Psychological Preparation Prior to Bariatric Surgery

NCT ID: NCT01670331

Last Updated: 2017-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

84 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-03-31

Study Completion Date

2017-02-28

Brief Summary

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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?

Detailed Description

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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.

Conditions

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Obesity Psychological Disorders

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

NONE

Study Groups

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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

Group Type ACTIVE_COMPARATOR

Psychological preparation

Intervention Type 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.

Surgery as usual

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

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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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.

Intervention Type BEHAVIORAL

Other Intervention Names

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Pre-bariatric surgery psychological programme

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Sheffield Teaching Hospitals NHS Foundation Trust

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Corinne E Owers, MB/ChB

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Adam Saradjian, DClinPsy

Role: PRINCIPAL_INVESTIGATOR

Sheffield Teaching Hospitals NHS Foundation Trust

Locations

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Sheffield Teaching Hospitals NHS Foundation Trust

Sheffield, South Yorkshire, United Kingdom

Site Status

Countries

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United Kingdom

Other Identifiers

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STH16575

Identifier Type: -

Identifier Source: org_study_id