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Severe ObesityCFTNCT03249441

Compassion-Focused Therapy for People With Severe Obesity.

A study testing Compassion-focused therapy in people with Severe Obesity, run by National University of Ireland, Galway, Ireland.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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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… Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
Conditions the study is for
Severe Obesity
What is being tested?
Compassion-focused therapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
91 participants
Where
No sites listed yet
Study dates
15 Sep 2016to 15 Sep 2017
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

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

About this study

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

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.

Read the 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:
  2. It was hypothesised that CFT would show significant improvements in comparison to TAU on self-compassion and social comparison variables.
  3. It was hypothesised that these improvements would be maintained at 3 months follow up.
  4. Is CFT effective in reducing levels of shame, self-criticism and submissive behaviour for people who are severely obese? Hypotheses:
  5. It was hypothesised that CFT would achieve significant reductions in shame, self-criticism, and submissive behaviour variables in comparison to TAU.
  6. It was hypothesised that these changes would be maintained at 3 months follow up.
  7. 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.

Conditions
Severe Obesity
Being tested
Compassion-focused therapy
Medical subject headings
Obesity, Morbid

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compassion-focused therapyBehavioural

    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 groups in NCT03249441
Study groupRoleWhat they receive
Compassion-focused therapyExperimentalCompassion-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.
Receives: Behavioral: Compassion-focused therapy
Treatment as UsualNo interventionTreatment 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.

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Self-compassion

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

    Measured: 6 months

Secondary outcomes (4)

  1. 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).

    Measured: 6 months

  2. 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.

    Measured: 6 months

  3. 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).

    Measured: 6 months

  4. 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

    Measured: 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted15 Aug 2017
  2. Study start15 Sep 2016
  3. Primary completion15 May 2017
  4. Study completion15 Sep 2017 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
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 blind
Who is masked
Outcomes assessor
Enrolment
91 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03249441
Sponsor's protocol ID
NUIreland
Acronym
CFT
Status last verified
Aug 2017
First submitted
31 Jul 2017
Last updated
18 Aug 2017
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Hynes M, Finucane FM, Collins C, O'Brien T, McAnena O, O'Shea G, Pilch M, McGuire BE. Compassion-focused group therapy improves depression, emotional eating, self-criticism and shame in people living with severe obesity: A single-centre, examiner-blind randomized controlled trial. PLoS One. 2026 Mar 25;21(3):e0342744. doi: 10.1371/journal.pone.0342744. eCollection 2026.

    PubMed 41880241

Questions about this trial

What is this clinical trial studying?

A study testing Compassion-focused therapy in people with Severe Obesity, run by National University of Ireland, Galway, Ireland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 18 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Self-compassion (time frame: 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03249441, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2017.

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