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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
Sheffield Teaching Hospitals NHS Foundation Trust
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional other trial for Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

First Posted
July 10, 2012
Last Updated
November 22, 2017
Sponsor
Sheffield Teaching Hospitals NHS Foundation Trust
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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

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Psychological Preparation Prior to Bariatric Surgery

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