Body AwarenessNCT07315763
Group Skills Training for Body Awareness and Managing Emotions
A study testing Polyvagal informed skills training group in people with Body Awareness and Obesity, run by Royal Holloway University at 1 site in United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Body Awareness, Obesity, Emotional Regulation
- What is being tested?
- Polyvagal informed skills training group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 27 Jan 2026to 30 Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United Kingdom1 site
Ashford and St Peter's Hospital NHS Foundation Trust
Ashford, Surrey, TW15 3AA
Alexandria Phillips, DClinPsy, 01784 884620, alexandria.phillips1@nhs.net
About this study
Official title: Polyvagal Informed Group Skills Training for Body Awareness and Managing Emotions for People Living With Obesity
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.
Read the detailed description
This study will be a quantitative multiple baseline study using a within-subjects' single case experimental design. The study will take place over three phases; the baseline phase, the skills training intervention phase and the follow-up phase. For the baseline phase, participants will be randomly allocated a baseline period of either 14 or 21 days using an online random number generator, and the intervention (group skills training) will start immediately after the baseline period ends. 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). The intervention effect will be measured through three daily visual analogue scales and two weekly standardised measures. Outcomes will be compared at the same stages across participants. A four-week follow-up period will take place after the skills training. Participants will complete outcome measures throughout all phases. Participants will be asked to commit to a study lasting up to 16 weeks. The study will take place virtually, where questionnaires will be completed online and the group skills training will take place on an online video platform.
The participants will be patients from Ashford and St Peter's NHS Specialist Weight Management Service. They will be identified and approached by the clinical team during routine clinical contact and if the patient is interested in taking part, consent to share their details with the research team will be gained. Participants will be informed on the nature of the skills training group and provided with a video and information sheet explaining what the group will involve so they are able to decide if they wish to take part.
Participants will complete the University of Rhode Island Change Assessment (URICA) to identify their stage of change (Pre-contemplation, Contemplation, Action or Maintenance) before taking part and those in the pre-contemplation stage will not be included. Participants will be informed of this beforehand and it will be explained that this is to ensure that only those who will be best able to engage and make use of the group skills training attend the group and take part in the study, given the high level of commitment. Participants will also complete a demographics questionnaire asking them to self-report their gender, age category, ethnicity and state any comorbidities including physical health conditions, mental health conditions and neurodiversity. This information will not be used to identify the participants but will be used when considering collective group of participants and the generalisability of the findings.
In all phases, participants will complete a brief daily questionnaire in the form of a four question visual analog scale, asking participants to record the frequency they are noticing and responding to shifts in their body and engaging in an unwanted chosen behaviour, such as emotional eating. The fourth question will only be completed during the intervention and follow-up phase and asks participants to record the frequency of skills practice. Participants will also be asked to complete two short online questionnaires weekly that take up to 15 minutes to complete, the Difficulties in Emotion Regulation Scale and the Multidimensional Assessment of Interoceptive Awareness Version 2.
Participants will take part in a six-session group skills training with a Trainee Clinical Psychologist and qualified Clinical Psychologist under the supervision of the the research supervisor, a Clinical Psychologist and the treatment manual creator via video call, scheduled weekly for the first three sessions and fortnightly for the following three sessions, taking place over a nine-week period. 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. The content of the sessions will include: introduction to polyvagal theory; application of polyvagal theory to client's difficulties; mapping on the polyvagal ladder; exercises to regulate up the ladder; practicing exercises and mapping on the ladder and summarising and skills training blueprint. 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. Participants will be contacted via mobile phone or email to remind them of the group appointment and to complete daily and weekly questionnaires.
After participants have completed the group skills training, during the four-week follow-up phase, participants will complete a feedback form that will be used to assess the acceptability of the group. During this phase, participants will continue practicing learned techniques and continue to complete the daily and weekly questionnaires. At the end of the study, participants will be provided with a full debrief and signposted to further support if needed.
