- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07315763
Group Skills Training for Body Awareness and Managing Emotions
Polyvagal Informed Group Skills Training for Body Awareness and Managing Emotions for People Living With Obesity
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jodie S Ferris
- Phone Number: 07521858668
- Email: jodie.ferris2023@live.rhul.ac.uk
Study Locations
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Surrey
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Ashford, Surrey, United Kingdom, TW15 3AA
- Ashford and St Peter's Hospital NHS Foundation Trust
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Contact:
- Alexandria Phillips, DClinPsy
- Phone Number: 01784 884620
- Email: alexandria.phillips1@nhs.net
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Baseline Phase
Participants will be randomized to a 2 or 3 week baseline phase.
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Experimental: Intervention Phase
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.
|
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.
Other Names:
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No Intervention: Follow-up Phase
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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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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.
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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.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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.
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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.
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13 weeks maximum, from day 1 of the 9-week intervention and until the last day of the 4-week follow up phase.
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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.
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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.
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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.
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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.
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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.
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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.
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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The University of Rhode Island Change Assessment (URICA)
Time Frame: To be completed once before starting the day 1 of baseline phase.
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To be completed once before starting the baseline phase.
The University of Rhode Island Change Assessment (URICA) is a questionnaire used to assess an individual's readiness to change a problem behaviour and categorises individuals into one of four stages of change: Precontemplation, Contemplation, Action, and Maintenance.
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To be completed once before starting the day 1 of baseline phase.
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Jodie F Ferris, Royal Holloway University
- Study Chair: Jodie S Vasiliou, C.Psychol., Royal Holloway University
- Study Director: Katie S Ashcroft, DClinPsy, Royal Holloway University
Publications and helpful links
General Publications
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimated)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- IRAS 356169
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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