Ignite Creation Date:
2025-12-24 @ 10:04 PM
Ignite Modification Date:
2026-01-02 @ 9:03 AM
Study NCT ID:
NCT04825535
Status:
SUSPENDED
Last Update Posted:
2024-04-08
First Post:
2021-03-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}], 'ancestors': [{'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR'], 'maskingDescription': 'One assessor will be blinded to the (2) comparison groups of all participants.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Online CBT intervention'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 156}}, 'statusModule': {'whyStopped': 'Study suspended due to issues flagged during an internal Quality Assurance audit.', 'overallStatus': 'SUSPENDED', 'startDateStruct': {'date': '2024-04', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-04', 'studyFirstSubmitDate': '2021-03-21', 'studyFirstSubmitQcDate': '2021-03-30', 'lastUpdatePostDateStruct': {'date': '2024-04-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-04-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-04', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Beck Depression Inventory - 2 (0 to 63 - higher score indicates worse outcome)', 'timeFrame': 'Baseline and 4 months', 'description': 'Frequently used and validated self report measure'}], 'secondaryOutcomes': [{'measure': 'Change in Beck Anxiety Inventory (0 to 63 - higher score indicates worse outcome)', 'timeFrame': 'Baseline and 4 months', 'description': 'Frequently used and validated self report measure'}, {'measure': 'Change in Quick Inventory of Depressive Symptoms (0 to 48 - higher score indicates worse outcome)', 'timeFrame': 'Baseline and 4 months', 'description': 'Frequently used and validated self report measure'}, {'measure': 'Change in Hamilton Depression Rating Scale - 24-item version (0 to 72) Hamilton Depression Rating Scale - 24 item (0 - 96 - higher score indicates worse outcome)', 'timeFrame': 'Baseline and 4 months', 'description': 'Frequently used and validated interview-based evaluation instrument'}, {'measure': 'Change in 5-Facet Mindfulness Questionnaire - 39-item version (39 to 195 - higher score indicates better outcome) Five-Facet Mindfulness Questionnaire', 'timeFrame': 'Baseline and 4 months', 'description': 'Frequently used and validated self report measure'}, {'measure': 'Change in Brief Pain Inventory - 11 item (0 - 176 - high score indicates worse outcome)', 'timeFrame': 'Baseline and 4 months', 'description': 'Frequently used and validated self report measure'}, {'measure': 'Change in EuroQol-5 Dimension (EQ-5D) Quality of Life Instrument - 5 items - 0 - 25 - high score - worse outcome)', 'timeFrame': 'Baseline and 4 months', 'description': 'Frequently used and validated self report measure'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['internet-based intervention', 'major depressive disorder', 'health coaching'], 'conditions': ['Major Depressive Disorder']}, 'referencesModule': {'references': [{'pmid': '35393942', 'type': 'DERIVED', 'citation': 'Ritvo P, Gratzer D, Knyahnytska Y, Ortiz A, Walters C, Katz J, Laposa J, Baldissera C, Wayne N, Pfefer-Litman D, Tomlinson G, Daskalakis Z. Comparing Online and On-Site Cognitive Behavior Therapy in Major Depressive Disorder: Protocol for a Noninferiority Randomized Controlled Trial. JMIR Res Protoc. 2022 Apr 8;11(4):e29726. doi: 10.2196/29726.'}]}, 'descriptionModule': {'briefSummary': 'In recent years, Cognitive Behavioral Therapy has been integrated with mindfulness meditation (CBT-M) following evidence for increased efficacy when modalities are combined. We will assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults with major depressive disorder (MDD). This non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.', 'detailedDescription': 'Depression is a commonly diagnosed mental health disorder that represents the most prevalent cause of disability worldwide. Cognitive Behavioural Therapy (CBT) is the best-evidenced treatment for depression, but despite demonstrated efficacy, many individuals cannot access adequate psychotherapeutic treatment due to the limitations of face-to-face delivery. In recent years, CBT has been integrated with mindfulness meditation (CBT-M) following strong evidence for increased efficacy when the two modalities are combined. Previous RCTs have demonstrated that online CBT-M is effective in depressive symptom reduction, but direct comparisons to in-office CBT delivery assessing cost and treatment outcomes are required to facilitate innovation and clinical policy change.\n\nObjectives: To assess whether online group CBT-M plus standard psychiatric care is non-inferior in efficacy and more cost-effective than office-based, on-site group CBT-M (plus standard psychiatric care) per outcomes at post-intervention and at 6-month follow up in adults diagnosed with major depressive disorder (MDD). The study will assess whether digitally recorded adherence data (i.e. online workbooks completed, Fitbit tracked step count, online text-messages exchanged, phone sessions completed) predict outcome benefits in the online-group participants as measured by changes in depressive symptoms.\n\nMethods: This single-centre, 2-arm non-inferiority randomized controlled trial will employ both assessor-blinded and self-report outcome measures and will include a full economic evaluation.\n\nThe research site is the Centre for Addiction and Mental Health (CAMH), a large research-based psychiatry institution located in Toronto, Canada. Participants will be identified from wait-lists for CAMH services and through contacts with other Toronto outpatient clinics.