<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/NCT03249441</url>
  </required_header>
  <id_info>
    <org_study_id>NUIreland</org_study_id>
    <nct_id>NCT03249441</nct_id>
  </id_info>
  <brief_title>Compassion-Focused Therapy for People With Severe Obesity.</brief_title>
  <acronym>CFT</acronym>
  <official_title>Compassion-Focused Therapy for People With Severe Obesity: A Randomised Controlled Study.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>National University of Ireland, Galway, Ireland</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>National University of Ireland, Galway, Ireland</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study aims to explore the effectiveness of a group psychotherapy intervention using&#xD;
      Compassion-Focused Therapy (CFT) in adults with severe obesity. In particular, it aims to&#xD;
      evaluate the principle that CFT can be used to reduce levels of shame and self-criticism in&#xD;
      adults with severe obesity&#xD;
&#xD;
      OBJECTIVES:&#xD;
&#xD;
      The objective of the current study is to assess and compare a CFT group intervention to&#xD;
      Treatment as Usual (TAU) with regard to psychological functioning, specifically&#xD;
      self-compassion, shame, self-criticism, emotional eating and mood.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Compassion-focused therapy (CFT) was specifically designed for people with high levels of&#xD;
      shame, self-criticism and self-directed hostility by helping people to cultivate affiliative&#xD;
      emotions and compassion.The current research aims to explore changes in levels of&#xD;
      self-criticism, shame, submissive behaviour, and self-comparison in a severely obese&#xD;
      population who are awaiting bariatric surgery. As depression symptoms and levels of emotional&#xD;
      eating can interfere with bariatric surgery success, these constructs are included as&#xD;
      secondary outcomes for research.&#xD;
&#xD;
      Research questions&#xD;
&#xD;
      The research was guided by the following research questions and hypotheses:&#xD;
&#xD;
        1. Does CFT significantly improve levels of self-compassion and social comparison?&#xD;
&#xD;
           Hypotheses:&#xD;
&#xD;
             1. It was hypothesised that CFT would show significant improvements in comparison to&#xD;
                TAU on self-compassion and social comparison variables.&#xD;
&#xD;
             2. It was hypothesised that these improvements would be maintained at 3 months follow&#xD;
                up.&#xD;
&#xD;
        2. Is CFT effective in reducing levels of shame, self-criticism and submissive behaviour&#xD;
           for people who are severely obese?&#xD;
&#xD;
           Hypotheses:&#xD;
&#xD;
             1. It was hypothesised that CFT would achieve significant reductions in shame,&#xD;
                self-criticism, and submissive behaviour variables in comparison to TAU.&#xD;
&#xD;
             2. It was hypothesised that these changes would be maintained at 3 months follow up.&#xD;
&#xD;
        3. Does CFT reduce emotional eating and depression?&#xD;
&#xD;
      Hypotheses:&#xD;
&#xD;
        1. It was hypothesised that CFT would show significant reductions in emotional eating and&#xD;
           depression variables in comparison to TAU.&#xD;
&#xD;
        2. It was hypothesised that these reductions would be maintained at 3 months follow up.&#xD;
&#xD;
      This study will use a prospective, randomised control design using quantitative methods to&#xD;
      investigate the effectiveness of CFT, using various measures pre-and post-therapy and at&#xD;
      3-month follow-up.&#xD;
&#xD;
      91 individuals with severe obesity will be randomly assigned to one of two treatment groups&#xD;
&#xD;
      - Compassion-Focused Therapy (CFT) plus treatment as usual or Treatment as Usual alone (TAU).&#xD;
&#xD;
      Individuals assigned to CFT will be introduced to the CFT model taught the main&#xD;
      compassion-focused exercises in a group setting. Self-report measures will be administered&#xD;
      prior to the commencement of the CFT group and TAU group, and during the final groups and 3&#xD;
      months follow up. To reduce the 'demand' effect, scales will be administered by an Assistant&#xD;
      Psychologist who is not involved in delivering the therapy.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">September 15, 2016</start_date>
  <completion_date type="Anticipated">September 15, 2017</completion_date>
  <primary_completion_date type="Actual">May 15, 2017</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>
    <intervention_model_description>This study utilised a randomised controlled trial (RCT) research design to investigate the efficacy of a group based CFT intervention programme. Participants were randomly allocated to one of the two groups, CFT plus Treatment as Usual (CFT) or Treatment As Usual (TAU), and psychological measures were administered at three time points (pre-intervention, post-intervention and follow-up assessment at three months follow up). The primary outcomes included self-compassion, shame and self-criticism. Emotional eating and depressive symptoms were assessed as secondary outcomes.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Clients are randomly assigned to one of two groups, Treatment as Usual (TAU) or Compassion-focused therapy plus Treatment as Usual (CFT). The outcomes assessor is blind to which of the two groups participants are assigned to.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Self-compassion</measure>
    <time_frame>6 months</time_frame>
    <description>The Self-Compassion Scale, Short Form (SCS-SF). This is a 12-item self-report measure, developed by Neff (2003).</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Shame</measure>
    <time_frame>6 months</time_frame>
    <description>Shame (the Other as Shamer Scale;OAS) The OAS is an 18- item scale developed by Goss, Gilbert, and Allan (1994).Participants respond to statements such as 'I think that other people look down on me' on a five-point Likert scale according to the frequency with which they make certain evaluations about how others judge them (0 = never, to 5 = almost always).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Self-criticism</measure>
