Ignite Creation Date:
2024-05-06 @ 10:39 AM
Last Modification Date:
2024-10-26 @ 12:33 PM
Study NCT ID:
NCT03315247
Status:
COMPLETED
Last Update Posted:
2024-05-10
First Post:
2017-08-31
Brief Title:
Tele-CBT Following Bariatric Surgery Randomized Control Trial
Sponsor:
University Health Network Toronto
Organization:
University Health Network Toronto
Study Overview
Official Title:
Telephone-Based Cognitive Behavioural Therapy for Post-Operative Bariatric Surgery Patients A Randomized Controlled Trial
Status:
COMPLETED
Status Verified Date:
2024-05
Last Known Status:
Active not recruiting
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Bariatric weight loss surgery is the most effective treatment for extreme obesity but surgery does not treat underlying psychological and behavioural issues Currently psychotherapy talk therapy for eating problems is not routinely offered with surgery and many people start to regain weight one year later Objective This study will examine if adding a convenient and accessible psychotherapy by phone one year after surgery will lead to increased weight loss two years after surgery Primary Hypothesis Relative to the Control group who will get routine care the group of individuals who get psychotherapy will have lower weights 2 years after surgery Secondary Hypotheses Relative to the Control group the psychotherapy group will report significantly less maladaptive eating behaviours and medical burden and significantly greater quality of life Method Participants recruited from the Bariatric Surgery Programs at Toronto Western Hospital will be randomly assigned to 1 of 2 groups 1 Control Usual Standard of Care or 2 Tele-CBT a 7-session telephone-based cognitive behavioural therapy a type of talk therapy intervention focused on developing coping skills to improve maladaptive thoughts emotions and eating behaviours specifically designed for bariatric surgery patients delivered 1 year post-surgery They will have their weight measured and will complete measures of eating behaviour and quality of life prior to the intervention and again at several time points extending to 2 years post-surgery Implications If Telephone-Cognitive Behavioural Therapy CBT is found to improve bariatric surgery outcomes it could become the standard of care in Canadian bariatric surgery programs and beyond and be routinely offered to patients who cannot feasibly attend CBT sessions due to physical or practical barriers
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| 376045 | OTHER_GRANT | Canadian Institutes of Health Research CIHR | None |