Bipolar DisorderNCT04664257
Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms
A study testing e-CBT in people with Bipolar Disorder and Bipolar Depression, run by Dr. Nazanin Alavi at 1 site in Canada.
Trial summary
The lifetime prevalence of Bipolar II is 0.4% 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Bipolar Disorder, Bipolar Depression
- What is being tested?
- e-CBT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteCanada
- Study dates
- 1 Mar 2020to Dec 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Diagnosis of Bipolar Disorder - 2
- MADRS score of 7-34
- Competence to consent and participate
- Ability to speak and read English
- Consistent and reliable access to the internet
Who cannot join
- Acute hypomanic/manic episodes
- Acute psychosis
- Severe alcohol or substance use disorder
- Active suicidal and/or homicidal ideation
- Currently receiving/has received CBT in the past year
Trial locations and contacts
1 site in 1 country.
Canada1 site, 1 recruiting
- Recruiting
Hotel Dieu Hospital
Kingston, Ontario, K7L 5G3
Nazanin Alavi, 6479672079, nazanin.alavitabari@kingstonhsc.ca
About this study
The lifetime prevalence of Bipolar II is 0.4% 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. Progression/regression 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.
Read the 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 hypomanic/manic episode, acute psychosis, severe alcohol or substance use disorder, and active suicidal and/or 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 7.0.2. 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.
- Conditions
- Bipolar Disorder, Bipolar Depression
- Being tested
- e-CBT
- Keywords
- Bipolar Disorder, Bipolar Depression, Cognitive Behavioural Therapy, Virtual Mental Health Care, Psychotherapy
- Medical subject headings
- Bipolar Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
e-CBTBehavioural
e-CBT will be administered with weekly modules. See arm/group descriptions for more information.
| Study group | Role | What they receive |
|---|---|---|
| e-CBT | Experimental | 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. Receives: Behavioral: e-CBT |
| Treatment as Usual | No intervention | Participants will continue with treatment as usual and any lifestyle activities (diet, exercise, medication, etc.) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS)
Clinically validated symptom questionnaire. Scale of 1-6, 6 is worse.
Measured: Baseline, week 6, week 12
Change in symptoms (Young Mania Rating Scale - YMRS)
Clinically validated symptom questionnaire. Scale of 1-4 and 1-8, higher is worse.
Measured: Baseline, week 6, week 12
Change in symptoms (Modified Clinical Global Impression Scale for Bipolar Disorder - CGI-BP-M)
Clinically validated symptom questionnaire. Scale of 1-7 and 1-8, higher is worse.
Measured: Baseline, week 6, week 12
Secondary outcomes (1)
Differences in personal, social, and cultural factors impacting accessibility to treatment
Focus groups for providers and patients using Interpretive Phenomenological Analysis
Measured: Week 12 (Post-Treatment)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2020
- Study start1 Mar 2020
- Primary completionDec 2024 (estimated)
- Study completionDec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Bipolar DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomly assigned to intervention or control
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dr. Nazanin Alavi
- Sponsor type
- University, hospital or other
- Collaborators
- Online PsychoTherapy Clinic
- Responsible party
- Sponsor-investigator, Dr. Nazanin Alavi, Queen's University
- Investigators
- Nazanin Alavi, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04664257
- Sponsor's protocol ID
- PHRY-057-20
- Status last verified
- Apr 2024
- First submitted
- 5 Dec 2020
- Last updated
- 10 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Gutierrez G, Stephenson C, Eadie J, Moghimi E, Omrani M, Groll D, Soares CN, Milev R, Vazquez G, Yang M, Alavi N. Evaluating the Efficacy of Web-Based Cognitive Behavioral Therapy for the Treatment of Patients With Bipolar II Disorder and Residual Depressive Symptoms: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 May 19;12:e46157. doi: 10.2196/46157.
PubMed 37140460
Study at a glance
From the registry record, last updated by the sponsor on 10 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Delivering Electronic Cognitive Behavioural Therapy to Patients With Bipolar Disorder and Residual Depressive Symptoms
- ClinicalTrials.gov ID
- NCT04664257
- Acronym / sponsor ID
- PHRY-057-20
- Conditions
- Bipolar Disorder, Bipolar Depression
- Keywords
- Bipolar Disorder, Bipolar Depression, Cognitive Behavioural Therapy, Virtual Mental Health Care, Psychotherapy
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Dr. Nazanin AlaviUniversity, hospital or other
- Collaborators
- Online PsychoTherapy Clinic
- Study start
- 1 Mar 2020 (actual)
- Primary completion
- Dec 2024 (estimated)
- Study completion
- Dec 2025 (estimated)
- First posted
- 11 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The lifetime prevalence of Bipolar II is 0.4% 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. Progression/regression 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 hypomanic/manic episode, acute psychosis, severe alcohol or substance use disorder, and active suicidal and/or 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 7.0.2. 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomly assigned to intervention or control
| Arm | Type | Receives |
|---|---|---|
| e-CBT | Experimental | Behavioral: e-CBTAll 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. |
| Treatment as Usual | No intervention | –Participants will continue with treatment as usual and any lifestyle activities (diet, exercise, medication, etc.) |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Diagnosis of Bipolar Disorder - 2
- MADRS score of 7-34
- Competence to consent and participate
- Ability to speak and read English
- Consistent and reliable access to the internet
Key exclusion criteria (5 listed)
- Acute hypomanic/manic episodes
- Acute psychosis
- Severe alcohol or substance use disorder
- Active suicidal and/or homicidal ideation
- Currently receiving/has received CBT in the past year
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| e-CBTe-CBT will be administered with weekly modules. See arm/group descriptions for more information. | Behavioural | e-CBT |
Primary outcome
Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS)
Time frame: Baseline, week 6, week 12
Clinically validated symptom questionnaire. Scale of 1-6, 6 is worse.
Change in symptoms (Young Mania Rating Scale - YMRS)
Time frame: Baseline, week 6, week 12
Clinically validated symptom questionnaire. Scale of 1-4 and 1-8, higher is worse.
Change in symptoms (Modified Clinical Global Impression Scale for Bipolar Disorder - CGI-BP-M)
Time frame: Baseline, week 6, week 12
Clinically validated symptom questionnaire. Scale of 1-7 and 1-8, higher is worse.
1 secondary outcome
Differences in personal, social, and cultural factors impacting accessibility to treatment
Time frame: Week 12 (Post-Treatment)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Apr 2024.
- Derived from this study: PubMed 37140460Gutierrez G, Stephenson C, Eadie J, Moghimi E, Omrani M, Groll D, Soares CN, Milev R, Vazquez G, Yang M, Alavi N. Evaluating the Efficacy of Web-Based Cognitive Behavioral Therapy for the Treatment of Patients With Bipolar II Disorder and Residual Depressive Symptoms: Protocol for a Randomized Controlled Trial. JMIR Res Protoc. 2023 May 19;12:e46157. doi: 10.2196/46157.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nazanin Alavi principal investigator
Queen's University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing e-CBT in people with Bipolar Disorder and Bipolar Depression, run by Dr. Nazanin Alavi at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 10 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Nazanin Alavi (613 544 4900 ext. 73002, nazanin.alavitabari@kingstonhsc.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS) (time frame: Baseline, week 6, week 12). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04664257, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Apr 2024.