Psychological Preparation Prior to Bariatric Surgery
Primary Purpose
Obesity, Psychological Disorders
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Psychological preparation
Sponsored by
About this trial
This is an interventional other trial for Obesity
Eligibility 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
Sites / Locations
- Sheffield Teaching Hospitals NHS Foundation Trust
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
Psychological preparation
Surgery as usual
Arm Description
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
Patients will proceed to surgery as usual. They will complete psychological assessment forms at their follow up clinic sessions.
Outcomes
Primary Outcome Measures
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?
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
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?
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.
Full Information
NCT ID
NCT01670331
First Posted
July 10, 2012
Last Updated
November 22, 2017
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
1. Study Identification
Unique Protocol Identification Number
NCT01670331
Brief Title
Psychological Preparation Prior to Bariatric Surgery
Official Title
Psychological Preparation Prior to Bariatric Surgery: A Feasibility Study
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Completed
Study Start Date
March 2013 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
February 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
4. Oversight
Data Monitoring Committee
No
5. Study Description
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?
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity, Psychological Disorders
7. Study Design
Primary Purpose
Other
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
84 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Psychological preparation
Arm Type
Active Comparator
Arm Description
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
Arm Title
Surgery as usual
Arm Type
No Intervention
Arm Description
Patients will proceed to surgery as usual. They will complete psychological assessment forms at their follow up clinic sessions.
Intervention Type
Behavioral
Intervention Name(s)
Psychological preparation
Other Intervention Name(s)
Pre-bariatric surgery psychological programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
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?
Description
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.
Time Frame
12 months
Secondary Outcome Measure Information:
Title
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?
Description
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.
Time Frame
12 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corinne E Owers, MB/ChB
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Adam Saradjian, DClinPsy
Organizational Affiliation
Sheffield Teaching Hospitals NHS Foundation Trust
Official's Role
Principal Investigator
Facility Information:
Facility Name
Sheffield Teaching Hospitals NHS Foundation Trust
City
Sheffield
State/Province
South Yorkshire
ZIP/Postal Code
S5 7AU
Country
United Kingdom
12. IPD Sharing Statement
Learn more about this trial
Psychological Preparation Prior to Bariatric Surgery
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