Ignite Creation Date:
2025-12-25 @ 2:13 AM
Ignite Modification Date:
2025-12-26 @ 5:38 PM
Study NCT ID:
NCT04711460
Status:
COMPLETED
Last Update Posted:
2024-02-02
First Post:
2020-12-15
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011618', 'term': 'Psychotic Disorders'}], 'ancestors': [{'id': 'D019967', 'term': 'Schizophrenia Spectrum and Other Psychotic Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'Lund1687@umn.edu', 'phone': '612-273-9115', 'title': 'Joan D. Lund', 'organization': 'University of MN'}, 'certainAgreement': {'piSponsorEmployee': True}, 'limitationsAndCaveats': {'description': 'Limitations and caveats include the sample size. If a larger data base was collected, more significant results may have occurred. Data collection assumes that all participants will answer honestly on both scales. The financial resources and equipment were limited to what the author provided, as there were no grants. The setting was a group room, and some participants may prefer to be outside or be alone.'}}, 'adverseEventsModule': {'timeFrame': 'Data was collected over two years to obtain results for the groups.', 'description': 'Data was collected over two years to obtain results for the groups. All-Cause Mortality, Serious, and Other \\[Not Including Serious\\] Adverse Events were not monitored/assessed', 'eventGroups': [{'id': 'EG000', 'title': '1: The TAU Group / TAU vs TAU + TX', 'description': 'The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT) and did not practice the Mindfulness as a group.', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'The TAU + TX Group / TAU vs TAU + TX', 'description': 'The TAU plus Mindfulness Training received CBT and Mindfulness Training, which included practice as a group', 'otherNumAtRisk': 32, 'deathsNumAtRisk': 32, 'otherNumAffected': 0, 'seriousNumAtRisk': 32, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Younger Participants / Younger vs Older Scores', 'description': 'Younger vs Older participant scores were compared on pre/post-test scores', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG003', 'title': 'Older Participants / Younger vs Older Scores', 'description': 'Younger vs Older participant pre/post-test scores were compared', 'otherNumAtRisk': 26, 'deathsNumAtRisk': 26, 'otherNumAffected': 0, 'seriousNumAtRisk': 26, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual', 'description': 'The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT)'}, {'id': 'OG001', 'title': 'TAU + Mindfulness Training', 'description': 'The TAU plus Mindfulness Training received CBT and Mindfulness Training.'}, {'id': 'OG002', 'title': 'Younger Participants', 'description': 'Pre/post test scores were obtained from younger participants who received TAU + Mindfulness Training'}, {'id': 'OG003', 'title': 'Older Participants', 'description': 'Pre/post test scores were obtained from younger participants who received TAU + mindfulness training.'}], 'classes': [{'categories': [{'measurements': [{'value': '4.68', 'spread': '5.4', 'groupId': 'OG000'}, {'value': '6.28', 'spread': '5.59', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '5.39', 'groupId': 'OG002'}, {'value': '7.38', 'spread': '5.13', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.003', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '.05', 'paramValue': '0.003', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.59', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'nonInferiorityComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.'}, {'pValue': '0.009', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.009', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.59', 'estimateComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'nonInferiorityComment': 'The threshold for statistical significance was set at p=0.05. No power analysis was conducted.'}, {'pValue': '<0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.05', 'paramValue': '0.05', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_ERROR_OF_MEAN', 'dispersionValue': '0.609', 'estimateComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 'Tukey Kramer Post-Hoc', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05.', 'nonInferiorityComment': 'The Tukey Kramer Post Hoc Test q value = 0.05 threshold'}, {'pValue': '0.003', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '.05', 'paramValue': '0.05', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.13', 'estimateComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'groupDescription': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'nonInferiorityComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.'