Psychological Preparation Prior to Bariatric Surgery
This study is not yet open for participant recruitment.
Verified August 2012 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Sheffield Teaching Hospitals NHS Foundation Trust
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01670331
First received: July 10, 2012
Last updated: August 17, 2012
Last verified: August 2012
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Purpose
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 | Intervention |
|---|---|
|
Obesity Psychological Disorders |
Behavioral: Psychological preparation |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label |
| Official Title: | Psychological Preparation Prior to Bariatric Surgery: A Feasibility Study |
Resource links provided by NLM:
Further study details as provided by Sheffield Teaching Hospitals NHS Foundation Trust:
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? [ Time Frame: 12 months ] [ Designated as safety issue: No ]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 EDE-Q 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 ] [ Designated as safety issue: No ]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.
- Are there increased scores in the GAD-7 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 ] [ Designated as safety issue: No ]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.
- 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 ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 60 |
| Study Start Date: | October 2012 |
| Estimated Study Completion Date: | June 2014 |
| Estimated Primary Completion Date: | October 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
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.
|
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01670331
Contacts
| Contact: Corinne E Owers, MB/ChB | 07884176416 | corinneowers@doctors.org.uk |
| Contact: Roger Ackroyd, MB/ChB, MD | 01142434343 ext 52402 | roger.ackroyd@sth.nhs.uk |
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 |
More Information
No publications provided
| Responsible Party: | Sheffield Teaching Hospitals NHS Foundation Trust |
| ClinicalTrials.gov Identifier: | NCT01670331 History of Changes |
| Other Study ID Numbers: | STH16575 |
| Study First Received: | July 10, 2012 |
| Last Updated: | August 17, 2012 |
| Health Authority: | United Kingdom: National Health Service United Kingdom: Research Ethics Committee |
Additional relevant MeSH terms:
|
Mental Disorders Obesity Overnutrition Nutrition Disorders |
Overweight Body Weight Signs and Symptoms |
ClinicalTrials.gov processed this record on May 22, 2013