    <time_frame>6 months</time_frame>
    <description>The Forms of the Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS). This scale was developed by Gilbert, Clark, Hempel, Miles, and Irons (2004). It was developed to measure self-criticism and the ability to self-reassure.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Submissive Behaviour</measure>
    <time_frame>6 months</time_frame>
    <description>Submissive Behaviour Scale (SBS). This scale was originally developed from the work of Buss and Craik (1986). The most highly agreed upon items were chosen to construct the Submissive Behaviour Scale (Allan &amp; Gilbert, 1997).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Social Comparison</measure>
    <time_frame>6 months</time_frame>
    <description>Social Comparison Scale (SCS). This scale was developed by Allan and Gilbert (1995) to measure self-perceptions of social rank and relative social standing</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Mood</measure>
    <time_frame>6 months</time_frame>
    <description>Beck Depression Inventory-II (BDII; Beck, Steer, &amp; Brown, 1996). The BDI-II is a widely used, 21-item self-report measure of depressive symptomatology which requires participants to respond to statements describing symptoms of depression on a scale rated 0 (never) to 3 (always).</description>
  </other_outcome>
  <other_outcome>
    <measure>Emotional Eating</measure>
    <time_frame>6 months</time_frame>
    <description>The Emotional Eating Scale (EES). This scale measures the use of eating to cope with negative mood. Responders are asked to rate the strength of their urge to eat (in one of five categories ranging from 'no urge to eat' to 'overwhelming urge to eat') in relation to 25 different emotions.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">91</enrollment>
  <condition>Severe Obesity</condition>
  <arm_group>
    <arm_group_label>Compassion-focused therapy</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Compassion-Focused Therapy (CFT) Participants were taught the main compassion-focused exercises as outlined in 'The Compassion-Mind Guide to Ending Overeating: Using Compassion-Focused Therapy to overcome Bingeing and Disordered Eating' manual (Goss, 2011) over a ten session period (weekly for 2 hours), offered over a 3 month period. Self-criticism and shame were key foci across sessions. Participants in the CFT arm also received Treatment as Usual.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Treatment as Usual</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Treatment As Usual Treatment as usual was based in the Diabetes, Endocrinology and Metabolism Clinic in Galway University Hospital. The Weight Management Service provides assessment by a multi-disciplinary team of endocrinologists, dieticians, nurse specialists and clinical psychologists. Dietary advice is given by a specialist dietician regarding weight management, assessment by the Consultant Endocrinologist with possible medication for management of diabetes and weight, and participation in a healthy lifestyle education program.</description>
  </arm_group>
  <intervention>
    <intervention_type>Behavioral</intervention_type>
    <intervention_name>Compassion-focused therapy</intervention_name>
    <description>Session-by-session summary of CFT:&#xD;
Week 1: Understanding your relationship with food Week 2: Making sense of overeating Week 3: The Compassionate Mind/ Preparing your mind for compassion Week 4: Developing the skill of self-compassion Week 5: Why we overeat - a Compassionate approach Week 6: Understanding your current eating pattern Week 7: Motivating yourself to change Week 8: Determining what your body needs Week 9: Towards a new way of eating Week 10: Compassionate letter writing and developing a compassionate focus on eating.&#xD;
__________________________________________________________________________</description>
    <arm_group_label>Compassion-focused therapy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Participant has a clinical diagnosis of Severe Obesity, as defined by a Body Mass&#xD;
             Index (BMI) of 40 kg/m² or more&#xD;
&#xD;
          -  Participant is aged 18 years or older&#xD;
&#xD;
          -  Participant is not in receipt of psychological interventions at the time of&#xD;
             randomisation to group&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participant has insufficient English language ability to take part in the group and&#xD;
             complete questionnaires&#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>Mary J Hynes, M.Psych.Sc</last_name>
    <role>Principal Investigator</role>
    <affiliation>National Univeristy of Ireland, Galway</affiliation>
  </overall_official>
  <verification_date>August 2017</verification_date>
  <study_first_submitted>July 31, 2017</study_first_submitted>
  <study_first_submitted_qc>August 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 15, 2017</study_first_posted>
  <last_update_submitted>August 15, 2017</last_update_submitted>
  <last_update_submitted_qc>August 15, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">August 18, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>National University of Ireland, Galway, Ireland</investigator_affiliation>
    <investigator_full_name>Mary Hynes</investigator_full_name>
    <investigator_title>Mary Hynes, Senior Clinical Psychologist</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Obesity</mesh_term>
    <mesh_term>Obesity, Morbid</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT03249441
org study id: NUIreland
nct id: NCT03249441
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study aims to explore the effectiveness of a group psychotherapy intervention using
      Compassion-Focused Therapy (CFT) in adults with severe obesity. In particular, it aims to
      evaluate the principle that CFT can be used to reduce levels of shame and self-criticism in
      adults with severe obesity

