Telephone-based Cognitive Behavioral Therapy for Bariatric Surgery Patients: A Pilot Study

NCT ID: NCT01508585

Last Updated: 2015-07-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-03-31

Study Completion Date

2014-12-31

Brief Summary

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Bariatric surgery is the most effective treatment for patients with extreme obesity. Psychological interventions are not routinely offered in Bariatric Surgery Programs. Preliminary evidence suggests that Cognitive Behavioral Therapy (CBT) might be effective in reducing binge eating and improving surgical outcomes. The current study will examine whether the addition of telephone-based CBT (Tele-CBT) to the usual standard of care is more effective than the usual standard of care alone, and whether it is more effective when delivered prior to or following bariatric surgery.

Detailed Description

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Preliminary research suggests that CBT might be effective in reducing eating pathology and improving surgical outcomes.

However, previous studies have examined group-based CBT delivered in person, and most patients cannot feasibly attend weekly therapy appointments at the hospital. Telephone-based CBT offers greater convenience because the service can be delivered during the evening and weekends, and eliminates the need to leave work and travel to hospital appointments. No published studies have examined the effectiveness or feasibility of telephone-based CBT for bariatric surgery patients. This study will examine the effectiveness of Tele-CBT as an adjunctive treatment to the usual standard of care in bariatric surgery patients.

Conditions

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Obesity Eating Disorder

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Pre-Op CBT

This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) before bariatric surgery

Group Type ACTIVE_COMPARATOR

Telephone Based Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.

Post-Op CBT

This group will receive CBT (Telephone Based Cognitive Behavioral Therapy) after bariatric surgery

Group Type ACTIVE_COMPARATOR

Telephone Based Cognitive Behavioral Therapy

Intervention Type BEHAVIORAL

6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.

Interventions

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Telephone Based Cognitive Behavioral Therapy

6 sessions of Cognitive Behavioral Therapy (CBT), lasting approximately 60 minutes each.

Intervention Type BEHAVIORAL

Other Intervention Names

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Tele-CBT

Eligibility Criteria

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Inclusion Criteria

* Fluent in English
* Have access to telephone and computer with internet access
* Have the capacity to provide informed consent

Exclusion Criteria

* Active suicidal ideation
* Serious mental illness
* Active severe depression
* Active severe anxiety
* Active post traumatic stress disorder
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University Health Network, Toronto

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Sagar V Parikh, MD, FRCPC

Role: PRINCIPAL_INVESTIGATOR

University Health Network, Toronto

Raed Hawa, MD,

Role: STUDY_DIRECTOR

University Health Network, Toronto

Stephanie Cassin, MD

Role: STUDY_DIRECTOR

University Health Network, Toronto

Susan Wnuk, MD

Role: STUDY_DIRECTOR

University Health Network, Toronto

Rachel Strimas

Role: STUDY_DIRECTOR

University Health Network, Toronto

Sanjeev Sockalingam, MD,FRCPC

Role: STUDY_DIRECTOR

University Health Network, Toronto

References

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Cassin SE; Sockalingam S; Wnuk S; Strimas R; Royal S; Hawa, R; & Parikh S. Cognitive behavioural therapy for bariatric surgery patients: Preliminary evidence for feasibility, acceptability, and effectiveness. Cognitive and Behavioral Practice 20: 529-543, 2013.

Reference Type BACKGROUND

Other Identifiers

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11-0622-BE

Identifier Type: -

Identifier Source: org_study_id

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