Compassion-Focused Therapy for People With Severe Obesity.

NCT03249441 | Unknown

• 1 other identifier: NUIreland
• Study Type: interventional
• Target: 91
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Severe Obesity

Outcome Measures

Primary Outcomes (1)

• Self-compassion

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

  6 months

Secondary Outcomes (4)

• Shame

  6 months

• Self-criticism

  6 months

• Submissive Behaviour

  6 months

• Social Comparison

  6 months

Other Outcomes (2)

• Mood

  6 months

• Emotional Eating

  6 months

Study Arms (2)

Compassion-focused therapy

EXPERIMENTAL

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.

Behavioral: Compassion-focused therapy

Treatment as Usual

NO INTERVENTION

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.

Interventions

Compassion-focused therapy BEHAVIORAL

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. \_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_\_

Compassion-focused therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• National University of Ireland, Galway, Ireland: lead

MeSH Terms

Conditions

Obesity, Morbid

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Mary J Hynes, M.Psych.Sc

  National Univeristy of Ireland, Galway

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Mary Hynes, Senior Clinical Psychologist

Model Details: 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.

Study Record Dates

• First Submitted: July 31, 2017
• First Posted: August 15, 2017
• Study Start: September 15, 2016
• Primary Completion: May 15, 2017
• Study Completion: September 15, 2017
• Last Updated: August 18, 2017

Record last verified: 2017-08

Data Sharing

• IPD Sharing: Will not share