Compassion-Focused Therapy for People With Severe Obesity.

Severe Obesity Clinical Trial

— CFT  

Official title:

Compassion-Focused Therapy for People With Severe Obesity: A Randomised Controlled Study.

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03249441
• Other study ID #: NUIreland
• Status: Active, not recruiting
• Phase: N/A
• First received: July 31, 2017
• Last updated: August 15, 2017
• Start date: September 15, 2016
• Est. completion date: September 15, 2017

Study information

• Verified date: August 2017
• Source: National University of Ireland, Galway, Ireland
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 91
• Est. completion date: September 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Obesity
• Obesity, Morbid
• Severe Obesity

Intervention

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. __________________________________________________________________________

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
National University of Ireland, Galway, Ireland

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Mood	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).	6 months
Other	Emotional Eating	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.	6 months
Primary	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	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).	6 months
Secondary	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.	6 months
Secondary	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).	6 months
Secondary	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	6 months