NCT01670331|Completed
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Sponsor study identifier
interventional
84
1 country
1
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
June 2016
Actual (reported)Study Completion
February 2017
Actual (reported)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?
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
February 2017
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
July 10, 2012
Actual (reported)August 22, 2012
Actual (reported)March 2013
Date type not reportedThis date has not been verified as actual or estimated.
June 2016
Actual (reported)February 2017
Actual (reported)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.
12 months
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?
12 months
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.
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Sheffield Teaching Hospitals NHS Foundation Trust
Sheffield, South Yorkshire, S5 7AU, United Kingdom
Corinne E Owers, MB/ChB
Sheffield Teaching Hospitals NHS Foundation Trust
Adam Saradjian, DClinPsy
Sheffield Teaching Hospitals NHS Foundation Trust
84 participants (actual enrollment reported by the registry).
First Submitted
July 10, 2012
First Posted
August 22, 2012
Study Start
March 2013
Date type not reportedThis date has not been verified as actual or estimated.
Flintstone Foods 1
Contact the study team to confirm eligibility.
Primary Completion
June 2016
Actual (reported)Study Completion
February 2017
Actual (reported)Last Updated
November 24, 2017
Record last verified: 2017-11
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Source: ClinicalTrials.gov.
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