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Psychological Preparation Prior to Bariatric Surgery

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ClinicalTrials.gov Identifier: NCT01670331
Recruitment Status : Completed
First Posted : August 22, 2012
Last Update Posted : November 24, 2017
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust

Brief Summary:
Is it feasible to perform a randomized controlled trial to assess whether or not psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial to the investigators patients?

Condition or disease Intervention/treatment Phase
Obesity Psychological Disorders Behavioral: Psychological preparation Not Applicable

Detailed Description:
This is a feasibility study, assessing how possible it would be to perform a randomized controlled trial to see if preoperative psychological or mental health problems impacts on length of stay, short and long term health outcomes, weight loss, and if preoperative counseling has any effect.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 84 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Other
Official Title: Psychological Preparation Prior to Bariatric Surgery: A Feasibility Study
Study Start Date : March 2013
Actual Primary Completion Date : June 2016
Actual Study Completion Date : February 2017

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Psychological preparation
Patients undergo 3 seminar sessions with the bariatric psychologist prior to their surgery. These will aim to prepare them for the lifestyle changes that will occur / they will have to make after surgery
Behavioral: Psychological preparation

Session 1: Help patients understand their relationship to food. Patients complete a 'food diary' as 'homework'. Give information about lifestyle changes after surgery. Presents the model of 'stress' and how it influences 'overeating', to develop a more balanced lifestyle and better QoL.

Session 2: 'Intervention' using Compassion Focussed Therapy model to understand relationship to food from their diary. Help develop a 'minimising overeating plan' (a 'relapse prevention' plan). Help learn to meet needs in other ways than food.

Session 3: Focus on physical body. Current body image, explore hopes and expectations for after surgery. Consider how to manage changes to social reactions and sexual relationships that may occur.

Other Name: Pre-bariatric surgery psychological programme

No Intervention: Surgery as usual
Patients will proceed to surgery as usual. They will complete psychological assessment forms at their follow up clinic sessions.



Primary Outcome Measures :
  1. Are there increased scores in the BAROS psychometric tests in patients that undergo psychological preparation prior to bariatric surgery, than in those that do not at 12 months? [ Time Frame: 12 months ]
    At 12 months, patients will attend clinic and complete a battery of psychological assessment questionnaires and the results compared to see if there is a quantifiable difference in the quality of life and mental health outcomes of patients that undergo preparation seminars and those that do not.


Secondary Outcome Measures :
  1. Are there increased scores in the PHQ-9 psychometric tests in patients that undergo psychological preparation prior to bariatric surgery, than in those that do not at 12 months? [ Time Frame: 12 months ]
    At 12 months, patients will attend clinic and complete a battery of psychological assessment questionnaires and the results compared to see if there is a quantifiable difference in the quality of life and mental health outcomes of patients that undergo preparation seminars and those that do not.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • New referrals to the Sheffield Teaching Hospital Bariatric service

Exclusion Criteria:

  • Non-English speakers
  • Patients that are not fit for bariatric surgery
  • Patients that have already seen the bariatric psychologist

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01670331


Locations
United Kingdom
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Sponsors and Collaborators
Sheffield Teaching Hospitals NHS Foundation Trust
Investigators
Principal Investigator: Corinne E Owers, MB/ChB Sheffield Teaching Hospitals NHS Foundation Trust
Principal Investigator: Adam Saradjian, DClinPsy Sheffield Teaching Hospitals NHS Foundation Trust

Responsible Party: Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT01670331     History of Changes
Other Study ID Numbers: STH16575
First Posted: August 22, 2012    Key Record Dates
Last Update Posted: November 24, 2017
Last Verified: November 2017

Additional relevant MeSH terms:
Mental Disorders