Ignite Creation Date:
2024-05-06 @ 3:31 PM
Last Modification Date:
2024-10-26 @ 1:51 PM
Study NCT ID:
NCT04664257
Status:
RECRUITING
Last Update Posted:
2024-04-10
First Post:
2020-12-05
Brief Title:
Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms
Sponsor:
Dr Nazanin Alavi
Organization:
Queens University
Study Overview
Official Title:
Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms
Status:
RECRUITING
Status Verified Date:
2024-04
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The lifetime prevalence of Bipolar II is 04 with the time spent with depressive symptoms outnumbering the time spent with hypomanic symptoms by 35 to 1 Regarding current treatment options psychotherapy is effective for managing depressive symptoms with CBT being particularly efficacious Unfortunately CBT is often not a feasible treatment option Electronic CBT e-CBT is more accessible for treating various mental illnesses with evidence suggesting it can increase treatment adherence and patient satisfaction Moreover e-CBT is suggested to have comparable outcomes to in-person CBT in the treatment of depression and anxiety Typically patient-clinician interactions of e-CBT are administered through email however this is an insecure unsustainable and non-scalable treatment delivery method The proposed study will use the Online Psychotherapy Tool OPTT a secure cloud-based platform for the delivery of e-CBT The aim is to evaluate the feasibility and effectiveness of using OPTT for the treatment of BAD-II with depressive symptoms while also analyzing social cultural and personal factors affecting patients experience Participants n 80 diagnosed with BAD-II in a depressive episode will be recruited from the Mood and Anxiety Clinic at Providence Care Hospital in Kingston Ontario Canada Eligible participants will then be randomly assigned to either the treatment group e-CBT plus treatment as usual TAU n 40 or the control group TAU n 40 where they will complete the 12-week program Participants in the TAU group will be offered the e-CBT program after the first 12 weeks if they wish to take part Participants in the e-CBT group will complete weekly modules mirroring in-person CBT content and complete homework assignments that will be evaluated by a clinician who will provide personalized feedback through OPTT Progressionregression of participants will be analyzed using the MADRS YMRS and CGI-BP-M questionnaires administered at baseline after week 6 and after week 12 Personal social and cultural factors impacting participant experience will be investigated through an in-depth interview utilizing focus groups The findings from this study will be the first on the effectiveness of delivering e-CBT to patients with BAD-II with residual depressive symptoms This approach can provide an innovative method to address the barriers associated with in-person psychotherapy
Detailed Description:
Population Individuals n 80 diagnosed with BAD-II who are experiencing an acute depressive episode will be recruited from the Mood and Anxiety Clinic at Providence Care Hospital PCH in Kingston Ontario Canada Inclusion criteria include being between 18 and 55 years of age at the start of the study a confirmed diagnosis of BAD-II according to Diagnostic and Statistical Manual of Mental Health Disorders 5th Edition DSM-5 a Montgomery Åsberg Depression Rating Scale MADRS score between 7 and 34 competence to consent and participate the ability to speak and read English and having consistent and reliable access to the internet Exclusion criteria include experiencing a current acute hypomanicmanic episode acute psychosis severe alcohol or substance use disorder and active suicidal andor homicidal ideation Additionally if an individual is currently receiving or has received CBT in the past year they will be excluded from the study To confirm eligibility participants will undergo a complete assessment from a clinician where the diagnosis will be confirmed using the DSM-5 and a Mini-International National Interview MINI version 702 Eligible participants will be randomly allocated into either the e-CBT plus treatment as usual TAU n 40 or the control group TAU exclusively n 40 Participants in the control group will be offered the e-CBT program after the first 12 weeks of the study if they are interested
Procedure Upon completion of the initial assessment if eligible for the study participants from the e-CBT group will be enrolled in the e-CBT program All e-CBT sessions will be administered through OPTT and will consist of approximately 30 slides per week The content and format of each weekly online session will be designed to mirror in-person CBT for the treatment of BAD-II Participants will complete the module and submit the assigned homework to their clinician through OPTT where the clinician will be able to provide personalized feedback These pre-designed engaging and multimedia modules will be able to streamline the therapy process helping care providers save time on repeating similar materials to all patients and focusing on delivering personalized feedback to each patient The slides will highlight a different topic each week and include general information an overview of skills and homework that is to be completed within that week All weekly sessions have an estimated completion time of 50 minutes During the 12 weeks both groups will continue with their TAU To ensure the quality and consistency of care care pathways will be fully assigned beforehand and a clinician will be trained to follow the standard care pathways Through the training the clinician will learn the aim and content of each therapeutic session and will be provided with sample homework submissions and modules to better understand how to structure feedback
Procedure Upon completion of the initial assessment if eligible for the study participants from the e-CBT group will be enrolled in the e-CBT program All e-CBT sessions will be administered through OPTT and will consist of approximately 30 slides per week The content and format of each weekly online session will be designed to mirror in-person CBT for the treatment of BAD-II Participants will complete the module and submit the assigned homework to their clinician through OPTT where the clinician will be able to provide personalized feedback These pre-designed engaging and multimedia modules will be able to streamline the therapy process helping care providers save time on repeating similar materials to all patients and focusing on delivering personalized feedback to each patient The slides will highlight a different topic each week and include general information an overview of skills and homework that is to be completed within that week All weekly sessions have an estimated completion time of 50 minutes During the 12 weeks both groups will continue with their TAU To ensure the quality and consistency of care care pathways will be fully assigned beforehand and a clinician will be trained to follow the standard care pathways Through the training the clinician will learn the aim and content of each therapeutic session and will be provided with sample homework submissions and modules to better understand how to structure feedback
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None