Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT04689867
Status:
COMPLETED
Last Update Posted:
2023-04-24
First Post:
2020-12-22
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D013405', 'term': 'Suicide'}, {'id': 'D011618', 'term': 'Psychotic Disorders'}, {'id': 'D000092864', 'term': 'Suicide Prevention'}], 'ancestors': [{'id': 'D016728', 'term': 'Self-Injurious Behavior'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}, {'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'bornheim@umich.edu', 'phone': '(734) 615-2915', 'title': 'Lindsay Bornheimer', 'organization': 'University of Michigan'}, 'certainAgreement': {'piSponsorEmployee': True, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': 'This was an open pilot trial, therefore no randomization occurred nor comparison between receiving treatment or not. All participants received treatment. The next phase of our study (Aim 2; registered separately) will report on the RCT.'}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data collected across participant involvement in study (beginning with the eligibility screener and ending after follow-up assessment): Approximately across 5 months per participant', 'description': 'Systematic Assessment of Adverse Events: Routine determination of adverse events through standard assessment at each study timepoints by research staff, project coordinator, or principal investigator.', 'eventGroups': [{'id': 'EG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis.\n\nIn this open pilot trial, all participants received the treatment.', 'otherNumAtRisk': 5, 'deathsNumAtRisk': 5, 'otherNumAffected': 1, 'seriousNumAtRisk': 5, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Anxiety during assessment', 'stats': [{'groupId': 'EG000', 'numAtRisk': 5, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Calgary Depression Rating Scale (CDRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '13.60', 'spread': '5.73', 'groupId': 'OG000'}]}]}, {'title': 'mid-treatment', 'categories': [{'measurements': [{'value': '9.00', 'spread': '2.92', 'groupId': 'OG000'}]}]}, {'title': 'post-treatment', 'categories': [{'measurements': [{'value': '11.00', 'spread': '2.58', 'groupId': 'OG000'}]}]}, {'title': 'follow-up', 'categories': [{'measurements': [{'value': '7.60', 'spread': '3.65', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Positive and Negative Symptom Rating Scale (PANSS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis'}], 'classes': [{'title': 'Baseline positive sub scale', 'categories': [{'measurements': [{'value': '20.20', 'spread': '3.27', 'groupId': 'OG000'}]}]}, {'title': 'Baseline negative sub scale', 'categories': [{'measurements': [{'value': '18.20', 'spread': '5.89', 'groupId': 'OG000'}]}]}, {'title': 'Baseline general sub scale', 'categories': [{'measurements': [{'value': '42.40', 'spread': '7.96', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment positive sub scale', 'categories': [{'measurements': [{'value': '20.40', 'spread': '4.16', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment negative sub scale', 'categories': [{'measurements': [{'value': '19.00', 'spread': '7.81', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment general sub scale', 'categories': [{'measurements': [{'value': '41.20', 'spread': '8.53', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment positive sub scale', 'categories': [{'measurements': [{'value': '20.00', 'spread': '7.62', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment negative sub scale', 'categories': [{'measurements': [{'value': '17.75', 'spread': '6.40', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment general sub scale', 'categories': [{'measurements': [{'value': '37.50', 'spread': '10.38', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up positive sub scale', 'categories': [{'measurements': [{'value': '20.80', 'spread': '7.66', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up negative sub scale', 'categories': [{'measurements': [{'value': '18.00', 'spread': '8.25', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up general sub scale', 'categories': [{'measurements': [{'value': '43.4', 'spread': '12.42', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis'}], 'classes': [{'title': 'Baseline suicide ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Baseline suicide plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Baseline suicide attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment suicide ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment suicide plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment suicide attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment suicide ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment suicide plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '1', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment suicide attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '4', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '4', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up suicide ideation', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up suicide plan', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '2', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '3', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up suicide attempt', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'OG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'OG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure suicide thoughts and behavior.