}, {'pValue': '0.454', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '0.05', 'paramValue': '0.05', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '5.07', 'estimateComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'groupDescription': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.'}], 'paramType': 'MEAN', 'timeFrame': 'Five weeks', 'description': 'The Generalized Anxiety Disorder 7-item scale (GAD-7) is a 7-item survey of how often patients are bothered by symptoms of anxiety. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.\n\nPre / Post-test scores were compared.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Generalized Anxiety Disorder 7 number of participants for two studies: Treatment as usual vs TAU + Mindfulness study and the Younger versus older study.'}, {'type': 'PRIMARY', 'title': 'Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'Treatment as Usual', 'description': 'The Treatment as usual (TAU) group received Cognitive Behavioral Therapy (CBT) only. The TAU + Mindfulness Training group received CBT and Mindfulness Training and practiced it as a group.'}, {'id': 'OG001', 'title': 'TAU + Mindfulness Training', 'description': 'The group received CBT and Mindfulness Training and practiced it as a group.'}, {'id': 'OG002', 'title': 'Younger Participants', 'description': 'Younger participants received TAU + Mindfulness Training.'}, {'id': 'OG003', 'title': 'Older Participants', 'description': 'Older participants received TAU + Mindfulness Training.'}], 'classes': [{'categories': [{'measurements': [{'value': '6.68', 'spread': '6.4', 'groupId': 'OG000'}, {'value': '6.96', 'spread': '7.19', 'groupId': 'OG001'}, {'value': '3.96', 'spread': '5.39', 'groupId': 'OG002'}, {'value': '7.38', 'spread': '5.13', 'groupId': 'OG003'}]}]}], 'analyses': [{'pValue': '0.002', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.05', 'paramValue': '0.05', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '7.194', 'estimateComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'nonInferiorityComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.'}, {'pValue': '0.054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '0.05', 'paramValue': '0.05', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.09', 'estimateComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'groupDescription': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.'}, {'pValue': '0.019', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '0.05', 'paramValue': '0.05', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.93', 'estimateComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'groupDescription': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 't-test, 2 sided', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'nonInferiorityComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.'}, {'pValue': '0.101', 'groupIds': ['OG002', 'OG003'], 'paramType': 'Mean Difference (Final Values)', 'ciNumSides': 'ONE_SIDED', 'ciPctValue': '95', 'paramValue': '0.05', 'pValueComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '6.04', 'groupDescription': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.', 'nonInferiorityComment': 'Threshold of statistically significance was set at p=0.05. No power calculation was conducted.'}], 'paramType': 'MEAN', 'timeFrame': 'Five weeks', 'description': 'The Patient Health Questionnaire (PHQ-9) is a 9-item survey of how often patients are bothered by symptoms of depression. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'The Patient Health Questionnaire-9 scale number of participants in each study: The Treatment as usual (TAU) versus TAU + Mindfulness and the Younger versus Older study.'}, {'type': 'SECONDARY', 'title': 'CAGE-Adapted to Include Drug Use (CAGE-AID)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': 'The Treatment as Usual (TAU) Group', 'description': 'The Treatment as usual (TAU) group received Cognitive Behavioral Therapy (CBT) only.'}, {'id': 'OG001', 'title': 'TAU + Mindfulness Group', 'description': 'The TAU + Mindfulness group received Cognitive Behavioral Therapy (CBT) and Mindfulness Training and practiced it with the group.'