Methods: manual development
By consolidating all the data gathered from the previous workshops, the physical activity and psychosocial intervention components were mapped (46)(47) alongside the PRISMS Taxonomy of Self-Management Support (36)(37), behaviour change theory and the Behaviour Change Techniques taxonomy (38)(48) to develop a fully manualised intervention (Table 1). The overarching theories used to inform the development of the intervention were behaviour change theory (COM-B) (39), social learning (49) and group-based learning (50). Practitioner and participant workbooks were developed as a guide and a comprehensive tool to consolidate learning. These were based on manuals from other rehabilitation trials (46)(47)(48) and circulated to the wider intervention team to incorporate feedback on content and layout.
Table 1: Intervention components, PRISMS Taxonomy of Self-Management Support, theoretical underpinnings and Behaviour Change Techniques taxonomy
Overarching category
|
Intervention component and/or delivery
|
Aims
|
PRISMS Taxonomy of Self-Management Support component
|
Theoretical Framework(s)
|
Behaviour Change Techniques taxonomy
|
Specific delivery mode
|
Online one-to-one sessions
Initial consultation and check-ins
|
To develop practitioner- participant relationship and to assess medical physical and psychosocial barriers and facilitators to physical activity participation.
|
Training/rehearsal for psychological strategies
Practical Support with adherence (behavioural)
|
Bio-Psychosocial, COM-B
|
Focus on past success
Self-talk
|
Group based sessions
|
To share experiences and learning and offer social support.
|
Social support
|
Social learning, COM-B, group-based learning
|
Feedback on behaviour
Behavioural practice/ rehearsal
|
Physical activity
|
Supervised online live group physical activity sessions
Bands and balls were provided to all participants to support these sessions
|
To guide, support and educate participants on appropriate, safe and tailored physical activity, as well as how and when to progress.
To provide guidance, practical skills and motivation to improve: Movement and Mobility
Stamina
Muscular strength
Autonomic control
Cardiorespiratory fitness
Flexibility
Agility
Co-ordination
Balance
Proprioception
|
Lifestyle advice and support
Practical Support with adherence (behavioural)
Provision of equipment
|
COM-B
Self-regulation theory
|
Instruction on how to perform a behaviour
Demonstration of the Behaviour
Exposure
Graded tasks
Body changes
Adding objects to the environment
|
On-demand library of physical activity sessions
Asynchronous online resource
Bands and balls were provided to all participants to support these sessions
|
To encourage maintenance and sustainability of physical activity behaviour external from supervised sessions.
|
Lifestyle advice and support
Practical Support with adherence (behavioural)
Provision of equipment
|
COM-B
Self-regulation theory
|
Instruction on how to perform a behaviour
Demonstration of the Behaviour
Exposure
Graded tasks
Body changes
Adding objects to the environment
|
Recumbent exercise bike at home independently
|
To provide equipment for participants to use at home
|
Provision of equipment
|
COM-B
Self-regulation theory
|
Adding objects to the environment
|
Lifestyle and behaviour change support sessions tailored to a physical activity focus
|
Expectations, motivation
|
To introduce intervention framework and allow participants to reflect on their own motivations and expectations.
|
Training/rehearsal for psychological strategies
|
Bio-Psychosocial, COM-B, Acceptance Theory
|
Information about
health consequences
Pros and cons
|
Goal setting and planning
|
To increase understanding of PoTS, impact and allow participants to set their own realistic targets and practice planning.
|
Training/rehearsal for psychological strategies
|
Bio-Psychosocial, COM-B
|
Goal setting (behaviour)
Goal setting (outcome)
Action planning
|
Fear avoidance and breaking the cycle
|
To introduce the concept and relationship between anxiety, fear and impact on daily activities including movement. To explore strategies to break this cycle such as pacing of activities.
|
Training/rehearsal for psychological strategies
|
Bio-Psychosocial, COM-B
Fear avoidance model
|
Problem solving
Behavioural practice/ Rehearsal
Framing/reframing
|
Emotional impact (Stress and mood)
|
To introduce and increase understanding of stress and unhelpful thoughts, emotional impact and effective coping strategies.
|
Training/rehearsal for psychological strategies
|
Bio-Psychosocial, COM-B
CBT principles
|
Reduce negative emotions
Information about social and environmental consequences
Monitoring of emotional consequences
|
Sustainable behaviour change and working through setbacks
|
To reflect on learning throughout the programme, progress made, future planning and enhance confidence to sustain behaviour change.
|
Training/rehearsal for psychological strategies
|
Social learning, COM-B, group-based learning
|
Review behaviour goal(s)
Comparative imagining
of future outcomes
|
Guidance provided
|
Participant Workbook
|
To give participants information related to each part of the intervention, summary pages, case studies and questions to answer to help progress through the intervention. This provides behavioural adherence support and a behaviour diary.
