Psychological Preparation Prior to Bariatric Surgery

Obesity Clinical Trial

Official title:

Psychological Preparation Prior to Bariatric Surgery: A Feasibility Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01670331
• Other study ID #: STH16575
• Status: Completed
• Phase: N/A
• First received: July 10, 2012
• Last updated: November 22, 2017
• Start date: March 2013
• Est. completion date: February 2017

Study information

• Verified date: November 2017
• Source: Sheffield Teaching Hospitals NHS Foundation Trust
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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?

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 84
• Est. completion date: February 2017
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Mental Disorders
• Obesity
• Psychological Disorders

Intervention

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.

Locations

Country	Name	City	State
United Kingdom	Sheffield Teaching Hospitals NHS Foundation Trust	Sheffield	South Yorkshire

Sponsors (1)

Lead Sponsor	Collaborator
Sheffield Teaching Hospitals NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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.	12 months