}, {'id': 'OG002', 'title': 'Younger Participants', 'description': 'Younger participants received TAU + mindfulness training.'}, {'id': 'OG003', 'title': 'Older Participants', 'description': 'Older participants received TAU + mindfulness training.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline only', 'description': 'The Cut-Annoyed-Guilty-Eye (CAGE) adapted to include drug use (CAGE-AID) is a screening tool to assess drug use. Participants are asked to answer yes (score of 1) or no (score of 0) to 4 questions about their drug use. Scores range from 0 to 4 with higher scores indicating greater substance use disorder. A score of 2 or higher indicates a problem with alcohol or drugs and is clinically significant. Outcome is reported as the number of participants who scored 2 or lower.', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The CAGE-AID was used to determine sobriety in all participants, and was done before admission to the program. Scores must be below 2 and indicate no problems with alcohol or drugs.'}, {'type': 'SECONDARY', 'title': 'The Columbia Suicide Severity Rating Scale (C-SSRS)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}], 'groups': [{'id': 'OG000', 'title': '1: The TAU Group', 'description': '1: The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT).'}, {'id': 'OG001', 'title': 'The TAU + TX Group', 'description': 'The TAU plus Mindfulness Training received CBT and Mindfulness Training.'}, {'id': 'OG002', 'title': 'Younger Participants Scores', 'description': 'Younger participants received TAU + mindfulness training.'}, {'id': 'OG003', 'title': 'Older Participants', 'description': 'Older participants received TAU + mindfulness training.'}], 'classes': [{'categories': [{'measurements': [{'value': '32', 'groupId': 'OG000'}, {'value': '32', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}, {'value': '26', 'groupId': 'OG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'baseline only', 'description': "The Columbia Suicide Severity Rating Scale, or C-SSRS, measures four constructs: the severity of ideation, the intensity of ideation, behavior, and lethality. Items are rated on a scale from 0-4: Eligible participants scored at 2 or lower.\n\n1. Only one time\n2. A few times\n3. A lot\n4. All the time\n\n0\\) Don't know/Not applicable\n\nThe Columbia was done prior to being considered for the Outpatient Mental Health program by another licensed mental health staff in another department. Only those who scored at 1-2 would be considered for Outpatient. Outcome is reported as the number of participants who score a one or two on the scale, which means they are considered safe to participate.", 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': '1: TAU', 'description': '1: The Treatment as usual (TAU) group received only Cognitive Behavioral Therapy (CBT)'}, {'id': 'FG001', 'title': 'The TAU + Treatment Group', 'description': 'The TAU plus Mindfulness Training received CBT and Mindfulness Training'}, {'id': 'FG002', 'title': 'Younger Participants', 'description': 'scores were compared on pre/post-test scores'}, {'id': 'FG003', 'title': 'Older Participants', 'description': 'pre/post-test scores were compared'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '32'}, {'groupId': 'FG001', 'numSubjects': '32'}, {'groupId': 'FG002', 'numSubjects': '26'}, {'groupId': 'FG003', 'numSubjects': '26'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '0'}, {'groupId': 'FG002', 'numSubjects': '0'}, {'groupId': 'FG003', 'numSubjects': '0'}]}]}], 'recruitmentDetails': 'There was no recruitment used for this study.', 'preAssignmentDetails': 'All participants assessed and enrolled had a DSM-V diagnosis that included psychosis. They participated twice a week for 5 weeks.\n\nPre/post-test scores were collected and compared.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}], 'groups': [{'id': 'BG000', 'title': 'Treatment as Usual CBT', 'description': 'Treatment as usual (TAU group) Participants in the "Treatment as usual" (TAU) group had Cognitive Behavioral Therapy only.'