Ignite Creation Date:
2025-12-24 @ 11:33 PM
Ignite Modification Date:
2026-02-20 @ 6:40 PM
Study NCT ID:
NCT02091856
Status:
TERMINATED
Last Update Posted:
2018-06-28
First Post:
2014-03-05
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Internet-delivered Psychotherapy for Depression
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015928', 'term': 'Cognitive Behavioral Therapy'}], 'ancestors': [{'id': 'D001521', 'term': 'Behavior Therapy'}, {'id': 'D011613', 'term': 'Psychotherapy'}, {'id': 'D004191', 'term': 'Behavioral Disciplines and Activities'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'btulbure@gmail.com', 'phone': '+040745753061', 'title': 'Dr. Bogdan Tudor Tulbure', 'organization': 'West University of Timisoara'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}, 'limitationsAndCaveats': {'description': '1\\) A high drop out rate at post-test \\& follow-up. 2) The outcome assessments were not fully blind. 3) Participants in C-CBT \\& R-CBT were self-selected based on their religiousness.'}}, 'adverseEventsModule': {'timeFrame': 'Other Adverse Events (depression levels) were collected weekly through study completion (an average of 11 weeks).', 'description': 'Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that major depression or dysthymia represents Other Adverse Events that occurred in all participants.', 'eventGroups': [{'id': 'EG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.', 'otherNumAtRisk': 34, 'otherNumAffected': 34, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.', 'otherNumAtRisk': 19, 'otherNumAffected': 19, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}, {'id': 'EG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.', 'otherNumAtRisk': 26, 'otherNumAffected': 26, 'seriousNumAtRisk': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Major depression disorder (MDD) or dysthymia', 'notes': 'Because assessment data were collected online Serious Adverse Events were not assessed as part of the study. Considering the inclusion criteria PI inferred that MDD or dysthimia represents Other Adverse Events that occurred in all participants', 'stats': [{'groupId': 'EG000', 'numAtRisk': 34, 'numEvents': 34, 'numAffected': 34}, {'groupId': 'EG001', 'numAtRisk': 19, 'numEvents': 19, 'numAffected': 19}, {'groupId': 'EG002', 'numAtRisk': 26, 'numEvents': 26, 'numAffected': 26}], 'organSystem': 'Psychiatric disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Beck Depression Inventory-II (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.'}, {'id': 'OG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'OG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}], 'classes': [{'categories': [{'measurements': [{'value': '11.45', 'spread': '10.46', 'groupId': 'OG000'}, {'value': '12.43', 'spread': '15.04', 'groupId': 'OG001'}, {'value': '26.02', 'spread': '8.74', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'pValueComment': 'The a priori threshold for statistical significance was set at .05', 'groupDescription': 'It was hypothesized that regardless of the CBT version received (conventional or religious), those in the active treatments would achieve a greater reduction in depressive and associated symptoms than participants in the wait-list condition.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Changes in primary outcome measures were evaluated using repeated measures ANOVA for three groups: C-CBT, R-CBT, WLCG and two time points: pre \\& post'}], 'paramType': 'MEAN', 'timeFrame': 'Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)', 'description': "The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.\n\nThis represents the post-intervention assessment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Beck Anxiety Inventory (BAI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.'}, {'id': 'OG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'OG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}], 'classes': [{'categories': [{'measurements': [{'value': '24.72', 'spread': '13.60', 'groupId': 'OG000'}, {'value': '22.62', 'spread': '13.90', 'groupId': 'OG001'}, {'value': '27.27', 'spread': '12.33', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '>0.05', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The a priori threshold for statistical significance was set at .05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Changes in secondary outcome measures were evaluated using repeated measures ANOVA (C-CBT, R-CBT, WLCG at pre- and post-intervention).'}], 'paramType': 'MEAN', 'timeFrame': 'Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)', 'description': "The Beck Anxiety Inventory (BAI) was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.\n\nThis represent the post-intervention assessment.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quality of Life Inventory (QOLI)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.'}, {'id': 'OG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'OG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}], 'classes': [{'categories': [{'measurements': [{'value': '.74', 'spread': '2.03', 'groupId': 'OG000'}, {'value': '.39', 'spread': '1.62', 'groupId': 'OG001'}, {'value': '-.92', 'spread': '1.79', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The a priori threshold for statistical significance was set at .05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Absolute values (average score) of QOLI at 11 weeks (post-intervention)', 'description': 'The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality.\n\nThis represents the post-intervention assessment.', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}, {'value': '26', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.'}, {'id': 'OG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'OG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}], 'classes': [{'categories': [{'measurements': [{'value': '10.47', 'spread': '5.69', 'groupId': 'OG000'}, {'value': '10.27', 'spread': '6.17', 'groupId': 'OG001'}, {'value': '14.90', 'spread': '4.24', 'groupId': 'OG002'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000', 'OG001', 'OG002'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The a priori threshold for statistical significance was set at .05', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)', 'description': "The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.\n\nThis represents a secondary outcome measure for depression taken immediately after the intervention.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Beck Depression Inventory II (BDI-II)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '10', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}, {'value': '0', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.'}, {'id': 'OG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'OG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}], 'classes': [{'categories': [{'measurements': [{'value': '15.20', 'spread': '13.11', 'groupId': 'OG000'}, {'value': '13.56', 'spread': '12.49', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.01', 'groupIds': ['OG000', 'OG001'], 'ciNumSides': 'TWO_SIDED', 'pValueComment': 'The a priori threshold for statistical significance was set at .05', 'statisticalMethod': 't-test, 1 sided', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Absolute values (average score) of BDI-II at 37 weeks (follow-up)', 'description': "The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.\n\nThis represents the measure of depression at 6 month after the intervention.", 'unitOfMeasure': 'units on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only 10 participants from the C-CBT and 9 participants from the R-CBT completed the follow-up assessment questionnaires. Participants from the Wailt-List Control Group were lost at follow-up.'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Conventional CBT intervention includes set of exercises devised from the mindfulness paradigm.'}, {'id': 'FG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'FG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}], 'periods': [{'title': 'Active Intervention Interval', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '34'}, {'groupId': 'FG001', 'numSubjects': '19'}, {'groupId': 'FG002', 'numSubjects': '26'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '15'}, {'groupId': 'FG001', 'numSubjects': '12'}, {'groupId': 'FG002', 'numSubjects': '19'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '19'}, {'groupId': 'FG001', 'numSubjects': '7'}, {'groupId': 'FG002', 'numSubjects': '7'}]}]}, {'title': 'Follow-up Assessment', 'milestones': [{'type': 'STARTED', 'achievements': [{'comment': 'Only a subset of C-CBT participants responded to our request to complete the follow-up assessment.', 'groupId': 'FG000', 'numSubjects': '15'}, {'comment': 'Only a subset of R-CBT participants responded to our request to complete the follow-up assessment.', 'groupId': 'FG001', 'numSubjects': '12'}, {'comment': 'WLCG participants were lost at follow-up.', 'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '10'}, {'groupId': 'FG001', 'numSubjects': '9'}, {'groupId': 'FG002', 'numSubjects': '0'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '5'}, {'groupId': 'FG001', 'numSubjects': '3'}, {'groupId': 'FG002', 'numSubjects': '0'}]}]}]}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}], 'groups': [{'id': 'BG000', 'title': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'BG001', 'title': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.\n\nCognitive Behavioral Therapy (CBT): Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.'}, {'id': 'BG002', 'title': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}, {'id': 'BG003', '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'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}, {'value': '0', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '29.21', 'spread': '8.88', 'groupId': 'BG000'}, {'value': '32.21', 'spread': '11.66', 'groupId': 'BG001'}, {'value': '35.65', 'spread': '9.15', 'groupId': 'BG002'}, {'value': '32.05', 'spread': '9.97', 'groupId': 'BG003'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '30', 'groupId': 'BG000'}, {'value': '16', 'groupId': 'BG001'}, {'value': '19', 'groupId': 'BG002'}, {'value': '65', 'groupId': 'BG003'}]}, {'title': 'Male', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}, {'value': '14', 'groupId': 'BG003'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Romania', 'categories': [{'measurements': [{'value': '34', 'groupId': 'BG000'}, {'value': '19', 'groupId': 'BG001'}, {'value': '26', 'groupId': 'BG002'}, {'value': '79', 'groupId': 'BG003'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 79}}, 'statusModule': {'whyStopped': 'We have recruited and treated 79 participants', 'overallStatus': 'TERMINATED', 'startDateStruct': {'date': '2014-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-02', 'completionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-19', 'studyFirstSubmitDate': '2014-03-05', 'resultsFirstSubmitDate': '2015-11-20', 'studyFirstSubmitQcDate': '2014-03-17', 'lastUpdatePostDateStruct': {'date': '2018-06-28', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2016-02-25', 'studyFirstPostDateStruct': {'date': '2014-03-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2016-03-28', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Beck Depression Inventory-II (BDI-II)', 'timeFrame': 'Absolute values (average score) of Back Depression Inventory-II at 11 weeks (post-intervention)', 'description': "The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.