- Conditions
- Body Awareness, Obesity, Emotional Regulation
- Being tested
- Polyvagal informed skills training group
- Keywords
- Body awareness, Specialist Weight Management Service, Polyvagal Theory, Emotional regulation, Polyvagal theory in therapy, Single case experimental design, Skills training, Obesity
- Medical subject headings
- Obesity, Emotional Regulation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyvagal informed skills training groupBehavioural
Also called Group PVTT
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
To be completed once per day. Includes one questions asking participants about frequency of skills practice. The question is 'Over the the last 24 hours, how many times have you practiced the skills you have learnt in the group?' to rate on a scale of 0-20.
Measured: 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)
To be completed weekly. It is a 36-item a measure designed to assess difficulties in emotion regulation, providing insights into an individual's ability to understand, accept, and manage emotions effectively.
Measured: 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)
To be completed weekly. The Multidimensional Assessment of Interoceptive Awareness Version 2 (MAIA-2) is a self-report questionnaire. It has 37 items and assesses eight different dimensions of interoceptive awareness.
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jan 2026
- Study start27 Jan 2026 (estimated)
- Primary completion27 Jan 2026 (estimated)
- Study completion30 Sep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for Body AwarenessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Single group
- Model description
- All participants receive the same intervention/treatment.
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Royal Holloway University
- Sponsor type
- University, hospital or other
- Collaborators
- Ashford and St. Peter's Hospitals NHS Trust
- Responsible party
- Principal investigator, Jodie Ferris, Royal Holloway University
- Investigators
- Jodie F Ferris, Principal investigator, Royal Holloway UniversityJodie S Vasiliou, C.Psychol., Study chair, Royal Holloway UniversityKatie S Ashcroft, DClinPsy, Study director, Royal Holloway University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07315763
- Sponsor's protocol ID
- IRAS 356169
- Status last verified
- Oct 2025
- First submitted
- 18 Nov 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 30513087Porges 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.
PubMed 7652107Puhl 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.
PubMed 32053000Konttinen 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.
PubMed 30894189Fernandes 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.
PubMed 29024361Willem 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.
PubMed 32003234Vasileiou 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.
PubMed 37012653Willem 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.
PubMed 31243741
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Polyvagal Informed Group Skills Training for Body Awareness and Managing Emotions for People Living With Obesity
- ClinicalTrials.gov ID
- NCT07315763
- Acronym / sponsor ID
- IRAS 356169
- Conditions
- Body Awareness, Obesity, Emotional Regulation
- Keywords
- Body awareness, Specialist Weight Management Service, Polyvagal Theory, Emotional regulation, Polyvagal theory in therapy, Single case experimental design, Skills training, Obesity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Royal Holloway UniversityUniversity, hospital or other
- Collaborators
- Ashford and St. Peter's Hospitals NHS Trust
- Study start
- 27 Jan 2026 (estimated)
- Primary completion
- 27 Jan 2026 (estimated)
- Study completion
- 30 Sep 2026 (estimated)
- First posted
- 2 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This study will be a quantitative multiple baseline study using a within-subjects' single case experimental design. The study will take place over three phases; the baseline phase, the skills training intervention phase and the follow-up phase. For the baseline phase, participants will be randomly allocated a baseline period of either 14 or 21 days using an online random number generator, and the intervention (group skills training) will start immediately after the baseline period ends. 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). The intervention effect will be measured through three daily visual analogue scales and two weekly standardised measures. Outcomes will be compared at the same stages across participants. A four-week follow-up period will take place after the skills training. Participants will complete outcome measures throughout all phases. Participants will be asked to commit to a study lasting up to 16 weeks. The study will take place virtually, where questionnaires will be completed online and the group skills training will take place on an online video platform.
The participants will be patients from Ashford and St Peter's NHS Specialist Weight Management Service. They will be identified and approached by the clinical team during routine clinical contact and if the patient is interested in taking part, consent to share their details with the research team will be gained. Participants will be informed on the nature of the skills training group and provided with a video and information sheet explaining what the group will involve so they are able to decide if they wish to take part.