}, {'id': 'BG001', 'title': 'Treatment as Usual + Mindfulness Training', 'description': '(TAU + TX group) Participants had Cognitive Behavioral Therapy (CBT), mindfulness training'}, {'id': 'BG002', 'title': 'Younger Participants', 'description': 'Younger participants pre/post test scores were compared'}, {'id': 'BG003', 'title': 'Older Participants', 'description': 'Older participants pre/post test scores were compared'}, {'id': 'BG004', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '0', 'groupId': 'BG004'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Sex/Gender, Customized', 'classes': [{'title': 'Male', 'categories': [{'measurements': [{'value': '19', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '53', 'groupId': 'BG004'}]}]}, {'title': 'Female', 'categories': [{'measurements': [{'value': '9', 'groupId': 'BG000'}, {'value': '13', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '11', 'groupId': 'BG003'}, {'value': '39', 'groupId': 'BG004'}]}]}, {'title': 'Transgender', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '24', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Categories for gender include Male, Female, and Transgender. Participants were counted in each category.', 'unitOfMeasure': 'participants', 'populationDescription': 'Gender is defined as male, female, and transgender for each category'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'Ethnicity: Caucasian', 'categories': [{'measurements': [{'value': '20', 'groupId': 'BG000'}, {'value': '15', 'groupId': 'BG001'}, {'value': '10', 'groupId': 'BG002'}, {'value': '13', 'groupId': 'BG003'}, {'value': '58', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity: African American', 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '7', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '4', 'groupId': 'BG003'}, {'value': '22', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity: Native American', 'categories': [{'measurements': [{'value': '3', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '6', 'groupId': 'BG002'}, {'value': '3', 'groupId': 'BG003'}, {'value': '17', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity: Hispanic', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}, {'value': '1', 'groupId': 'BG003'}, {'value': '4', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity: Asian', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '5', 'groupId': 'BG003'}, {'value': '7', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity: Jewish', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '5', 'groupId': 'BG004'}]}]}, {'title': 'Ethnicity: African continent', 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}, {'value': '3', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'The number of participants in each ethnic category were counted.', 'unitOfMeasure': 'participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'United States', 'categories': [{'measurements': [{'value': '32', 'groupId': 'BG000'}, {'value': '32', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '26', 'groupId': 'BG003'}, {'value': '116', 'groupId': 'BG004'}]}]}], 'paramType': 'NUMBER', 'description': 'Participants were enrolled in an Outpatient Mental Health program in Minneapolis, Minnesota, USA.', 'unitOfMeasure': 'participants'}, {'title': 'PHQ-9 and GAD-7 Number of Participants', 'classes': [{'title': 'PHQ-9 Scores: Mean (Standard Deviation) Unit of measures: scores on a scale', 'categories': [{'measurements': [{'value': '9.32', 'spread': '6.4', 'groupId': 'BG000'}, {'value': '12.31', 'spread': '7.19', 'groupId': 'BG001'}, {'value': '11.84', 'spread': '5.9', 'groupId': 'BG002'}, {'value': '12.34', 'spread': '6.9', 'groupId': 'BG003'}, {'value': '11.45', 'spread': '6.15', 'groupId': 'BG004'}]}]}, {'title': 'GAD-7 Scores: Mean (Standard Deviation) Unit of measures: scores on a scale', 'categories': [{'measurements': [{'value': '6.25', 'spread': '5.4', 'groupId': 'BG000'}, {'value': '10.09', 'spread': '5.59', 'groupId': 'BG001'}, {'value': '9.15', 'spread': '5.39', 'groupId': 'BG002'}, {'value': '11.42', 'spread': '5.13', 'groupId': 'BG003'}, {'value': '9.23', 'spread': '5.38', 'groupId': 'BG004'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}], 'populationDescription': 'The number of participants in each study: Treatment as usual (TAU) versus TAU + Mindfulness and the Younger versus Older study.'