      OBJECTIVES:

      The objective of the current study is to assess and compare a CFT group intervention to
      Treatment as Usual (TAU) with regard to psychological functioning, specifically
      self-compassion, shame, self-criticism, emotional eating and mood.
Compassion-focused therapy (CFT) was specifically designed for people with high levels of
      shame, self-criticism and self-directed hostility by helping people to cultivate affiliative
      emotions and compassion.The current research aims to explore changes in levels of
      self-criticism, shame, submissive behaviour, and self-comparison in a severely obese
      population who are awaiting bariatric surgery. As depression symptoms and levels of emotional
      eating can interfere with bariatric surgery success, these constructs are included as
      secondary outcomes for research.

      Research questions

      The research was guided by the following research questions and hypotheses:

        1. Does CFT significantly improve levels of self-compassion and social comparison?

           Hypotheses:

             1. It was hypothesised that CFT would show significant improvements in comparison to
                TAU on self-compassion and social comparison variables.

             2. It was hypothesised that these improvements would be maintained at 3 months follow
                up.

        2. Is CFT effective in reducing levels of shame, self-criticism and submissive behaviour
           for people who are severely obese?

           Hypotheses:

             1. It was hypothesised that CFT would achieve significant reductions in shame,
                self-criticism, and submissive behaviour variables in comparison to TAU.

             2. It was hypothesised that these changes would be maintained at 3 months follow up.

        3. Does CFT reduce emotional eating and depression?

      Hypotheses:

        1. It was hypothesised that CFT would show significant reductions in emotional eating and
           depression variables in comparison to TAU.

        2. It was hypothesised that these reductions would be maintained at 3 months follow up.

      This study will use a prospective, randomised control design using quantitative methods to
      investigate the effectiveness of CFT, using various measures pre-and post-therapy and at
      3-month follow-up.

      91 individuals with severe obesity will be randomly assigned to one of two treatment groups

      - Compassion-Focused Therapy (CFT) plus treatment as usual or Treatment as Usual alone (TAU).