Participants will complete the University of Rhode Island Change Assessment (URICA) to identify their stage of change (Pre-contemplation, Contemplation, Action or Maintenance) before taking part and those in the pre-contemplation stage will not be included. Participants will be informed of this beforehand and it will be explained that this is to ensure that only those who will be best able to engage and make use of the group skills training attend the group and take part in the study, given the high level of commitment. Participants will also complete a demographics questionnaire asking them to self-report their gender, age category, ethnicity and state any comorbidities including physical health conditions, mental health conditions and neurodiversity. This information will not be used to identify the participants but will be used when considering collective group of participants and the generalisability of the findings.
In all phases, participants will complete a brief daily questionnaire in the form of a four question visual analog scale, asking participants to record the frequency they are noticing and responding to shifts in their body and engaging in an unwanted chosen behaviour, such as emotional eating. The fourth question will only be completed during the intervention and follow-up phase and asks participants to record the frequency of skills practice. Participants will also be asked to complete two short online questionnaires weekly that take up to 15 minutes to complete, the Difficulties in Emotion Regulation Scale and the Multidimensional Assessment of Interoceptive Awareness Version 2.
Participants will take part in a six-session group skills training with a Trainee Clinical Psychologist and qualified Clinical Psychologist under the supervision of the the research supervisor, a Clinical Psychologist and the treatment manual creator via video call, scheduled weekly for the first three sessions and fortnightly for the following three sessions, taking place over a nine-week period. 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. The content of the sessions will include: introduction to polyvagal theory; application of polyvagal theory to client's difficulties; mapping on the polyvagal ladder; exercises to regulate up the ladder; practicing exercises and mapping on the ladder and summarising and skills training blueprint. 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. Participants will be contacted via mobile phone or email to remind them of the group appointment and to complete daily and weekly questionnaires.
After participants have completed the group skills training, during the four-week follow-up phase, participants will complete a feedback form that will be used to assess the acceptability of the group. During this phase, participants will continue practicing learned techniques and continue to complete the daily and weekly questionnaires. At the end of the study, participants will be provided with a full debrief and signposted to further support if needed.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- All participants receive the same intervention/treatment.
| Arm | Type | Receives |
|---|---|---|
| Baseline Phase | No intervention | –Participants will be randomized to a 2 or 3 week baseline phase. |
| Intervention Phase | Experimental | Behavioral: Polyvagal informed skills training groupThe 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. |
| 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (4 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Polyvagal informed skills training groupAlso: Group PVTTResearch 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. | Behavioural | Intervention Phase |
Primary outcome
Body awareness and emotional regulation visual analogue scales (VAS)
Time frame: 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.
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.
3 secondary outcomes
Skills practice visual analogue scale (VAS)
Time frame: 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)
Time frame: 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)
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Background: PubMed 30513087Mehling 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.
- Background: PubMed 7652107Porges 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.
- Background: PubMed 32053000Puhl 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.
- Background: PubMed 30894189Konttinen 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.
- Background: PubMed 29024361Fernandes 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.
- Background: PubMed 32003234Willem 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.
- Background: PubMed 37012653Vasileiou 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.
- Background: PubMed 31243741Willem 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jodie F Ferris principal investigator
Royal Holloway University
Jodie S Vasiliou, C.Psychol. study chair
Royal Holloway University
Katie S Ashcroft, DClinPsy study director
Royal Holloway University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Polyvagal informed skills training group in people with Body Awareness and Obesity, run by Royal Holloway University at 1 site in United Kingdom.
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 6 inclusion and 4 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: opening soon, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jodie S Ferris (07521858668, jodie.ferris2023@live.rhul.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Body awareness and emotional regulation visual analogue scales (VAS) (time frame: 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.). 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 NCT07315763, which also lists 8 linked publications.
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 7 Jan 2026; AzTrials last refreshed its copy on 7 Nov 2026.