}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2019-02-12', 'size': 619868, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2021-11-22T14:37', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 116}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-05', 'completionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-05-17', 'studyFirstSubmitDate': '2020-12-15', 'resultsFirstSubmitDate': '2021-01-26', 'studyFirstSubmitQcDate': '2021-01-12', 'lastUpdatePostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-05-17', 'studyFirstPostDateStruct': {'date': '2021-01-15', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2024-02-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-08-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Generalized Anxiety Disorder-7 Pre/Post Test at Week 5', 'timeFrame': 'Five weeks', 'description': 'The Generalized Anxiety Disorder 7-item scale (GAD-7) is a 7-item survey of how often patients are bothered by symptoms of anxiety. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.\n\nPre / Post-test scores were compared.'}, {'measure': 'Change in Patient Health Questionnaire-9 Score From Pre / Post-test at Week 5', 'timeFrame': 'Five weeks', 'description': 'The Patient Health Questionnaire (PHQ-9) is a 9-item survey of how often patients are bothered by symptoms of depression. Items are rated from 0 (not at all) to 3 (nearly every day). The total score is a sum of item scores and ranges from 0 (minimal depression) to 27 (severe depression). Outcome is reported as the change from baseline to approximately 5 weeks.'}], 'secondaryOutcomes': [{'measure': 'CAGE-Adapted to Include Drug Use (CAGE-AID)', 'timeFrame': 'baseline only', 'description': 'The Cut-Annoyed-Guilty-Eye (CAGE) adapted to include drug use (CAGE-AID) is a screening tool to assess drug use. Participants are asked to answer yes (score of 1) or no (score of 0) to 4 questions about their drug use. Scores range from 0 to 4 with higher scores indicating greater substance use disorder. A score of 2 or higher indicates a problem with alcohol or drugs and is clinically significant. Outcome is reported as the number of participants who scored 2 or lower.'}, {'measure': 'The Columbia Suicide Severity Rating Scale (C-SSRS)', 'timeFrame': 'baseline only', 'description': "The Columbia Suicide Severity Rating Scale, or C-SSRS, measures four constructs: the severity of ideation, the intensity of ideation, behavior, and lethality. Items are rated on a scale from 0-4: Eligible participants scored at 2 or lower.\n\n1. Only one time\n2. A few times\n3. A lot\n4. All the time\n\n0\\) Don't know/Not applicable\n\nThe Columbia was done prior to being considered for the Outpatient Mental Health program by another licensed mental health staff in another department. Only those who scored at 1-2 would be considered for Outpatient. Outcome is reported as the number of participants who score a one or two on the scale, which means they are considered safe to participate."}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['mindfulness', 'group therapy'], 'conditions': ['Psychosis']}, 'referencesModule': {'references': [{'pmid': '12703651', 'type': 'BACKGROUND', 'citation': 'Brown KW, Ryan RM. The benefits of being present: mindfulness and its role in psychological well-being. J Pers Soc Psychol. 2003 Apr;84(4):822-48. doi: 10.1037/0022-3514.84.4.822.'}, {'pmid': '7778330', 'type': 'BACKGROUND', 'citation': 'Brown RL, Rounds LA. Conjoint screening questionnaires for alcohol and other drug abuse: criterion validity in a primary care practice. Wis Med J. 1995;94(3):135-40.'}, {'pmid': '19545481', 'type': 'BACKGROUND', 'citation': 'Chadwick P, Hughes S, Russell D, Russell I, Dagnan D. Mindfulness groups for distressing voices and paranoia: a replication and randomized feasibility trial. Behav Cogn Psychother. 2009 Jul;37(4):403-12. doi: 10.1017/S1352465809990166. Epub 2009 Jun 23.'}, {'pmid': '24785766', 'type': 'BACKGROUND', 'citation': 'Chadwick P. Mindfulness for psychosis. Br J Psychiatry. 2014;204:333-4. doi: 10.1192/bjp.bp.113.136044.'}, {'pmid': '27146475', 'type': 'BACKGROUND', 'citation': 'Chadwick P, Strauss C, Jones AM, Kingdon D, Ellett L, Dannahy L, Hayward M. Group mindfulness-based intervention for distressing voices: A pragmatic randomised controlled trial. Schizophr Res. 2016 Aug;175(1-3):168-173. doi: 10.1016/j.schres.2016.04.001. Epub 2016 Apr 14.'}, {'pmid': '31382104', 'type': 'BACKGROUND', 'citation': 'Chadwick P. Mindfulness for psychosis: a humanising therapeutic process. Curr Opin Psychol. 2019 Aug;28:317-320. doi: 10.1016/j.copsyc.2019.07.022. Epub 2019 Jul 18.'}, {'pmid': '24809397', 'type': 'BACKGROUND', 'citation': 'Chien WT, Thompson DR. Effects of a mindfulness-based psychoeducation programme for Chinese patients with schizophrenia: 2-year follow-up. Br J Psychiatry. 2014 Jul;205(1):52-9. doi: 10.1192/bjp.bp.113.134635. Epub 2014 May 8.'}, {'pmid': '17716538', 'type': 'BACKGROUND', 'citation': 'Dhalla S, Kopec JA. The CAGE questionnaire for alcohol misuse: a review of reliability and validity studies. Clin Invest Med. 2007;30(1):33-41. doi: 10.25011/cim.v30i1.447.'}, {'pmid': '26833597', 'type': 'BACKGROUND', 'citation': 'Dixon LB, Holoshitz Y, Nossel I. Treatment engagement of individuals experiencing mental illness: review and update. World Psychiatry. 2016 Feb;15(1):13-20. doi: 10.1002/wps.20306.'}, {'pmid': '22974494', 'type': 'BACKGROUND', 'citation': 'Ellett L. Mindfulness for paranoid beliefs: evidence from two case studies. Behav Cogn Psychother. 2013 Mar;41(2):238-42. doi: 10.1017/S1352465812000586. Epub 2012 Sep 14.'}, {'pmid': '27993338', 'type': 'BACKGROUND', 'citation': 'Hayes SC. Acceptance and Commitment Therapy, Relational Frame Theory, and the Third Wave of Behavioral and Cognitive Therapies - Republished Article. Behav Ther. 2016 Nov;47(6):869-885. doi: 10.1016/j.beth.2016.11.006. Epub 2016 Nov 10.'}, {'pmid': '11556941', 'type': 'BACKGROUND', 'citation': 'Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.'}, {'pmid': '23954146', 'type': 'BACKGROUND', 'citation': 'Khoury B, Lecomte T, Gaudiano BA, Paquin K. Mindfulness interventions for psychosis: a meta-analysis. Schizophr Res. 2013 Oct;150(1):176-84. doi: 10.1016/j.schres.2013.07.055. Epub 2013 Aug 15.'}, {'pmid': '21902854', 'type': 'BACKGROUND', 'citation': 'Langer AI, Cangas AJ, Salcedo E, Fuentes B. Applying mindfulness therapy in a group of psychotic individuals: a controlled study. Behav Cogn Psychother. 2012 Jan;40(1):105-9. doi: 10.1017/S1352465811000464. Epub 2011 Sep 9.'}, {'pmid': '12547384', 'type': 'BACKGROUND', 'citation': 'Morrison AP, Wells A. A comparison of metacognitions in patients with hallucinations, delusions, panic disorder, and non-patient controls. Behav Res Ther. 2003 Feb;41(2):251-6. doi: 10.1016/s0005-7967(02)00095-5.'}, {'pmid': '24107762', 'type': 'BACKGROUND', 'citation': 'Mundt JC, Greist JH, Jefferson JW, Federico M, Mann JJ, Posner K. Prediction of suicidal behavior in clinical research by lifetime suicidal ideation and behavior ascertained by the electronic Columbia-Suicide Severity Rating Scale. J Clin Psychiatry. 2013 Sep;74(9):887-93. doi: 10.4088/JCP.13m08398.'}, {'pmid': '22193671', 'type': 'BACKGROUND', 'citation': 'Posner K, Brown GK, Stanley B, Brent DA, Yershova KV, Oquendo MA, Currier GW, Melvin GA, Greenhill L, Shen S, Mann JJ. The Columbia-Suicide Severity Rating Scale: initial validity and internal consistency findings from three multisite studies with adolescents and adults. Am J Psychiatry. 2011 Dec;168(12):1266-77. doi: 10.1176/appi.ajp.2011.10111704.'}, {'pmid': '26683229', 'type': 'BACKGROUND', 'citation': 'Ratcliffe M, Wilkinson S. How anxiety induces verbal hallucinations. Conscious Cogn. 2016 Jan;39:48-58. doi: 10.1016/j.concog.2015.11.009. Epub 2015 Dec 9.'}, {'pmid': '16717171', 'type': 'BACKGROUND', 'citation': 'Spitzer RL, Kroenke K, Williams JB, Lowe B. A brief measure for assessing generalized anxiety disorder: the GAD-7. Arch Intern Med. 2006 May 22;166(10):1092-7. doi: 10.1001/archinte.166.10.1092.'}, {'pmid': '25892974', 'type': 'BACKGROUND', 'citation': 'Terrill AL, Hartoonian N, Beier M, Salem R, Alschuler K. The 7-item generalized anxiety disorder scale as a tool for measuring generalized anxiety in multiple sclerosis. Int J MS Care. 2015 Mar-Apr;17(2):49-56. doi: 10.7224/1537-2073.2014-008.'}, {'pmid': '9403906', 'type': 'RESULT', 'citation': 'Birchwood M, Chadwick P. The omnipotence of voices: testing the validity of a cognitive model. Psychol Med. 1997 Nov;27(6):1345-53. doi: 10.1017/s0033291797005552.'}, {'pmid': '12362963', 'type': 'RESULT', 'citation': 'Bach P, Hayes SC. The use of acceptance and commitment therapy to prevent the rehospitalization of psychotic patients: a randomized controlled trial. J Consult Clin Psychol. 2002 Oct;70(5):1129-39. doi: 10.1037//0022-006x.70.5.1129.'}, {'pmid': '18310597', 'type': 'RESULT', 'citation': 'Baer RA, Smith GT, Lykins E, Button D, Krietemeyer J, Sauer S, Walsh E, Duggan D, Williams JM. Construct validity of the five facet mindfulness questionnaire in meditating and nonmeditating samples. Assessment. 2008 Sep;15(3):329-42. doi: 10.1177/1073191107313003. Epub 2008 Feb 29.'}]}, 'descriptionModule': {'briefSummary': 'The objective of this non-randomized, within-group comparison was to evaluate the addition of mindfulness as a new technique in an outpatient group therapy program for participants diagnosed with a psychotic spectrum disorder, alongside of cognitive behavioral therapy.', 'detailedDescription': 'Participants completed the Patient Health Questionnaire-9 (PHQ-9), and the Generalized Anxiety Disorder 7-item scale (GAD-7), at admission and discharge. The first experiment compared scores of those who received mindfulness training plus standard psychiatric treatment or treatment as usual (TAU) against those who received TAU. The second experiment compared age using matched scores from participants who received mindfulness training plus TAU. Participants attended group therapy for a five-week minimum, and were taught the mindfulness practices of breath, acceptance, observation, remaining non-judgmental, and letting go.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': '. Eligible participants had a\n\nDSM-5 diagnosis which included: 295.2 Schizophrenia, Catatonia type, 295.3 Schizophrenia, Paranoid Type, 295.4 Schizophreniform Disorder, 295.70 Schizoaffective Disorder, Depressed Type or Bipolar Type, 295.9 Schizophrenia, Unspecified, 296.34 Major Depressive Disorder, With Psychotic Features, 296.54 Bipolar Disorder, With Psychotic Features, 297.1 Delusional Disorder, 298.8 Brief Psychotic Disorder, 298.9 Unspecified Schizophrenia and Other Psychotic Disorders, 301.22 Schizotypal Personality Disorder.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All Diagnostic Statistical Manual, Fifth edition, (DSM-5) diagnoses that included a psychosis spectrum disorder\n\nExclusion Criteria:\n\n* those lacking symptoms of psychosis'}, 'identificationModule': {'nctId': 'NCT04711460', 'briefTitle': 'Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression', 'organization': {'class': 'OTHER', 'fullName': 'University of Minnesota'}, 'officialTitle': 'Mindfulness, Group Therapy and Psychosis; Training Decreases Anxiety and Depression in Outpatients With a Psychotic Disorder in a Non-Randomized Within Group Comparison', 'orgStudyIdInfo': {'id': 'STUDY00005035'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Younger participants', 'description': 'Participants were adults ages19 to 29 years who recieved CBT and 10 minutes of Mindfulness Training and practice in group therapy.', 'interventionNames': ['Behavioral: Younger participants']}, {'label': 'Older participants', 'description': 'Participants were adults ages 30-54 years who received CBT and 10 minutes of Mindfulness Training and practice in group therapy.', 'interventionNames': ['Behavioral: Older participants']}, {'label': 'Treatment As Usual (TAU)', 'description': '. Participants in the "Treatment As Usual" (TAU) group had Cognitive Behavioral Therapy and education about the mindfulness process, but no practice of the mindfulness technique as a group.', 'interventionNames': ['Behavioral: TAU']}, {'label': 'TAU plus mindfulness practice', 'description': 'Participants in the TAU plus Mindfulness Practice had Cognitive Behavioral Therapy (CBT) and 10 minutes of mindfulness practice in group therapy sessions.', 'interventionNames': ['Behavioral: TAU + MIndfulness practice']}], 'interventions': [{'name': 'Younger participants', 'type': 'BEHAVIORAL', 'description': 'Younger Participants 19-29 years received TAU + Tx over 5 weeks', 'armGroupLabels': ['Younger participants']}, {'name': 'Older participants', 'type': 'BEHAVIORAL', 'description': 'older participants 30-54 years received TAU + Tx over 5 weeks', 'armGroupLabels': ['Older participants']}, {'name': 'TAU', 'type': 'BEHAVIORAL', 'description': 'Participants received TAU or Treatment As Ususal, Cognitive Behavior Therapy only', 'armGroupLabels': ['Treatment As Usual (TAU)']}, {'name': 'TAU + MIndfulness practice', 'type': 'BEHAVIORAL', 'description': 'Participants received TAU + mindfulness training', 'armGroupLabels': ['TAU plus mindfulness practice']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Joan D Lund, Psy.D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Minnesota'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data is not available for sharing'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Minnesota', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}