|
Practical Support with adherence (behavioural)
|
COM-B
|
Self-monitoring of Behaviour
Habit formation
Habit reversal
Generalisation of a target behaviour
|
Practitioner Manual
|
To offer practitioners a step-by-step guide to deliver the intervention
|
Not applicable because the Taxonomy is focused on components to support the person with the condition only.
|
COM-B
Motivational Interviewing
|
Credible source
Verbal persuasion about capability
|
Results: manual development
In addition to the original three identified PRISMS taxonomy components following the PPI co-define activities (‘lifestyle advice and support’, ‘social support’ and ‘training/rehearsal for psychological strategies’), two additional taxonomy components were included in the intervention: ‘provision of equipment’ and ‘practical Support with adherence (behavioural)’) (36)(37). It is also worth noting that as part of the feasibility trial protocol, participants could make contact if they had a question or concern arising from their participation in the intervention. This, in itself, may provide interventional benefits in relation to the ‘provision of easy access to advice or support when needed’ component, even though not officially part of the intervention.
Group sessions were designed to promote connection and are particularly important to help with social support for anyone feeling isolated or stigmatised with living with PoTS (51). Group learning and support promotes learning through shared experiences and modelling of behaviour (adapting coping strategies to enhance wellbeing). Self-efficacy and confidence can also be enhanced through observing others, following instruction or demonstration that was incorporated into the PULSE intervention.
The COM-B (39) mapped three core principles of the intervention: capability, opportunity and motivation. To enhance participants perceived capability (psychological and physical), lifestyle and behaviour change support sessions were designed to enhance understanding of PoTS and physical activity in relation to cognitions (unhelpful thinking), mood and emotions, such as fear avoidance of physical activity. The aim was to integrate physical activity sessions with the lifestyle and behaviour change support sessions to increase confidence and skills through supervised practice and over time increase levels of physical activity.
To address factors associated with opportunity, the intervention was designed to allow access to resources such as a workbook with information about the intervention structure, aims and content of all sessions, and access to equipment if needed. In addition, the lifestyle and behaviour change support sessions were designed to explore social norms, as co-creators described living with PoTS as isolating and were acutely aware of the lack of understanding from some of those around them, often including family, friends, and clinicians.
To improve motivation, the lifestyle and behaviour change support sessions included case studies and discussion topics exploring beliefs around PoTS and physical activity management strategies, values, goals, sense of self identity, and perceived ability to engage in the programme and beyond, whilst gaining awareness of current barriers and facilitators that may be preventing behaviour change such as fear, stress, and anxiety (worry about the future). The biopsychosocial influences of living with PoTS allowed us to address the physical, emotional, and cognitive factors identified in the literature and through our co-creation work. This is demonstrated in a logic model (figure 2).
Feedback from the intervention team included ensuring the integration between the physical activity, and lifestyle and behaviour change support session topics was clear by incorporating information linking the different topics, especially relating to the impact of PoTS on daily living. For the practitioner workbook, feedback was to include questions that directed the conversation with specific cues around the topic area, because each section had a limited time, and having too many generic questions could be difficult to manage during the sessions.
Methods: intervention staff training and feedback
Training sessions were held face-to-face at Coventry University and online with seven clinical exercise physiologists trained to be PULSE intervention practitioners. Training covered PoTS (clinical presentation, symptoms, and impact), physical activity assessment and prescription, motivational interviewing and communication skills. Competences required to deliver the intervention included the ability to recognise and support the management of PoTS symptoms with communication and reassurance. Post-pandemic, each intervention facilitator was given additional training online on the adapted manual and workbook.
Results: intervention staff training and feedback
Feedback from training included: 1) more practice was required to feel confident in delivering the lifestyle and behaviour change support sessions; 2) to incorporate fear avoidance early on in the programme to allow participants time to adapt their thinking, action their goals and encourage engagement with the physical activity sessions; 3) to simplify the thought diary to capture unhelpful thoughts; and 4) to add in case studies where possible to allow exploration of the topic.
Final PULSE intervention for feasibility testing
The final PULSE intervention consists of 1) an online 1:1 consultation with a PULSE practitioner; 2) 12 weeks of supervised live online group physical activity; 3) six facilitated live online group lifestyle and behaviour change support sessions; 4) on-demand library of physical activity sessions; 5) recumbent exercise bike at home; 6) weekly online 1:1 check-in; and 7) participant workbook (Figure 3).
Quality assurance
Quality assurance of delivery of the PULSE intervention will be assessed through observations by a Health Psychologist, with feedback given to each practitioner. Quality assurance will assess delivery as well as adherence to the practitioner manual, structure and topics. During the PULSE intervention training, practitioners were informed that the manual was a guide and that there was some flexibility, but the aim should be to deliver all the content and cover all the topics.