Clinical trial NCT03249441: Compassion-Focused Therapy for People With Severe Obesity.
Official title: Compassion-Focused Therapy for People With Severe Obesity: A Randomised Controlled Study.
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Severe Obesity
Lead sponsor: National University of Ireland, Galway, Ireland
Sponsor class: OTHER
First posted: 2017-08-15
Enrollment: 91
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
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

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.

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

Primary outcomes:
measure: Self-compassion
timeFrame: 6 months
Secondary outcomes:
measure: Shame
timeFrame: 6 months
measure: Self-criticism
timeFrame: 6 months
measure: Submissive Behaviour
timeFrame: 6 months
measure: Social Comparison
timeFrame: 6 months
Other outcomes:
measure: Mood
timeFrame: 6 months
measure: Emotional Eating
timeFrame: 6 months
Locations:
Study officials:
affiliation: National Univeristy of Ireland, Galway
name: Mary J Hynes, M.Psych.Sc
role: PRINCIPAL_INVESTIGATOR
References: