Ignite Creation Date:
2025-12-25 @ 2:50 AM
Ignite Modification Date:
2026-01-09 @ 8:16 AM
Study NCT ID:
NCT03043833
Status:
COMPLETED
Last Update Posted:
2018-05-01
First Post:
2017-01-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003865', 'term': 'Depressive Disorder, Major'}, {'id': 'D001008', 'term': 'Anxiety Disorders'}], '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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 64}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-01-18', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-04', 'completionDateStruct': {'date': '2018-03-30', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-04-30', 'studyFirstSubmitDate': '2017-01-30', 'studyFirstSubmitQcDate': '2017-02-02', 'lastUpdatePostDateStruct': {'date': '2018-05-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-02-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-01-30', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in depression as assessed by the Patient Health Questionnaire-9 (PHQ-9)', 'timeFrame': 'Pretest, posttest (week 8), 3-month follow-up', 'description': 'Symptoms of depression'}, {'measure': 'Changes in anxiety as assessed by the Generalized Anxiety Disorder-7 (GAD-7)', 'timeFrame': 'Pretest, posttest (week 8), 3-month follow-up', 'description': 'Symptoms of anxiety'}], 'secondaryOutcomes': [{'measure': 'Changes in life satisfaction as assessed by the Satisfaction with Life Scale (SWLS)', 'timeFrame': 'Pretest, posttest (week 8), 3-month follow-up', 'description': 'Life satisfaction as assessed by the SWLS (Diener et al.,1995)'}, {'measure': 'Changes in health as assessed by the Short-Form Health Survey', 'timeFrame': 'Pretest (week 1), posttest (week 8), 3-month follow-up', 'description': 'Physical and mental health as assessed by the Short-Form Health Survey (SF-12; Ware et al., 1998)'}, {'measure': 'Changes in personality as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale', 'timeFrame': 'Pretest (week 1), posttest (week 8), 3-month follow-up', 'description': 'Pathological personality traits as assessed by the Self-administered Standardised Assessment of Personality - Abbreviated Scale (SAPAS)'}, {'measure': 'Changes in anxiety as assessed by the Penn State Worry Questionnaire (PSWQ)', 'timeFrame': 'Pretest (week 1), posttest (week 8), 3-month follow-up', 'description': 'Symptoms of worry'}, {'measure': 'Changes in social anxiety as assessed by the Social Phobia Inventory (SPIN)', 'timeFrame': 'Pretest (week 1), posttest (week 8), 3-month follow-up', 'description': 'Symptoms of social anxiety symptoms'}, {'measure': 'Changes in panic and agoraphobia as assessed by the Panic and Agoraphobia Scale (PAS)', 'timeFrame': 'Pretest (week 1), posttest (week 8), 3-month follow-up', 'description': 'frequency and intensity of panic symptoms'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Major Depression', 'Anxiety Disorders']}, 'descriptionModule': {'briefSummary': "This study represents Phase II of a research program involving an international collaboration with Macquarie University (Sydney, Australia) to implement an Internet-based cognitive behavior therapy for the treatment of anxiety and depression in French-speaking Canadians from the Atlantic Provinces.\n\nThe primary objective is to establish the clinical efficacy of a French-Canadian self-guided format version of the Wellbeing Course by conducting a randomized-control trial where an experimental group will be compared to a waitlist control group. A secondary objective is to demonstrate the course's acceptability through participants' satisfaction with the course."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Residing in New-Brunswick, Nova-Scotia, Prince Edward Island, or Newfound land \\& Labrador\n* Having identified French as the first official language spoken and having good reading comprehension in French.\n* Reliable Internet access\n* Clinically significant levels of depression or anxiety reflected by significant scores on the following measures: PHQ-9 \\> 9, GAD-7 \\>7, Penn Stage Worry Questionnaire ≥ 45, Social Phobia Inventory ≥ 19, Panic and Agoraphobia Scale ≥ 19, or by answering yes to the question "Is anxiety or low mood a problem for you"\n* Not currently participating in cognitive-behavioral therapy\n* No changes in medication for 4 weeks prior to the study, nor any changes in medication for the next 2 months\n* Willing to disclose personal information\n\nExclusion Criteria:\n\n* Presence of psychotic symptoms\n* Presence of severe depression as indicated by scores ≥ 23 on the PHQ-9, or a score \\> 2 on item 9 of the PHQ-9'}, 'identificationModule': {'nctId': 'NCT03043833', 'briefTitle': 'Internet-Delivered Cognitive Behavior Therapy for Anxiety and Depression Amongst French Canadians', 'organization': {'class': 'OTHER', 'fullName': 'Universite de Moncton'}, 'officialTitle': 'Improving Access to Treatment for Anxiety and Depression Among French Canadians Using an Internet-Delivered Cognitive Behavior Therapy: A Randomized Controlled Trial', 'orgStudyIdInfo': {'id': 'File 1516-077'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Wellbeing Course', 'description': 'Will receive the French-Canadian version of the Wellbeing Course consisting of five lessons based on cognitive behavior therapy delivered through the Internet over eight weeks.', 'interventionNames': ['Behavioral: The Wellbeing Course']}, {'type': 'NO_INTERVENTION', 'label': 'Waitlist-control', 'description': 'The Waitlist Control Group will receive the French-Canadian version of the Wellbeing Course once the treatment group will have completed treatment.'}], 'interventions': [{'name': 'The Wellbeing Course', 'type': 'BEHAVIORAL', 'description': 'The Wellbeing Course (Titov et al., 2011) includes five online lessons:\n\n* Lesson 1 presents information on the prevalence of anxiety disorders and depression as well as on how they may interfere with life goals. This lesson also discusses how cognitive, behavioral and physical symptoms can contribute to poor emotional health.\n* Lesson 2 presents different strategies to generate realistic cognitions.\n* Lesson 3 describes strategies for physical de-arousal and for re-engaging in reinforcing activities.\n* Lesson 4 describes avoidance and safety behaviors in relation with anxiety and depression along with graded exposure.\n* Lesson 5 is about problem solving, relapse prevention and staying well.\n\nFor each lesson, a "Do It Yourself" guide is included as well vignettes and additional material.', 'armGroupLabels': ['Wellbeing Course']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'E1A 3E9', 'city': 'Moncton', 'state': 'New Brunswick', 'country': 'Canada', 'facility': 'Université de Moncton - Adult Clinical Psychology Laboratory', 'geoPoint': {'lat': 46.09454, 'lon': -64.7965}}], 'overallOfficials': [{'name': 'France Talbot, Ph.D.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Université de Moncton'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED', 'description': 'There is currently in place a memorandum of understanding with Macquarie University, our collaborators. This agreement allows for the sharing of data once personally identifiable information has been removed.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universite de Moncton', 'class': 'OTHER'}, 'collaborators': [{'name': 'Macquarie University, Australia', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'France Talbot', 'investigatorAffiliation': 'Universite de Moncton'}}}}