\n\nThe following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death.\n\nA numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent)', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'One individual at post-treatment did not complete the assessment with research staff'}, {'type': 'SECONDARY', 'title': 'Beck Hopelessness Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '12.80', 'spread': '8.17', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment', 'categories': [{'measurements': [{'value': '10.40', 'spread': '8.76', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '12.00', 'spread': '7.44', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '9.80', 'spread': '8.87', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Entrapment Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '35.80', 'spread': '15.61', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment', 'categories': [{'measurements': [{'value': '30.40', 'spread': '21.10', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '28.75', 'spread': '18.39', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '36.0', 'spread': '21.09', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'The Defeat Scale', 'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '43.00', 'spread': '18.41', 'groupId': 'OG000'}]}]}, {'title': 'Mid-treatment', 'categories': [{'measurements': [{'value': '40.40', 'spread': '20.62', 'groupId': 'OG000'}]}]}, {'title': 'Post-treatment', 'categories': [{'measurements': [{'value': '39.00', 'spread': '15.43', 'groupId': 'OG000'}]}]}, {'title': 'Follow-up', 'categories': [{'measurements': [{'value': '41.5', 'spread': '14.27', 'groupId': 'OG000'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis.\n\nIn this open pilot trial, all participants received the treatment.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}]}]}], 'preAssignmentDetails': 'A total of eight clients consented to participate in the Aim 1 open pilot study and were subsequently scheduled to attend a screening assessment. One individual was not eligible per the screening assessment, and two individuals did not attend the scheduled screening assessment.\n\nAs a result, five individuals were eligible to participate and began treatment.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '5', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.\n\nCognitive Behavioral Suicide Prevention for psychosis CBSPp): Cognitive and behavioral approach to suicide prevention among individuals with psychosis'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '44.66', 'spread': '13.06', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Asian', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}, {'title': 'White', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'Lifetime History of Suicide Attempt', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '4', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '1', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Week Suicide Attempt', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '5', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Week Suicide Ideation', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Past Week Suicide Plan', 'classes': [{'categories': [{'title': 'Yes', 'measurements': [{'value': '3', 'groupId': 'BG000'}]}, {'title': 'No', 'measurements': [{'value': '2', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-12-10', 'size': 432568, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2023-03-05T12:26', 'hasProtocol': True}, {'date': '2021-12-10', 'size': 228330, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2023-03-03T10:48', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-04', 'completionDateStruct': {'date': '2022-04-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-04-02', 'studyFirstSubmitDate': '2020-12-22', 'resultsFirstSubmitDate': '2023-03-05', 'studyFirstSubmitQcDate': '2020-12-29', 'lastUpdatePostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-04-02', 'studyFirstPostDateStruct': {'date': '2020-12-30', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-04-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-04-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calgary Depression Rating Scale (CDRS)', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure depression with scores ranging from 0 to 27 and greater scores indicating greater depression. Item 8 of the scale measures suicide thoughts and behaviors.'}, {'measure': 'Positive and Negative Symptom Rating Scale (PANSS)', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure psychosis with item ratings ranging from 1 to 7. There are 3 sub-scales across 30 questions of the full scale: positive symptom scale (score range 7-49), negative symptom scale (score range 7-49), and general symptom scale (score range 16-112). Scores are summed for each of the 3 sub-scales with higher scores indicating greater presence of symptoms.'