treatment modules will incorporate exercise, behavioral activation, thought monitoring and restructuring, relaxation training, worry control, and sleep hygiene. The four caregiver educational modules will provide caregivers with the skills needed to facilitate patients' practice of treatment techniques learned in session. For example, caregivers will be taught to help patients identify negative thoughts and replace them with more balanced alternatives and will be given tools to assist patients complete therapy goals (i.e., exercise, socializing).", 'interventionNames': ['Behavioral: Guided Cognitive-Behavioral Self-Help']}], 'interventions': [{'name': 'Guided Cognitive-Behavioral Self-Help', 'type': 'BEHAVIORAL', 'description': 'Participants will complete the study treatment at home. Bi-weekly telephone support will be provided by study staff.', 'armGroupLabels': ['Guided Cognitive-Behavioral Self-Help']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08854', 'city': 'Piscataway', 'state': 'New Jersey', 'country': 'United States', 'facility': 'Rutgers University-Robert Wood Johnson Medical School', 'geoPoint': {'lat': 40.49927, 'lon': -74.39904}}], 'overallOfficials': [{'name': 'Roseanne D Dobkin, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rutgers Robert Wood Johnson Medical School'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rutgers, The State University of New Jersey', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor of Psychiatry', 'investigatorFullName': 'Roseanne D Dobkin, PhD', 'investigatorAffiliation': 'Rutgers, The State University of New Jersey'}}}}