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Tele-CBT for Obesity
N/A
Waitlist Available
Led By Sanjeev Sockalingam, MD, FRCPC
Research Sponsored by University Health Network, Toronto
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 1.25, 1.5, 2, 3 years post-surgery
Awards & highlights
Study Summary
This trial is testing whether adding a seven-session cognitive behavioral therapy intervention focused on developing coping skills to improve thoughts, emotions, and eating behaviors to the usual standard of care for bariatric surgery patients will lead to increased weight loss two years after surgery.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1.25, 1.5, 2, 3 years post-surgery
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1.25, 1.5, 2, 3 years post-surgery
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Weight
Secondary outcome measures
Changes in eating pathology - Anxiety
Changes in eating pathology - Binge Eating
Changes in eating pathology - Depression
+6 moreTrial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Telephone-Based CBTExperimental Treatment1 Intervention
The Tele-CBT intervention will be delivered 1 year following bariatric surgery. Participants will receive 6 weekly Telephone-based Cognitive Behavioural Therapy sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration and scheduled at a time convenient for the participants.
Group II: Treatment as UsualActive Control1 Intervention
Participants assigned to the Treatment as Usual group will attend routine clinic visits at the Toronto Western Hospital Bariatrics Surgery Program (TWH-BSP). These visits generally include education on bariatric surgery and nutrition. Patients meet with select members of the multidisciplinary team at 1, 2, and 3 years post-surgery, and may attend an optional monthly support group. Participants' service utilization (i.e., attendance at optional sessions) will be documented and compared across groups.
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Who is running the clinical trial?
University Health Network, TorontoLead Sponsor
1,468 Previous Clinical Trials
484,140 Total Patients Enrolled
12 Trials studying Obesity
587 Patients Enrolled for Obesity
Lorraine Lipscombe, MD, FRCPCStudy DirectorWomen's College Hospital
Susan Wnuk, PhD, CPsychStudy DirectorUniversity of Toronto, University Health Network
1 Previous Clinical Trials
32 Total Patients Enrolled
1 Trials studying Obesity
32 Patients Enrolled for Obesity
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Eligibility Criteria:
This trial includes the following eligibility criteria:- You had weight loss surgery one year ago.You are currently having thoughts of hurting yourself.You have a mental illness that is not well-controlled and could make it difficult for you to participate in Tele-CBT. This could include serious mental illnesses like psychosis or bipolar disorder, or severe depression and anxiety.
Research Study Groups:
This trial has the following groups:- Group 1: Telephone-Based CBT
- Group 2: Treatment as Usual
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.
Does this trial permit individuals exceeding forty years of age to participate?
"The age cap for this clinical trial is 65 years while the minimum allowable age to join it 18."
Answered by AI
Are there still open slots available for enrollees in this experiment?
"Correct. Clinicaltrials.gov reveals that, following its initial posting on February 9th 2018 and subsequent editing on May 16th 2022, no further participants are required for this medical experiment; however there remain almost a thousand other trials in need of volunteers at present time."
Answered by AI
What prerequisites must be met to join this clinical trial?
"The study is open to 350 individuals between 18 and 65 years of age who have obesity. In addition, they must have undergone bariatric surgery in the last 12 months, possess fluency in English, and be able to complete online questionnaires via the internet."
Answered by AI
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