\n\nThis represents the post-intervention assessment."}, {'measure': 'Beck Depression Inventory II (BDI-II)', 'timeFrame': 'Absolute values (average score) of BDI-II at 37 weeks (follow-up)', 'description': "The Beck Depression Inventory-II (BDI-II) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.\n\nThis represents the measure of depression at 6 month after the intervention."}], 'secondaryOutcomes': [{'measure': 'Beck Anxiety Inventory (BAI)', 'timeFrame': 'Absolute values (average score) of Back Anxiety Inventory at 11 weeks (post-intervention)', 'description': "The Beck Anxiety Inventory (BAI) was designed to measure participant's level of anxiety. The scale is unidimensional and the total score rages from 0 to 63. Low scores are associated with low levels of anxiety, while high scores are associated with high levels of anxiety.\n\nThis represent the post-intervention assessment."}, {'measure': 'Quality of Life Inventory (QOLI)', 'timeFrame': 'Absolute values (average score) of QOLI at 11 weeks (post-intervention)', 'description': 'The Quality of Life Inventory (QOLI) is an established rating scale of self-perceived quality of life across 16 domains. The scale is unidimensional and the total score rages from -6 to +6. Low scores are associated with low self-perceived life quality, while high scores are associated with high self-perceived life quality.\n\nThis represents the post-intervention assessment.'}, {'measure': 'Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR)', 'timeFrame': 'Absolute values (average score) of QIDS-SR after 11 weeks (post-treatment)', 'description': "The Quick Inventory of Depressive Symptomatology - Self Report (QIDS-SR) was designed to measure participant's level of depression. The scale is unidimensional and the total score rages from 0 to 27. Low scores are associated with low levels of depression, while high scores are associated with high levels of depression.\n\nThis represents a secondary outcome measure for depression taken immediately after the intervention."}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Mild - Major Depression']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.iterapi.se/sites/psitod', 'label': 'Public pages describing the PsiTOD project (in Romanian)'}]}, 'descriptionModule': {'briefSummary': 'Project aim: To compare the effectiveness and acceptability of a conventional and a religious internet-supported cognitive behavior therapy (iCBT) for depression in Romania.', 'detailedDescription': 'Previous studies suggest that incorporating religious beliefs into conventional CBT appears to be helpful for religious individuals. In order to have two active comparable interventions the investigators added to the conventional CBT a similar set of exercises devised from the positive psychology paradigm.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* be fluent in Romanian\n* be over 18 years\n* have a diagnosis of current major depression disorder\n* have access to an Internet connected computer\n\nExclusion Criteria:\n\n* suicidal ideation\n* ongoing psychological treatment for depression\n* other primary disorder that need treatment\n* obstacle to participation (i.e., long travel plans)\n* recent change in psychiatric medication (i.e., during the last 6 weeks)'}, 'identificationModule': {'nctId': 'NCT02091856', 'acronym': 'PsiTOD', 'briefTitle': 'Internet-delivered Psychotherapy for Depression', 'organization': {'class': 'OTHER', 'fullName': 'West University of Timisoara'}, 'officialTitle': 'Internet-delivered Cognitive-Behavioral Therapy for Depression: A Randomized Controlled Trial (PsiTOD)', 'orgStudyIdInfo': {'id': 'WUTimisoara-PsiTOD'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Conventional-CBT (C-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the mindfulness paradigm.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)']}, {'type': 'EXPERIMENTAL', 'label': 'Religious CBT (R-CBT)', 'description': 'This arm represents the classical Cognitive Behavioral Therapy (CBT) approach for major depression disorder (MDD) plus a set of exercises devised from the general Christian belief.', 'interventionNames': ['Behavioral: Cognitive Behavioral Therapy (CBT)']}, {'type': 'NO_INTERVENTION', 'label': 'Wait List Control Group (WLCG)', 'description': 'This arm represents the wait-list comparison group.'}], 'interventions': [{'name': 'Cognitive Behavioral Therapy (CBT)', 'type': 'BEHAVIORAL', 'description': 'Cognitive behavioral therapy (CBT) represents a psychotherapeutic approach that helps patients understand the thoughts and feelings that influence behaviors. The underlying concept behind CBT is that thoughts and feelings play a fundamental role in behavior. Beyond the conventional CBT techniques proven effective for MDD, the Positive CBT intervention includes set of exercises devised from the positive psychology paradigm. Similarly, the Christian CBT intervention includes a comparable set of exercises rooted on the general Christian belief.', 'armGroupLabels': ['Conventional-CBT (C-CBT)', 'Religious CBT (R-CBT)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '300223', 'city': 'Timișoara', 'state': 'Timiș County', 'country': 'Romania', 'facility': 'West University of Timisoara', 'geoPoint': {'lat': 45.75372, 'lon': 21.22571}}], 'overallOfficials': [{'name': 'Bogdan Tudor Tulbure, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'West University of Timisoara'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'West University of Timisoara', 'class': 'OTHER'}, 'collaborators': [{'name': 'Linkoeping University', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}