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Clinical Trials/NCT03976674
NCT03976674CompletedNot Applicable

Evaluation of a Preoperative Cognitive Behavioural Therapy (CBT) Program Based on Self-determination Theory for Bariatric Surgery Candidates : an Open-label Controlled, Randomized, Superiority Study

Lille Catholic University2 sites in 1 country94 target enrollmentStarted: February 5, 2018Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Sponsor
Enrollment
94
Locations
2
Primary Endpoint
Eating Disorder Examination-Questionnaire (EDE-Q) score

Study Overview

Brief Summary

The objective of this study is to evaluate the impact of a pre-surgical intervention program based on Cognitive and Behavioural Emotional Therapies, on the degree of dietary restriction of patients who are candidates for bariatric surgery in order to increase the long-term effectiveness of this kind of surgery

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Supportive Care
Masking
None

Eligibility Criteria

Ages
18 Years to 60 Years (Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Patient starting a preparation for bariatric surgery in the endocrinology department at St Philibert Hospital
  • 18 ≤Age≤60 years
  • Patient meeting the criteria of the High Authority of Health (HAS) for the agreement of a bariatric treatment
  • Patient affiliated to the social security
  • Patient giving informed consent

Exclusion Criteria

  • Low level of comprehension of French
  • Pregnant women
  • Patient under guardianship or curatorship.

Arms & Interventions

Patients in preparation for bariatric surgery

Experimental

Patients in preparation for bariatric surgery in the endocrinology department will follow a cognitive behavioural therapy

Intervention: Cognitive Behavioural Therapy (CBT) (Behavioral)

Control group

No Intervention

Standard practice

Outcomes

Primary Outcomes

Eating Disorder Examination-Questionnaire (EDE-Q) score

Time Frame: One year after therapy

The EDE-Q is a 28 item self-report questionnaire. It concerns behaviors over a 28-day time period and retains the scoring system of 0-6: 0 = behaviour was absent and 6 = behaviour was present daily or to an extreme degree

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor
Lille Catholic University
Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (2)

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