NCT07315763

Brief Summary

The goal of this study is to evaluate the effectiveness of a skills training group informed by polyvagal theory, when delivered in an NHS setting, for those living with obesity. Polyvagal Theory in Therapy encourages individuals to be curious, respect how their nervous system works, and notice and respond to bodily sensations. Research shows that interoception, which is the ability to sense and understand what is happening inside the body such as recognising hunger, pain, or emotions, may be challenging for people in larger bodies. These challenges have been connected to difficulties in managing emotions which may lead to behaviours such as emotional eating. This points to the need for a therapeutic approach that helps people both notice what's happening in their bodies and trust those signals enough to be able to respond in healthy ways. This project will test whether a novel polyvagal informed skills training group can improve body awareness (interoception) and emotional regulation for people within an NHS specialist weight management service using a single case experimental design. Participants will be randomly assigned a baseline period of either 14 or 21 (phase A of the design) using computer-generated randomisation. During this phase, participants will complete outcome measures. The skills training intervention phase (phase B) will begin immediately following the individual's baseline period. The intervention is the six session group polyvagal theory-informed skills training. A four-week follow-up period will follow the skills training group, during which participants will continue to complete the same outcome measures they had used in the first two phases. This phase will help assess whether immediate treatment gains are maintained and/or whether delayed treatment gains occur. Trend analysis within this phase will show whether improvement or decline occurs post-skills training.

Trial Health

63
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
5mo left

Started Jan 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress41%
Jan 2026Sep 2026

First Submitted

Initial submission to the registry

November 18, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 2, 2026

Completed
25 days until next milestone

Study Start

First participant enrolled

January 27, 2026

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 27, 2026

Completed
8 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 30, 2026

Expected
Last Updated

January 7, 2026

Status Verified

October 1, 2025

Enrollment Period

Same day

First QC Date

November 18, 2025

Last Update Submit

January 5, 2026

Conditions

Keywords

Body awarenessSpecialist Weight Management ServicePolyvagal TheoryEmotional regulationPolyvagal theory in therapySingle case experimental designSkills trainingObesity

Outcome Measures

Primary Outcomes (1)

  • Body awareness and emotional regulation visual analogue scales (VAS)

    To be completed once per day. Includes three questions asking participants about their body awareness, taking care of body shifts and the frequency of a chosen behaviour. The questions are 'Over the last 24 hours, how many times were you able to recognise shifts in your body?' , 'Over the last 24 hours, how many times did you take care of the shifts in your body? ' and 'Over the last 24 hours, how many times have you engaged in your chosen behaviour?' to rate on a scale of 0-20.

    16 weeks maximum, from day 1 of the 2- or 3-week baseline, throughout the 9-week intervention and until last day of the 4-week follow up phase.

Secondary Outcomes (3)

  • Skills practice visual analogue scale (VAS)

    13 weeks maximum, from day 1 of the 9-week intervention and until the last day of the 4-week follow up phase.

  • Difficulties in Emotion Regulation Scale (DERS)

    16 weeks maximum, from day 1 of the 2- or 3-week baseline, throughout the 9-week intervention and until last day of the 4-week follow up phase.

  • Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2)

    16 weeks maximum, from day 1 of the 2- or 3-week baseline, throughout the 9-week intervention and until last day of the 4-week follow up phase.

Other Outcomes (1)

  • The University of Rhode Island Change Assessment (URICA)

    To be completed once before starting the day 1 of baseline phase.

Study Arms (3)

Baseline Phase

NO INTERVENTION

Participants will be randomized to a 2 or 3 week baseline phase.

Intervention Phase

EXPERIMENTAL

The skills training intervention phase will begin immediately following the individual's baseline phase. The intervention is a group polyvagal theory-informed skills training. The skills training phase is six sessions of polyvagal theory-informed skills training delivered in a group that will take place over nine weeks (three weekly sessions and three fortnightly). Each session will be two hours long. The group will focus on understanding the autonomic nervous system, respecting changes in physiology as a result of the autonomic nervous system, and learning strategies to enhance body awareness and manage emotions, such as breathing exercises. Participants will be asked to practice techniques in sessions and applied independently between sessions with the chance to feedback on the application of ideas and techniques each session.

Behavioral: Polyvagal informed skills training group

Follow-up Phase

NO INTERVENTION

After participants have completed the group skills training, there is a 4 week follow-up phase. During this phase, there is no intervention but participants will continue practicing learned techniques independently.

Interventions

Research has found a connection between obesity and challenges in managing emotions, including emotional eating (Fernandes et al., 2018; Willem et al., 2019; Konttinen et al., 2019). There is currently a lack of treatments designed to address these issues whilst also promoting a curious and accepting relationship with the body. This may be particularly important for this group who may have a history of dieting or experience internalised stigma which can create a disconnect between the person and their body, a factor that many existing approaches fail to address, even though it is known to negatively impact health (Puhl et al., 2020). This study aligns with recent shifts in health policy, which move away from focusing solely on weight loss and instead prioritise non-weight-related health outcomes (Hunger et al., 2020). This group skills training, based on Polyvagal Theory (Porges, 1995), is designed to meet these needs.