      Individuals assigned to CFT will be introduced to the CFT model taught the main
      compassion-focused exercises in a group setting. Self-report measures will be administered
      prior to the commencement of the CFT group and TAU group, and during the final groups and 3
      months follow up. To reduce the 'demand' effect, scales will be administered by an Assistant
      Psychologist who is not involved in delivering the therapy.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: This study utilised a randomised controlled trial (RCT) research design to investigate the efficacy of a group based CFT intervention programme. Participants were randomly allocated to one of the two groups, CFT plus Treatment as Usual (CFT) or Treatment As Usual (TAU), and psychological measures were administered at three time points (pre-intervention, post-intervention and follow-up assessment at three months follow up). The primary outcomes included self-compassion, shame and self-criticism. Emotional eating and depressive symptoms were assessed as secondary outcomes.
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Clients are randomly assigned to one of two groups, Treatment as Usual (TAU) or Compassion-focused therapy plus Treatment as Usual (CFT). The outcomes assessor is blind to which of the two groups participants are assigned to.
measure: Self-compassion
time frame: 6 months
description: The Self-Compassion Scale, Short Form (SCS-SF). This is a 12-item self-report measure, developed by Neff (2003).
measure: Shame
time frame: 6 months
description: Shame (the Other as Shamer Scale;OAS) The OAS is an 18- item scale developed by Goss, Gilbert, and Allan (1994).Participants respond to statements such as 'I think that other people look down on me' on a five-point Likert scale according to the frequency with which they make certain evaluations about how others judge them (0 = never, to 5 = almost always).
measure: Self-criticism
time frame: 6 months
description: The Forms of the Self-Criticising/Attacking and Self-Reassuring Scale (FSCRS). This scale was developed by Gilbert, Clark, Hempel, Miles, and Irons (2004). It was developed to measure self-criticism and the ability to self-reassure.
measure: Submissive Behaviour
time frame: 6 months
description: Submissive Behaviour Scale (SBS). This scale was originally developed from the work of Buss and Craik (1986). The most highly agreed upon items were chosen to construct the Submissive Behaviour Scale (Allan & Gilbert, 1997).
measure: Social Comparison
time frame: 6 months
description: Social Comparison Scale (SCS). This scale was developed by Allan and Gilbert (1995) to measure self-perceptions of social rank and relative social standing
measure: Mood
time frame: 6 months
description: Beck Depression Inventory-II (BDII; Beck, Steer, & Brown, 1996). The BDI-II is a widely used, 21-item self-report measure of depressive symptomatology which requires participants to respond to statements describing symptoms of depression on a scale rated 0 (never) to 3 (always).
measure: Emotional Eating
time frame: 6 months
description: The Emotional Eating Scale (EES). This scale measures the use of eating to cope with negative mood. Responders are asked to rate the strength of their urge to eat (in one of five categories ranging from 'no urge to eat' to 'overwhelming urge to eat') in relation to 25 different emotions.
arm group label: Compassion-focused therapy
arm group type: Experimental
description: Compassion-Focused Therapy (CFT) Participants were taught the main compassion-focused exercises as outlined in 'The Compassion-Mind Guide to Ending Overeating: Using Compassion-Focused Therapy to overcome Bingeing and Disordered Eating' manual (Goss, 2011) over a ten session period (weekly for 2 hours), offered over a 3 month period. Self-criticism and shame were key foci across sessions. Participants in the CFT arm also received Treatment as Usual.
arm group label: Treatment as Usual
arm group type: No Intervention
description: Treatment As Usual Treatment as usual was based in the Diabetes, Endocrinology and Metabolism Clinic in Galway University Hospital. The Weight Management Service provides assessment by a multi-disciplinary team of endocrinologists, dieticians, nurse specialists and clinical psychologists. Dietary advice is given by a specialist dietician regarding weight management, assessment by the Consultant Endocrinologist with possible medication for management of diabetes and weight, and participation in a healthy lifestyle education program.
intervention type: Behavioral
intervention name: Compassion-focused therapy
description: Session-by-session summary of CFT:
Week 1: Understanding your relationship with food Week 2: Making sense of overeating Week 3: The Compassionate Mind/ Preparing your mind for compassion Week 4: Developing the skill of self-compassion Week 5: Why we overeat - a Compassionate approach Week 6: Understanding your current eating pattern Week 7: Motivating yourself to change Week 8: Determining what your body needs Week 9: Towards a new way of eating Week 10: Compassionate letter writing and developing a compassionate focus on eating.
__________________________________________________________________________
arm group label: Compassion-focused therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Mary J Hynes, M.Psych.Sc
role: Principal Investigator
affiliation: National Univeristy of Ireland, Galway
responsible party type: Principal Investigator
investigator affiliation: National University of Ireland, Galway, Ireland
investigator full name: Mary Hynes
investigator title: Mary Hynes, Senior Clinical Psychologist
mesh term: Obesity
mesh term: Obesity, Morbid
sharing ipd: No