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Psychological Preparation Prior to Bariatric Surgery

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Sheffield Teaching Hospitals NHS Foundation Trust
Sponsor:
Information provided by (Responsible Party):
Sheffield Teaching Hospitals NHS Foundation Trust
ClinicalTrials.gov Identifier:
NCT01670331
First received: July 10, 2012
Last updated: August 23, 2013
Last verified: August 2013
  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: March 2013
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 Recruiting
Sheffield, South Yorkshire, United Kingdom, S5 7AU
Contact: Roger Ackroyd, MB/ChB    01142434343 ext 52402    roger.ackroyd@sth.nhs.uk   
Principal Investigator: Corinne E Owers, Mb/ChB         
Sub-Investigator: Adam Saradjian, DClinPsy         
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 23, 2013
Health Authority: United Kingdom: National Health Service
United Kingdom: Research Ethics Committee

Additional relevant MeSH terms:
Mental Disorders

ClinicalTrials.gov processed this record on November 20, 2014