<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT01670331</url>
  </required_header>
  <id_info>
    <org_study_id>STH16575</org_study_id>
    <nct_id>NCT01670331</nct_id>
  </id_info>
  <brief_title>Psychological Preparation Prior to Bariatric Surgery</brief_title>
  <official_title>Psychological Preparation Prior to Bariatric Surgery: A Feasibility Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Sheffield Teaching Hospitals NHS Foundation Trust</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Sheffield Teaching Hospitals NHS Foundation Trust</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Is it feasible to perform a randomized controlled trial to assess whether or not&#xD;
      psychological preparation seminars prior to bariatric (weight loss) surgery are beneficial to&#xD;
      the investigators patients?&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a feasibility study, assessing how possible it would be to perform a randomized&#xD;
      controlled trial to see if preoperative psychological or mental health problems impacts on&#xD;
      length of stay, short and long term health outcomes, weight loss, and if preoperative&#xD;
      counseling has any effect.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2013</start_date>
  <completion_date type="Actual">February 2017</completion_date>
  <primary_completion_date type="Actual">June 2016</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>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?</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>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?</measure>
    <time_frame>12 months</time_frame>
    <description>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.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">84</enrollment>
  <condition>Obesity</condition>
  <condition>Psychological Disorders</condition>
  <arm_group>
    <arm_group_label>Psychological preparation</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Surgery as usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Patients will proceed to surgery as usual. They will complete psychological assessment forms at their follow up clinic sessions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Psychological preparation</intervention_name>
    <description>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.&#xD;
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.&#xD;
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.</description>
    <arm_group_label>Psychological preparation</arm_group_label>
    <other_name>Pre-bariatric surgery psychological programme</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  New referrals to the Sheffield Teaching Hospital Bariatric service&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-English speakers&#xD;
&#xD;
          -  Patients that are not fit for bariatric surgery&#xD;
&#xD;
          -  Patients that have already seen the bariatric psychologist&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Corinne E Owers, MB/ChB</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Adam Saradjian, DClinPsy</last_name>
    <role>Principal Investigator</role>
    <affiliation>Sheffield Teaching Hospitals NHS Foundation Trust</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Sheffield Teaching Hospitals NHS Foundation Trust</name>
      <address>
        <city>Sheffield</city>
        <state>South Yorkshire</state>
        <zip>S5 7AU</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>July 10, 2012</study_first_submitted>
  <study_first_submitted_qc>August 17, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 22, 2012</study_first_posted>
  <last_update_submitted>November 22, 2017</last_update_submitted>
  <last_update_submitted_qc>November 22, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 24, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Mental Disorders</mesh_term>
  </condition_browse>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT01670331
org study id: STH16575
nct id: NCT01670331
lead sponsor: 
has dmc: No
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?
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.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: 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
description: 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.
measure: 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
description: 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.
arm group label: Psychological preparation
arm group type: Active Comparator
description: 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
arm group label: Surgery as usual
arm group type: No Intervention
description: Patients will proceed to surgery as usual. They will complete psychological assessment forms at their follow up clinic sessions.
intervention type: Behavioral
intervention name: Psychological preparation
description: 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.
arm group label: Psychological preparation
other name: Pre-bariatric surgery psychological programme
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Corinne E Owers, MB/ChB
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
last name: Adam Saradjian, DClinPsy
role: Principal Investigator
affiliation: Sheffield Teaching Hospitals NHS Foundation Trust
facility: 
country: United Kingdom
responsible party type: Sponsor
mesh term: Mental Disorders