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Compassion-Focused Therapy for People With Severe Obesity. (CFT)

Primary Purpose

Severe Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Compassion-focused therapy
Sponsored by
National University of Ireland, Galway, Ireland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Severe Obesity

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • Participant has a clinical diagnosis of Severe Obesity, as defined by a Body Mass Index (BMI) of 40 kg/m² or more
  • Participant is aged 18 years or older
  • Participant is not in receipt of psychological interventions at the time of randomisation to group

Exclusion Criteria:

  • Participant has insufficient English language ability to take part in the group and complete questionnaires

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    No Intervention

    Arm Label

    Compassion-focused therapy

    Treatment as Usual

    Arm 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.

    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.

    Outcomes

    Primary Outcome Measures

    Self-compassion
    The Self-Compassion Scale, Short Form (SCS-SF). This is a 12-item self-report measure, developed by Neff (2003).

    Secondary Outcome Measures

    Shame
    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).
    Self-criticism
    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.
    Submissive Behaviour
    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).
    Social Comparison
    Social Comparison Scale (SCS). This scale was developed by Allan and Gilbert (1995) to measure self-perceptions of social rank and relative social standing

    Full Information

    First Posted
    July 31, 2017
    Last Updated
    August 15, 2017
    Sponsor
    National University of Ireland, Galway, Ireland
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    1. Study Identification

    Unique Protocol Identification Number
    NCT03249441
    Brief Title
    Compassion-Focused Therapy for People With Severe Obesity.
    Acronym
    CFT
    Official Title
    Compassion-Focused Therapy for People With Severe Obesity: A Randomised Controlled Study.
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    August 2017
    Overall Recruitment Status
    Unknown status
    Study Start Date
    September 15, 2016 (Actual)
    Primary Completion Date
    May 15, 2017 (Actual)
    Study Completion Date
    September 15, 2017 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    National University of Ireland, Galway, Ireland

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    Detailed Description
    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: Does CFT significantly improve levels of self-compassion and social comparison? Hypotheses: It was hypothesised that CFT would show significant improvements in comparison to TAU on self-compassion and social comparison variables. It was hypothesised that these improvements would be maintained at 3 months follow up. Is CFT effective in reducing levels of shame, self-criticism and submissive behaviour for people who are severely obese? Hypotheses: It was hypothesised that CFT would achieve significant reductions in shame, self-criticism, and submissive behaviour variables in comparison to TAU. It was hypothesised that these changes would be maintained at 3 months follow up. Does CFT reduce emotional eating and depression? Hypotheses: It was hypothesised that CFT would show significant reductions in emotional eating and depression variables in comparison to TAU. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Severe Obesity

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    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.
    Masking
    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.
    Allocation
    Randomized
    Enrollment
    91 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Compassion-focused therapy
    Arm Type
    Experimental
    Arm 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 Title
    Treatment as Usual
    Arm Type
    No Intervention
    Arm 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(s)
    Compassion-focused therapy
    Intervention 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. __________________________________________________________________________
    Primary Outcome Measure Information:
    Title
    Self-compassion
    Description
    The Self-Compassion Scale, Short Form (SCS-SF). This is a 12-item self-report measure, developed by Neff (2003).
    Time Frame
    6 months
    Secondary Outcome Measure Information:
    Title
    Shame
    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).
    Time Frame
    6 months
    Title
    Self-criticism
    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.
    Time Frame
    6 months
    Title
    Submissive Behaviour
    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).
    Time Frame
    6 months
    Title
    Social Comparison
    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
    Time Frame
    6 months
    Other Pre-specified Outcome Measures:
    Title
    Mood
    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).
    Time Frame
    6 months
    Title
    Emotional Eating
    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.
    Time Frame
    6 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    Inclusion Criteria: Participant has a clinical diagnosis of Severe Obesity, as defined by a Body Mass Index (BMI) of 40 kg/m² or more Participant is aged 18 years or older Participant is not in receipt of psychological interventions at the time of randomisation to group Exclusion Criteria: Participant has insufficient English language ability to take part in the group and complete questionnaires
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Mary J Hynes, M.Psych.Sc
    Organizational Affiliation
    National Univeristy of Ireland, Galway
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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