Also known as: Group PVTT
Intervention Phase

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Able to commit to the duration of the study from baseline to end of follow up period (up to 16 weeks)
  • Current service user of Specialist Weight Management Programme
  • Aged 18-65.
  • Good level of English spoken, reading and writing.
  • Identified by the University of Rhode Island Change Assessment (URICA) to be in the Contemplation, Action or Maintenance stage of change.
  • Access to device with internet connection to complete online questionnaires and with camera for online group sessions.

You may not qualify if:

  • Identified by the University of Rhode Island Change Assessment (URICA) to be in Pre-contemplation stage of change
  • Currently in psychological skills training treatment during the 16-week study period
  • History of organic brain injury or cognitive impairment
  • Clients presenting with suicidal intent

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Ashford and St Peter's Hospital NHS Foundation Trust

Ashford, Surrey, TW15 3AA, United Kingdom

Location

Related Publications (8)

  • Mehling WE, Acree M, Stewart A, Silas J, Jones A. The Multidimensional Assessment of Interoceptive Awareness, Version 2 (MAIA-2). PLoS One. 2018 Dec 4;13(12):e0208034. doi: 10.1371/journal.pone.0208034. eCollection 2018.

    PMID: 30513087BACKGROUND
  • Porges SW. Orienting in a defensive world: mammalian modifications of our evolutionary heritage. A Polyvagal Theory. Psychophysiology. 1995 Jul;32(4):301-18. doi: 10.1111/j.1469-8986.1995.tb01213.x.

    PMID: 7652107BACKGROUND
  • Puhl RM, Himmelstein MS, Pearl RL. Weight stigma as a psychosocial contributor to obesity. Am Psychol. 2020 Feb-Mar;75(2):274-289. doi: 10.1037/amp0000538.

    PMID: 32053000BACKGROUND
  • Konttinen H, van Strien T, Mannisto S, Jousilahti P, Haukkala A. Depression, emotional eating and long-term weight changes: a population-based prospective study. Int J Behav Nutr Phys Act. 2019 Mar 20;16(1):28. doi: 10.1186/s12966-019-0791-8.

    PMID: 30894189BACKGROUND
  • Fernandes J, Ferreira-Santos F, Miller K, Torres S. Emotional processing in obesity: a systematic review and exploratory meta-analysis. Obes Rev. 2018 Jan;19(1):111-120. doi: 10.1111/obr.12607. Epub 2017 Oct 10.

    PMID: 29024361BACKGROUND
  • Willem C, Nandrino JL, Doba K, Roussel M, Triquet C, Verkindt H, Pattou F, Gandolphe MC. Interoceptive reliance as a major determinant of emotional eating in adult obesity. J Health Psychol. 2021 Oct;26(12):2118-2130. doi: 10.1177/1359105320903093. Epub 2020 Jan 31.

    PMID: 32003234BACKGROUND
  • Vasileiou V, Abbott S. Emotional eating among adults with healthy weight, overweight and obesity: a systematic review and meta-analysis. J Hum Nutr Diet. 2023 Oct;36(5):1922-1930. doi: 10.1111/jhn.13176. Epub 2023 Apr 19.

    PMID: 37012653BACKGROUND
  • Willem C, Gandolphe MC, Roussel M, Verkindt H, Pattou F, Nandrino JL. Difficulties in emotion regulation and deficits in interoceptive awareness in moderate and severe obesity. Eat Weight Disord. 2019 Aug;24(4):633-644. doi: 10.1007/s40519-019-00738-0. Epub 2019 Jun 26.

    PMID: 31243741BACKGROUND

MeSH Terms

Conditions

ObesityEmotional Regulation

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and SymptomsSelf-ControlSocial BehaviorBehavior

Study Officials

  • Jodie F Ferris

    Royal Holloway University

    PRINCIPAL INVESTIGATOR
  • Jodie S Vasiliou, C.Psychol.

    Royal Holloway University

    STUDY CHAIR
  • Katie S Ashcroft, DClinPsy

    Royal Holloway University

    STUDY DIRECTOR

Central Study Contacts

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: All participants receive the same intervention/treatment.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Trainee Clinical Psychologist

Study Record Dates

First Submitted

November 18, 2025

First Posted

January 2, 2026

Study Start

January 27, 2026

Primary Completion

January 27, 2026

Study Completion (Estimated)

September 30, 2026

Last Updated

January 7, 2026

Record last verified: 2025-10

Data Sharing

IPD Sharing
Will not share

Locations