Psychological Preparation Prior to Bariatric Surgery

NCT01670331 | Completed

• 1 other identifier: STH16575
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

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?

Conditions

Obesity; Psychological Disorders

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• 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

Study Arms (2)

Psychological preparation

ACTIVE COMPARATOR

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

Surgery as usual

NO INTERVENTION

Patients will proceed to surgery as usual. They will complete psychological assessment forms at their follow up clinic sessions.

Interventions

Psychological preparation BEHAVIORAL

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.

Also known as: Pre-bariatric surgery psychological programme

Psychological preparation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• New referrals to the Sheffield Teaching Hospital Bariatric service

You may not qualify if:

• Non-English speakers
• Patients that are not fit for bariatric surgery
• Patients that have already seen the bariatric psychologist

Sponsors & Collaborators

• Sheffield Teaching Hospitals NHS Foundation Trust: lead

Study Sites (1)

Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, S5 7AU, United Kingdom

Location

MeSH Terms

Conditions

Obesity; Mental Disorders

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Corinne E Owers, MB/ChB

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

• Adam Saradjian, DClinPsy

  Sheffield Teaching Hospitals NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2012
• First Posted: August 22, 2012
• Study Start: March 1, 2013
• Primary Completion: June 1, 2016
• Study Completion: February 1, 2017
• Last Updated: November 24, 2017

Record last verified: 2017-11

Locations

GB (1)