Connecting Breath and Mind: Development of an Online Holistic Treatment Programme Connecting Psychological Wellbeing and Breathing Techniques in Children and Young People With Long COVID
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Impact score of Strength and Difficulties (SDQ) questionnaire
研究概览
简要总结
Recruitment target: Phase I: Co-design of intervention: 5 to 15 CYP aged between 12-18 years of age referred to the pan-London long COVID MDT.
Phase II: Randomised pilot: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT.
Methods: Phase I: Co-design Design and setting The intervention will be co-designed with CYP following a process informed by practice-base evidence, which centres the voices and wisdom of CYP, focuses on creativity and playfulness, and systemic and narrative approaches. The process will involve: 1) Refining the intentions of key stakeholders (including ways of bringing psychological and physiological principles into the intervention); 2) Participation of CYP; 3) Creativity and playfulness and 4) Responding to feedback (see Salvo et al., 2022).
Phase II. Pilot Population: 40 patients (12-18 years) will be recruited from a potential pool of 214 patients referred to the pan-London long COVID MDT. CYP will be randomised to receive either standard treatment or standard treatment plus intervention.
Study Treatment Standard treatment consists of virtual MDT discussion with referrer and advice signposting into local services for specific issues. They are sent leaflets and information. If a patient is severely affected enough to be seen face to face, they are offered an interdisciplinary consultation, and tailored input from therapies and psychological services.
Access to bite size videos and leaflets covering the following topics: sleep, pacing, activity management, school reintegration, managing friendships, eating well and emotional wellbeing. Young people are invited to a single virtual group Q&A session to bring any queries after watching the videos.
The leaflets and online sessions have been developed by professionals from the Evelina, Great Ormond Street Hospital, Imperial, University College London Hospital, and the Whittington. The bite size videos and live sessions are delivered by a clinical psychologist, a dietitian, specialist nurse, occupational therapist, and physiotherapist. More complex or severely affected patients will receive one to one treatment with members of the MDT as required.
Intervention
Based on clinical expertise and theory, it is anticipated the following elements may be included in the intervention.:
- Progressive breathing pattern retraining, including education, self-observation, relaxation, body scanning, postural re-alignment
- Identifying the connections between body and mind to address anxiety and breathlessness
- Coping skills for managing anxiety using principles from narrative therapy and mindfulness
- Online materials to improve self-efficacy with home practice
- Social connection with other CYP for peer support, and resource sharing
- Activities to help CYP reconnect with their usual activities, skills, abilities, interests, support systems
详细描述
Hypotheses: CYP with a diagnosis of Long COVID who complete the intervention in addition to standard treatment will show a greater improvement in psychological wellbeing and demonstrate fewer functional limitations of excessive breathlessness after completing a holistic modular psychological and respiratory physiotherapy (PT) intervention compared to current standard treatment alone.
Primary objective Impact score of Strength and Difficulties (SDQ) questionnaire (included in ISARIC form - standard care assessment).
-RCADS questionnaire (17), pre- and post-intervention.
Secondary Objectives
To further answer the Ho the following measures will be taken:
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 12 Years 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All patients aged 12-18 years referred to the pan-London long COVID MDT with English of a standard adequate to participate in a group intervention.
排除标准
- •No objective evidence of SARS-CoV-2 infection e.g., positive PCR testing or antibodies. Significant neurodevelopmental difficulties (severe autism spectrum disorder (ASD), attention deficit hyperactivity disorder (ADHD), global intellectual disability) and/or high psychiatric risk e.g., suicidality, severe emotional or behavioural dysregulation precluding participation in group intervention (PI screened during the MDT discussion and by lead researcher during telephone call for recruitment).
研究组 & 干预措施
Standard treatment
Standard treatment consists of virtual MDT discussion with referrer and advice signposting into local services for specific issues. If a patient is severely affected enough to be seen face to face, they are offered an interdisciplinary consultation, and tailored input from PT OT and psychological services.
Access to standardised information covering the following topics: sleep, pacing, activity management, school reintegration, managing friendships, eating well and emotional wellbeing.
More complex or severely affected patients will receive one to one treatment with members of the MDT as required.
干预措施: Psychology interventions (Behavioral)
Intervention
As above standard intervention plus the new co-designed intervention.
Based on clinical expertise and theory, it is anticipated the following elements may be included in the intervention:
- Progressive breathing pattern retraining, including education, self-observation, relaxation, body scanning, postural re-alignment
- Identifying the connections between body and mind to address anxiety and breathlessness
- Coping skills for managing anxiety using principles from narrative therapy and mindfulness
- Online materials to improve self-efficacy with home practice
- Social connection with other CYP for peer support, and resource sharing
- Activities to help CYP reconnect with their usual activities, skills, abilities, interests, support systems.
干预措施: Psychology interventions (Behavioral)
结局指标
主要结局
Impact score of Strength and Difficulties (SDQ) questionnaire
时间窗: Through study completion, an average of 24 weeks
25 item questionnaire comprising of 5 scales of 5 items
次要结局
- Visual Analogue Scale (VAS) Pain scale(Through study completion, an average of 24 weeks)
- Physiotherapy assessment of dysfunctional breathing(Through study completion, an average of 24 weeks)
- Qualitative feedback(Through study completion, an average of 24 weeks)
- EQ-5D-Y(Through study completion, an average of 24 weeks)
- 11 item Chandler Fatigue Questionnaire(Through study completion, an average of 24 weeks)
- FitBit Activity monitoring(Through study completion, an average of 24 weeks)
- Revised Childhood Anxiety and Depression Scale (RCADS) questionnaire(Through study completion, an average of 24 weeks)
- SF-36 Quality of Life(Through study completion, an average of 24 weeks)