Polyvagal Informed Group Skills Training for Body Awareness and Managing Emotions for People Living With Obesity
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
- 试验地点
- 1
- 主要终点
- Body awareness and emotional regulation visual analogue scales (VAS)
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
- •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.
排除标准
- •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
研究组 & 干预措施
Baseline Phase
Participants will be randomized to a 2 or 3 week baseline phase.
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.
干预措施: Polyvagal informed skills training group (Behavioral)
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.
结局指标
主要结局
Body awareness and emotional regulation visual analogue scales (VAS)
时间窗: 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.
次要结局
- 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.)
研究者
Jodie Ferris
Trainee Clinical Psychologist
Royal Holloway University