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Behavioral Intervention
Tele-CBT for Mental Health Disorders After Bariatric Surgery (TELE-BARICARE Trial)
N/A
Recruiting
Led By Stephanie E. Cassin, PhD, CPsych
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 baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Awards & highlights
TELE-BARICARE Trial Summary
This trial will study whether providing a convenient and accessible telephone-based psychotherapy during and potentially after the COVID-19 pandemic will lead to better mental health and disordered eating-related outcomes in patients managing obesity after weight loss surgery.
Who is the study for?
This trial is for English-speaking adults who've had bariatric surgery, can access the internet to fill out surveys, and show signs of depression or disordered eating. It's not for those with severe mental illness like psychosis or bipolar disorder, active suicidal thoughts, or an ongoing COVID-19 infection.Check my eligibility
What is being tested?
The study tests if phone-based cognitive behavioural therapy (Tele-CBT) helps reduce mental distress and improve eating behaviors in post-bariatric surgery patients during/after COVID-19. Participants are randomly placed into Tele-CBT sessions or a control group with check-ins and self-help resources.See study design
What are the potential side effects?
Since this trial involves psychotherapy rather than medication, traditional side effects aren't expected. However, discussing sensitive topics might temporarily increase emotional discomfort.
TELE-BARICARE Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline (pre-intervention, when participants are enrolled), post-intervention (approximately 3-months after patients complete baseline assessment), and 3-month follow-up (approximately 6 months after patients complete baseline assessment)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change in Binge Eating Scale
Change in Patient Health Questionnaire-9 Item Scale
Secondary outcome measures
Change in Generalized Anxiety Disorder-7 Item Scale
Change in Loss of Control Over Eating Scale
Emotional Eating Scale
+1 moreTELE-BARICARE Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Tele-CBT GroupExperimental Treatment1 Intervention
Participants will receive 6 weekly Tele-CBT sessions and 1 final "booster" session 1 month later, all approximately 55-minutes in duration. Briefly, the Tele-CBT sessions focus on introducing the cognitive behavioural model of overeating and obesity, scheduling healthy meals and snacks, scheduling pleasurable alternative activities to overeating, identifying and planning for difficult eating scenarios, and problem solving and challenging negative thoughts. Participants are encouraged to complete CBT homework between sessions (i.e., completing food records, pleasurable activities and worksheets). Five clinical psychology graduate students will work as study therapists under the supervision of Drs. Cassin and Sockalingam and will have biweekly case supervision meetings.
Group II: Self-Help Resources GroupActive Control1 Intervention
Participants will be directed to the CAMH COVID-19 Self-Help webpage (www.camh.ca/covid19) to access coping tools to help with COVID-19 associated stress and anxiety, loss, grief and healing, stigma, and physical isolation. Participants in the control arm will receive weekly check-in/reminder emails for the duration of the intervention period.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Tele-CBT
2023
N/A
~670
Find a Location
Who is running the clinical trial?
Toronto Metropolitan UniversityOTHER
83 Previous Clinical Trials
10,777 Total Patients Enrolled
Centre for Addiction and Mental HealthOTHER
354 Previous Clinical Trials
80,980 Total Patients Enrolled
2 Trials studying Mental Health Disorders
288 Patients Enrolled for Mental Health Disorders
Ryerson UniversityOTHER
76 Previous Clinical Trials
7,759 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active COVID-19 infection.I have had weight loss surgery.I am currently having thoughts about harming myself.
Research Study Groups:
This trial has the following groups:- Group 1: Tele-CBT Group
- Group 2: Self-Help Resources Group
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.
What is the extent of enrolment for this investigation?
"Affirmative, the information found on clinicaltrials.gov states that this research is actively enrolling patients. Initially posted October 6th 2022, the trial aims to recruit 140 volunteers at 4 distinct centres of care."
Answered by AI
Is the age range for recruitment in this trial inclusive of those 25 and older?
"The entry requirements for this medical trial specify that participants must be at least 18 years of age, and not exceed 70."
Answered by AI
Is this scientific investigation still accepting participants?
"Affirmative. Clinicaltrials.gov reports that this research endeavor, which was originally announced on October 6th 2022, is currently recruiting patients. Approximately 140 volunteers must be recruited from 4 centers for the trial's completion."
Answered by AI
What is the primary objective of this medical experiment?
"This clinical trial aims to assess Change in Patient Health Questionnaire-9 Item Scale over a Baseline, post-intervention and 3-month follow up duration. Secondary objectives include analysing the patient's response to Loss of Control Over Eating Scale (LOCES), Emotional Eating Scale (EES) and Generalized Anxiety Disorder-7 Item Scale (GAD-7)."
Answered by AI
What criteria must be met to qualify for participation in this experiment?
"To participate, prospective patients should meet the criteria of having obesity and being between 18 to 70 years old. This clinical trial is presently searching for 140 individuals."
Answered by AI
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