}, {'measure': 'Columbia-Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure suicide thoughts and behavior.\n\nThe following are C-SSRS items that have binary responses (yes/no): wish to be dead, non-specific active suicidal thoughts, active suicidal ideation with some intent to act and without specific plan, active suicidal ideation with specific plan and intent, preparatory acts or behavior, aborted attempt, interrupted attempt, actual attempt (non-fatal), and suicide death.\n\nA numerical suicidal ideation score is assigned for the first 5 binary items ranging from 0 (no ideation) to 5 (active ideation with plan and intent)'}], 'secondaryOutcomes': [{'measure': 'Beck Hopelessness Scale', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure hopelessness using 20 items with binary (true/false) response categories. Scores are summed and range from 0-20, higher scores indicate greater hopelessness is present.'}, {'measure': 'The Entrapment Scale', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure entrapment using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, and higher scores indicate greater feelings of being entrapped.'}, {'measure': 'The Defeat Scale', 'timeFrame': 'baseline, mid-treatment (week 5 of treatment), post-treatment (week 10 of treatment), follow-up (2 months after week 10 of treatment)', 'description': 'A scale to measure defeat using 16 items and response categories ranging from 0 to 4. Scores are summed with a range of 0 to 64, higher scores indicate greater feelings of being defeated.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['cognitive behavioral therapy', 'suicide prevention', 'community mental health'], 'conditions': ['Suicide', 'Psychosis']}, 'descriptionModule': {'briefSummary': 'The investigators are modifying and testing the preliminary effectiveness and implementation of a Cognitive Behavioral Suicide Prevention for psychosis (CBSPp) intervention. In this phase of the study, CBSPp will be tested in an initial open trial (n = 10) to examine its feasibility and acceptability. Investigators will recruit clients receiving services at a community mental health setting who have a schizophrenia spectrum disorder and recent suicidal thoughts and behaviors to receive the behavioral intervention for 10-weeks. Providers will be recruited and trained to deliver the intervention. Both clients and providers will be assessed at baseline to test our approach to measurement prior to the Aim 2 RCT (registered separately). Clients will be assessed at three additional timepoints (middle of treatment, end of treatment, and 2 months after treatment ends.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Schizophrenia Spectrum Disorder\n* Suicide ideation and/or attempt within 3 months of screening\n* Ability to speak and read in English\n* 18 to 65 years of age\n\nExclusion Criteria:\n\n* Requiring emergency care (e.g. imminent plan to harm self) as determined by trained research staff administering the Columbia-Suicide Severity Rating Scale (C-SSRS)\n* Inappropriate for behavioral treatment according to own judgment in consultation with a treating clinician CMH\n* Impaired capacity (cognitive capacity)'}, 'identificationModule': {'nctId': 'NCT04689867', 'briefTitle': 'Cognitive Behavioral Suicide Prevention for Psychosis: Aim 1', 'organization': {'class': 'OTHER', 'fullName': 'University of Michigan'}, 'officialTitle': 'Feasibility, Acceptability, and Preliminary Effectiveness of a Cognitive-behavioral Suicide Prevention-focused Intervention Tailored to Adults Diagnosed With Schizophrenia Spectrum Disorders: Aim 1 Open Pilot Trial to Test Modified Treatment and Measurement Prior to Aim 2 RCT (Registered Separately)', 'orgStudyIdInfo': {'id': 'HUM00152247'}, 'secondaryIdInfos': [{'id': 'R34MH123609', 'link': 'https://reporter.nih.gov/quickSearch/R34MH123609', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'CBSPp', 'description': 'Cognitive Behavioral Suicide Prevention for psychosis is a behavioral treatment and will be delivered in 10 weekly individual therapy sessions.', 'interventionNames': ['Behavioral: Cognitive Behavioral Suicide Prevention for psychosis CBSPp)']}], 'interventions': [{'name': 'Cognitive Behavioral Suicide Prevention for psychosis CBSPp)', 'type': 'BEHAVIORAL', 'description': 'Cognitive and behavioral approach to suicide prevention among individuals with psychosis', 'armGroupLabels': ['CBSPp']}]}, 'contactsLocationsModule': {'locations': [{'zip': '48109', 'city': 'Ann Arbor', 'state': 'Michigan', 'country': 'United States', 'facility': 'University of Michigan', 'geoPoint': {'lat': 42.27756, 'lon': -83.74088}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Upload to NIMH Data Archive'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Michigan', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Mental Health (NIMH)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Lindsay Bornheimer', 'investigatorAffiliation': 'University of Michigan'}}}}