Study 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.
- Mental Health Disorders
- Obesity
- Eating Disorders
- Bariatric Surgery Candidates
Treatment Effectiveness
Phase-Based Effectiveness
Study Objectives
2 Primary · 4 Secondary · Reporting Duration: 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)
Trial Safety
Phase-Based Safety
Awards & Highlights
Trial Design
2 Treatment Groups
Self-Help Resources Group
1 of 2
Tele-CBT Group
1 of 2
Active Control
Experimental Treatment
140 Total Participants · 2 Treatment Groups
Primary Treatment: Tele-CBT · No Placebo Group · N/A
Trial Logistics
Trial Timeline
Who is running the clinical trial?
Eligibility Criteria
Age 18 - 70 · All Participants · 1 Total Inclusion Criteria
Mark “Yes” if the following statements are true for you:- Sockalingam, Sanjeev, Samantha Eve Leung, Branka Agic, Clement Ma, Raed Hawa, Susan Wnuk, Satya Dash, et al.. 2022. “Telephone-based Cognitive Behavioural Therapy for Patients with Postoperative Bariatric Surgery to Manage COVID-19 Pandemic-related Mental Health Issues and Distress (TELE-BARICARE): A Protocol for a Randomised Controlled Trial”. BMJ Open. BMJ. doi:10.1136/bmjopen-2022-067393.
- 2022. "Tele-BARICARE to Manage COVID-19-Related Distress". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05258578.
Frequently Asked Questions
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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." - Anonymous Online Contributor
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)." - Anonymous Online Contributor
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." - Anonymous Online Contributor