Tele-CBT Following Bariatric Surgery: Randomized Control Trial

University Health Network, Toronto

Status: Completed

Conditions: Obesity

Treatments: Behavioral: Telephone-Based CBT

Study type: Interventional

Funder types: Other

Identifiers

NCT03315247

17-5655

376045 (Other Grant/Funding Number)

Details and patient eligibility

About

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.

Enrollment: 306 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Received bariatric surgery 1 year ago
• Fluent in English
• Have Internet access to complete online questionnaires.

Exclusion criteria

• Current active suicidal ideation
• Current poorly controlled psychiatric illness that would render Tele-CBT very difficult, including serious mental illness (i.e., psychotic disorder, bipolar disorder), severe depression (i.e., current major depressive episode diagnosis and Patient Health Questionnaire [PHQ-9]61 score > 20), or severe anxiety (i.e., current anxiety disorder diagnosis and Generalized Anxiety Disorder [GAD-7]62 score >15)
• Current poorly controlled medical illness that would render Tele-CBT very difficult.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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306 participants in 2 patient groups

Treatment as Usual

No Intervention group

Description:

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.

Telephone-Based CBT

Experimental group

Description:

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.

Treatment:

Behavioral: Telephone-Based CBT