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

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ClinicalTrials.gov Identifier: NCT03249441
Recruitment Status : Unknown
Verified August 2017 by Mary Hynes, National University of Ireland, Galway, Ireland.
Recruitment status was:  Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : August 18, 2017
Sponsor:
Information provided by (Responsible Party):
Mary Hynes, National University of Ireland, Galway, Ireland

Tracking Information
First Submitted Date  ICMJE July 31, 2017
First Posted Date  ICMJE August 15, 2017
Last Update Posted Date August 18, 2017
Actual Study Start Date  ICMJE September 15, 2016
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 12, 2017)
Self-compassion [ Time Frame: 6 months ]
The Self-Compassion Scale, Short Form (SCS-SF). This is a 12-item self-report measure, developed by Neff (2003).
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03249441 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: August 12, 2017)
  • Shame [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    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 [ Time Frame: 6 months ]
    Social Comparison Scale (SCS). This scale was developed by Allan and Gilbert (1995) to measure self-perceptions of social rank and relative social standing
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: August 12, 2017)
  • Mood [ Time Frame: 6 months ]
    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).
  • Emotional Eating [ Time Frame: 6 months ]
    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.
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE Compassion-Focused Therapy for People With Severe Obesity.
Official Title  ICMJE Compassion-Focused Therapy for People With Severe Obesity: A Randomised Controlled Study.
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:

  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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE 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.
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.
Primary Purpose: Treatment
Condition  ICMJE Severe Obesity
Intervention  ICMJE Behavioral: Compassion-focused therapy

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.

__________________________________________________________________________

Study Arms  ICMJE
  • Experimental: Compassion-focused therapy
    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.
    Intervention: Behavioral: Compassion-focused therapy
  • No Intervention: 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.
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Actual Enrollment  ICMJE
 (submitted: August 12, 2017)
91
Original Actual Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE September 15, 2017
Actual Primary Completion Date May 15, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Not Provided
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03249441
Other Study ID Numbers  ICMJE NUIreland
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mary Hynes, National University of Ireland, Galway, Ireland
Study Sponsor  ICMJE National University of Ireland, Galway, Ireland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Mary J Hynes, M.Psych.Sc National Univeristy of Ireland, Galway
PRS Account National University of Ireland, Galway, Ireland
Verification Date August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP