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Stepped Care for Depression
N/A
Waitlist Available
Led By Nazanin Alavi, MD, FRCPC
Research Sponsored by Dr. Nazanin Alavi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 3, 6, 9, 12
Awards & highlights
Study Summary
This trialoffers e-CBT for MDD over 12 weeks to help reduce symptoms. It includes modules, homework, feedback & interaction with therapists. Questionnaires & physiological data will be used to evaluate efficacy. The second arm adds a stepped care approach if needed.
Eligible Conditions
- Depression
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ week 3, 6, 9, 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 3, 6, 9, 12
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in quality of life (Quality of Life Enjoyment and Satisfaction Questionnaire)
Change in symptoms (Participant Health Questionnaire - 9 Item)
Change in symptoms (Quick Inventory of Depressive Symptoms)
Trial Design
2Treatment groups
Experimental Treatment
Group I: e-CBT + Stepped CareExperimental Treatment2 Interventions
1 - Participant will receive message from assigned care provider on OPTT who check-in with them about strategies and techniques they have discussed and remind them of weekly homework due date.
2.- Participant will receive phone call from therapist who will check-in on them, remind them of therapy strategies, and verbally remind them of weekly homework due date.
3 - Participant will receive phone call from assigned care provider who will check-in on them, remind them of some therapy strategies and techniques and weekly session due date, and provide CBT summary of previously reviewed CBT concepts.
4 - articipant will receive video call (Microsoft Teams) from their therapist who will check-in on them, remind them of weekly session due date, and provide CBT content support to participant.
5 - Participant will receive CBT sessions in live video call (Microsoft Teams) with research psychiatrist involved in care.
Group II: e-CBTExperimental Treatment1 Intervention
12 weekly sessions with approximately 30 slides and interactive content, delivered through OPTT designed to mirror in-person standard CBT. Participants go through the content and complete homework at the end of the session. Homework is submitted through OPTT and reviewed by the therapist assigned to the participant, who will provide personalized feedback within three days of submission. Therapists have access to pre-designed session-specific feedback templates to use as a basic structure to write their feedback. By doing so, the time needed to respond to each patient is reduced and therefore the number of patients each therapist can handle increases. On average, developing this feedback takes a therapist 15-20 minutes per patient. In addition to the weekly feedback, participants have the option to message their therapist through the platform throughout the week regarding any questions or concerns they may have.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Stepped Care
2016
Completed Phase 4
~2380
e-CBT
2021
N/A
~200
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Who is running the clinical trial?
Dr. Nazanin AlaviLead Sponsor
12 Previous Clinical Trials
1,037 Total Patients Enrolled
5 Trials studying Depression
495 Patients Enrolled for Depression
Queen's UniversityLead Sponsor
369 Previous Clinical Trials
121,471 Total Patients Enrolled
32 Trials studying Depression
7,074 Patients Enrolled for Depression
Nazanin Alavi, MD, FRCPCPrincipal InvestigatorQueen's University
1 Previous Clinical Trials
100 Total Patients Enrolled
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