Group Skills Training for Body Awareness and Managing Emotions

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorRoyal Holloway University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 design

Design model

Single group

Treatments tested in this trial

  • Polyvagal informed skills training group

    Behavioral

    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.

Treatment groups

10 Participants
are divided into 3 treatment groups
Group A: Baseline PhaseNo intervention 0 interventions
Group B: Intervention PhaseExperimental treatment 1 intervention
Group C: Follow-up PhaseNo intervention 0 interventions

Trial outcomes

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.

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.

Secondary outcomes

1

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.

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.
2

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.

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.
3

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.

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.

Other outcomes

1

The University of Rhode Island Change Assessment (URICA)

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.

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

Sponsors and contacts

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Royal Holloway University

Lead sponsor

Ashford and St. Peter's Hospitals NHS Trust

Collaborator

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