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Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be between 18 and 65 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline, week 6, week 12
Awards & highlights
Study Summary
This trial aims to study the feasibility and effectiveness of e-CBT for treating patients with bipolar II disorder who have residual depressive symptoms.
Who is the study for?
This trial is for individuals with Bipolar Disorder II (BAD-II) currently experiencing depressive symptoms. They must have reliable internet access, understand and speak English, and be able to consent to participate. People are excluded if they've had CBT in the last year, show active suicidal or homicidal thoughts, are in a hypomanic/manic phase, have acute psychosis or severe substance abuse issues.Check my eligibility
What is being tested?
The study tests electronic Cognitive Behavioural Therapy (e-CBT) using a secure platform called OPTT versus usual treatment for managing depression in BAD-II patients. It involves weekly modules and homework reviewed by clinicians over 12 weeks. The effectiveness will be measured through questionnaires and interviews.See study design
What are the potential side effects?
Since e-CBT is a non-medical therapy focusing on mental health exercises and communication with therapists online, it does not have traditional side effects like medications do; however, participants may experience emotional discomfort addressing psychological issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline, week 6, week 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline, week 6, week 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 symptoms (Modified Clinical Global Impression Scale for Bipolar Disorder - CGI-BP-M)
Change in symptoms (Montgomery Asberg Depression Rating Scale - MADRS)
Change in symptoms (Young Mania Rating Scale - YMRS)
Secondary outcome measures
Differences in personal, social, and cultural factors impacting accessibility to treatment
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: e-CBTExperimental Treatment1 Intervention
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.
Group II: Treatment as UsualActive Control1 Intervention
Participants will continue with treatment as usual and any lifestyle activities (diet, exercise, medication, etc.)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
e-CBT
2021
N/A
~200
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Who is running the clinical trial?
Dr. Nazanin AlaviLead Sponsor
12 Previous Clinical Trials
1,036 Total Patients Enrolled
Queen's UniversityLead Sponsor
365 Previous Clinical Trials
120,337 Total Patients Enrolled
6 Trials studying Bipolar Disorder
397 Patients Enrolled for Bipolar Disorder
Online PsychoTherapy ClinicOTHER
8 Previous Clinical Trials
621 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You can easily and consistently connect to the internet.Your depression severity score falls between 7 and 34 on the MADRS scale.You are currently undergoing or have undergone cognitive-behavioral therapy (CBT) within the past year.You have been diagnosed with Bipolar Disorder - 2.You are currently thinking about hurting yourself or someone else.You are currently experiencing a sudden and intense change in mood that makes you feel overly excited or energized.You are currently experiencing sudden and severe mental health issues such as hallucinations or delusions.You have a serious problem with alcohol or drug abuse.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment as Usual
- Group 2: e-CBT
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are seniors being enrolled in this experiential investigation?
"The age restriction for this trial is 18-55 years old."
Answered by AI
Is this experiment currently accepting volunteers?
"As of present, the information found on clinicaltrials.gov confirms that this medical study is recruiting patients. The trial was initially made available to the public on March 1st 2020 and has been updated as recently as October 14th 2022."
Answered by AI
Is there eligibility criteria that allows me to join this research endeavor?
"The enrolment criteria for this study necessitates that participants have a manic disorder and be between the ages of 18 to 55. Altogether, 80 individuals will be accepted into the trial."
Answered by AI
What is the scope of enrollment for this clinical research?
"Affirmative, the information on clinicaltrials.gov suggests that this medical trial is actively searching for volunteers. The investigation was first launched on March 1st 2020 and was revised on October 14th 2022; it aims to recruit 80 individuals at a single research centre."
Answered by AI
Who else is applying?
What state do they live in?
Kentucky
What portion of applicants met pre-screening criteria?
Did not meet criteria
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