\n\nInterventions: All participants will receive standard psychiatric care (1 pharmacotherapy focused visit/month with a psychiatrist of 15-30 minute duration). Experimental participants additionally receive online CBT-M while control participants receive standard care in-office group CBT-M. The online group CBT-M program (in collaboration with NexJ Health, Inc.) combines exposure to smartphone and computer accessed workbooks with phone-based mental health counselling (16 hours in 16 weeks) that coordinates with ongoing software interactions (e.g. secure text messaging, Fitbit tracked walking). Each participant is loaned a Fitbit-HR Charge 3 to assess physical activity as measured by daily step count.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Beck Depression Inventory-II of at least mild severity (BDI-II score ≥ 14) with no upper severity limit;\n* Psychiatrist diagnosis of Major Depression Disorder;\n* Mini-International Neuropsychiatric Interview (MINI)-confirmed diagnosis of Major Depression Disorder;\n* fluent in English.\n\nExclusion Criteria:\n\n* individuals currently receiving weekly structured psychotherapy;\n* individuals who meet Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for severe alcohol/substance use disorder (in the past 3 months), borderline personality disorder, schizophrenia or any other primary psychotic disorder, bipolar disorder or obsessive-compulsive disorder;\n* individuals who manifest clinically significant suicidal ideation defined as imminent intent or attempted suicide (in the past 6 months);\n* individuals who are judged to have treatment resistant depression (TRD), as defined by failure in at least two trials of antidepressant medications and/or a course of psychotherapy during the current depressive episode'}, 'identificationModule': {'nctId': 'NCT04825535', 'briefTitle': 'Non-Inferiority RCT Comparing Online and On-Site CBT in MDDi', 'organization': {'class': 'OTHER', 'fullName': 'Centre for Addiction and Mental Health'}, 'officialTitle': 'A Non-Inferiority Randomized Controlled Trial Comparing Online and On-Site Cognitive Behaviour Therapy in Major Depressive Disorder', 'orgStudyIdInfo': {'id': '08-2020'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Standard psychiatry and cognitive behavioural online intervention', 'description': 'The online group CBT-M program combines software-based workbooks with phone-based Navigator-Coaching that coordinates software interactions (e.g., secure text messaging, Fitbit tracked walking, food monitoring via photography). Navigation coaching is supplied by students who were pursuing graduate degrees (MSc, MA, PhD) in kinesiology and health science, education, and psychology.', 'interventionNames': ['Behavioral: Standard psychiatry and cognitive behavioral online intervention']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard psychiatry and cognitive behavioural in-person intervention', 'description': 'The on-site, usual-care CBT group follows the structure of the Mind Over Mood workbook in reviewing CBT concepts and procedures. A series of work sheets assist participants in differentiating moods, and in differentiating moods from thoughts and situational influences, leading to modifications of thinking, behaviour, emotion and mood. Group leaders are standard leaders in the CAMH group-CBT program who have Masters-level degrees in psychology, social work and occupational therapists.', 'interventionNames': ['Behavioral: Standard psychiatry and cognitive behavioural in-person intervention']}], 'interventions': [{'name': 'Standard psychiatry and cognitive behavioral online intervention', 'type': 'BEHAVIORAL', 'description': 'The cognitive behavioral online intervention has been assessed in a prior trial. Ritvo, P, Knyahnytska, Y, Pirboglou, M, Wang, W, Tomlinson, G, Zhao, H, Linklater, R, Kirk, M., Katz, J., Harber, L., Daskalakis, ZJ An online mindfulness-based cognitive behavioural therapy intervention for youth diagnosed with major depressive disorders: J Med Internet Res 2021, Mar 17; 23 (3), e24380', 'armGroupLabels': ['Standard psychiatry and cognitive behavioural online intervention']}, {'name': 'Standard psychiatry and cognitive behavioural in-person intervention', 'type': 'BEHAVIORAL', 'description': 'The effectiveness of standard care office-based group CBT-MM at CAMH is indicated in a past study (n = 119) where depression symptoms reduced (after 16 weeks treatment) by 27% \\[3,18 \\]. The office-based groups follow a carefully conceived structure that centers on the workbook Mind Over Mood (MOM) (Guilford Press) \\[41\\]. Key CBT concepts and procedures are conveyed via work sheets that structure personal and group exploration.', 'armGroupLabels': ['Standard psychiatry and cognitive behavioural in-person intervention']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M6J 1H4', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Centre for Addiction and Mental Health', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'David Gratzer, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Centre for Addiction and Mental Health'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'No. We may consider investigators who wish to use data in further analyses but we cannot guarantee access.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Centre for Addiction and Mental Health', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}