Ignite Creation Date:
2025-12-24 @ 3:18 PM
Ignite Modification Date:
2026-02-24 @ 6:44 AM
Study NCT ID:
NCT03304392
Status:
COMPLETED
Last Update Posted:
2020-02-20
First Post:
2017-09-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Therapist-guided Internet-delivered Cognitive Behavioural Therapy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}, {'id': 'D003863', 'term': 'Depression'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}, {'id': 'D001526', 'term': 'Behavioral Symptoms'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 449}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-10-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-11', 'completionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-02-18', 'studyFirstSubmitDate': '2017-09-29', 'studyFirstSubmitQcDate': '2017-10-05', 'lastUpdatePostDateStruct': {'date': '2020-02-20', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-10-09', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-10-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in depression', 'timeFrame': 'baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by Patient Health Questionnaire - 9 Item (PHQ-9)'}, {'measure': 'Change in anxiety', 'timeFrame': 'baseline, start of each Lesson 2-5, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by Generalize Anxiety Disorder - 7 Item (GAD7)'}], 'secondaryOutcomes': [{'measure': 'Change in psychological distress', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by Kessler 10-Item Scale'}, {'measure': 'Change in disability', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measure by Sheehan Disability Scale-3 Item'}, {'measure': 'Change in panic symptoms', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by Panic Disorder Severity Scale-Self Report'}, {'measure': 'Change in social anxiety symptoms', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by Social Interaction Anxiety Scale'}, {'measure': 'Change in social phobia symptoms', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by Social Phobia Scale-Short form'}, {'measure': 'Change in post-traumatic symptoms', 'timeFrame': 'Administered to only those participants meeting criteria for post-traumatic stress based on the modified brief Life Events Checklist for DSM 5 (LEC-5) at each time point: baseline, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by PTSD Checklist 5'}, {'measure': 'Change in quality of life symptoms', 'timeFrame': 'baseline, 8 weeks, 3 months, 6 months, and 1 year follow up', 'description': 'Measured by EQ-5D-5L'}, {'measure': 'Change in treatment costs', 'timeFrame': 'Part 1 and 2: baseline, 3 months, 6 months, and 1 year follow up; Part 3: baseline and 1 year follow up', 'description': 'Measured by Treatment Inventory of Costs in Psychiatric Patients (TIC-P) Adapted for Canada'}, {'measure': 'Therapeutic alliance', 'timeFrame': '8 weeks', 'description': 'Measured by Working Alliance Inventory-Short Form'}, {'measure': 'Treatment credibility', 'timeFrame': 'baseline and 8 weeks', 'description': 'Measured by Credibility Questionnaire'}, {'measure': 'Treatment satisfaction', 'timeFrame': '8 weeks', 'description': 'Measured by Internet-CBT Treatment Satisfaction Measure'}, {'measure': 'Engagement', 'timeFrame': '8 weeks', 'description': 'Measured by: number of lessons completed, number of days of access, number of emails sent to therapist, number of phone calls with therapist, number of emails from therapist to client, total words emailed to therapist, total words emailed from therapist to patient'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['anxiety', 'depression', 'internet-delivered cognitive behaviour therapy', 'randomized controlled trial', 'patient-centered', 'knowledge implementation', 'mental health system', 'therapist-assistance'], 'conditions': ['Anxiety', 'Depression']}, 'descriptionModule': {'briefSummary': 'Depression and anxiety are prevalent and disabling conditions that often go untreated. Internet-delivered Cognitive Behaviour Therapy (ICBT) is a relatively new approach to treatment that is a convenient way for patients to access care. ICBT is typically highly standardized and involves patients reviewing weekly lessons over the Internet. Patients also receive brief weekly support from a therapist via secure emails or phone calls. Past research shows that \\~75% of patients complete ICBT and report large symptom improvements. Although these results are very promising, research also suggests that ICBT could potentially be improved by being more personalized in terms of amount of therapist contact, especially for clients with more severe symptoms. The current trial will involve therapists who work in a clinic that specializes in ICBT. Over one year, 440 patients with depression and/or anxiety will be randomized to either receive standardized (5 lessons completed in 8 weeks; once week therapist contact) or personalized ICBT (5 lessons completed in 8 weeks; personalized therapist contact depending on needs of patient). Psychosocial outcomes of patients in the two treatment arms will be compared post-treatment and at 3-month, 6-month, and 1-year follow-up from enrollment. Data on intervention usage, satisfaction measures, and costs will also be assessed.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* 18 years of age or older\n* residing in Saskatchewan, Canada\n* endorsing symptoms of anxiety or depression\n* able to access a computer and internet service\n* willing to provide a physician as emergency contact\n\nExclusion Criteria:\n\n* high suicide risk\n* suicide attempt or hospitalization in the last year\n* primary problems with psychosis, alcohol or drug problems, mania\n* currently receiving active psychological treatment for anxiety or depression\n* not present in province during treatment; concerns about online therapy'}, 'identificationModule': {'nctId': 'NCT03304392', 'briefTitle': 'Therapist-guided Internet-delivered Cognitive Behavioural Therapy', 'organization': {'class': 'OTHER', 'fullName': 'University of Regina'}, 'officialTitle': 'Advancing Mental Health Care by Improving the Delivery of Therapist-guided, Internet-delivered Cognitive Behavioural Therapy in Clinical Practice', 'orgStudyIdInfo': {'id': '375860'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Personalized ICBT', 'description': "An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.", 'interventionNames': ['Behavioral: Personalized ICBT']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Standard ICBT', 'description': 'An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.', 'interventionNames': ['Behavioral: Standard ICBT']}], 'interventions': [{'name': 'Personalized ICBT', 'type': 'BEHAVIORAL', 'description': "An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support within one business day of client emails. Amount of contact will be personalized to patients' needs.", 'armGroupLabels': ['Personalized ICBT']}, {'name': 'Standard ICBT', 'type': 'BEHAVIORAL', 'description': 'An 8-week transdiagnostic internet-delivered cognitive behavioural therapy (ICBT) will be delivered to participants. All clients will receive support from registered social workers, psychologists or supervised graduate students, with experience delivering ICBT, with contact depending upon group allocation. In addition to the online program, therapists, registered social workers, psychologists or supervised graduate students, with experience delivering ICBT will provide support by email only once a week. Therapist will spend approximately 15 minutes per week/per client.', 'armGroupLabels': ['Standard ICBT']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S4S 0A2', 'city': 'Regina', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'Online Therapy Unit, University of Regina', 'geoPoint': {'lat': 50.45008, 'lon': -104.6178}}], 'overallOfficials': [{'name': 'Heather D Hadjistavropoulos, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Regina'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Regina', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'SPONSOR'}}}}