Ignite Creation Date:
2024-05-06 @ 6:34 PM
Last Modification Date:
2024-10-26 @ 2:50 PM
Study NCT ID:
NCT05705154
Status:
RECRUITING
Last Update Posted:
2023-09-08
First Post:
2022-12-15
Brief Title:
Connecting Breath and Mind for CYP With Long COVID
Sponsor:
Royal Brompton Harefield NHS Foundation Trust
Organization:
Royal Brompton Harefield NHS Foundation Trust
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2023-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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 QA 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
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 QA 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
Detailed Description:
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
Improved dysfunctional breathing measured by multi-dimensional physiotherapy assessment of breathing pattern including Nijmegen questionnaire breathing pattern category SMART goal setting lung function and cardiopulmonary exercise testing and specialist physiotherapist assessment of breathing pattern quality pre- and post-intervention
At baseline and 6-monthly all CYP will complete the standard assessment questionnaires for the long COVID pan-London pathway in line with the NHSE commissioning guidance which includes the following questionnaires to assess quality of life psychological well-being and adaptive functioning
Revised Childrens Anxiety and Depression Scale RCADS questionnaire 17 pre- and post-intervention
EQ-5D-Y 25
SF-36 Quality of life 26
11-item Chalder Fatigue Questionnaire 27 and
Visual analogue pain scale
FitBit Activity monitoring including daily step counts daily distance travelled daily stairs climbed sedentary minutes low moderate and vigorous activity minutes sleep hours and wear time
Secondary research question Are co-designed virtual psychology and physiotherapy interventions acceptable and feasible to service users
Quantitative data participation attendance and dropout rates will be collected Technical issues with being able to access the intervention will be documented
Qualitative feedback will be obtained to enable development of the intervention
-The facilitators will gather live feedback towards the end of each group session using a range of approaches As part of the focus groups the CYP will review the outcome measure to get feedback if these are the things that matter to them the most Activities to explore outcomes that matter to CYP will be reviewed in the focus groups
Qualitative feedback will also be obtained after completion of all the group sessions when the investigator administers the post-intervention measures This will include measures of usefulness willingness to recommend to a friend and qualitative questions on experience of the group best parts of the group and suggestions for improvement
The investigator will also assess the impact of prior mental health problems severity of COVID infection community acquired vs hospitalised and prior functioning on intervention response
Study Design The project is a Pan-London research project recruiting patients from across London
The objectives of this two-part research project are firstly to co-design a novel holistic group intervention with children and young people with long COVID The intervention will be developed based on existing literature and interventions for psychological distress and for dysfunctional breathing in similar clinical cohorts and from focus groups with CYP with long COVID and their parents caregivers to ensure acceptability and appropriateness
The second phase of this project will be to prospectively pilot the new services to assess the efficacy acceptability and feasibility from both the service user and service providers The intervention will be piloted in a cohort of CYP with long COVID as an adjunctive intervention to treatment as usual assessing impact on well being and breathing outcomes
Phase I Co-design Method 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
Participation of CYP will include
The use of group interventions co-designed with CYP with other conditions such as diabetes chronic pain myalgic encephalomyelitischronic fatigue syndrome and medically unexplained conditions as examples to help CYP with long COVID consider some possibilities and enable them to develop their own ideas for the intervention
Responding to feedback and recruitment of CYP advisors name and responsibilities included in the role to be agreed with CYP
The use of focus groups guided by 4Pi framework and principles NSUN 2015 including openness and transparency about the process finding ways to ensure the meaningful involvement of all CYP with long COVID including those from black and minority ethnic communities LGBTQ young people and other marginalised groups to co-design and develop the intervention consider recruitment and outcome measures
The University College London Hospitals UCLH psychology team have developed a number of innovative and award-winning groups 20-24 that will be used as exemplars to help young people think what they might want to be included in the groups as well as delivery style eg vlogs and podcasts versus leaflet preferred frequency and length Parents will also be invited to attend a focus group and invited to comment on similar questions The investigators are planning to offer the groups for the CYP unaccompanied by parents
- As part of the focus groups the CYP will review the outcome measures to get feedback if these are the things that matter to them the most Activities to explore outcomes that matter to CYP will be reviewed in the focus groups
Each focus group session will be via zoom and be recorded The recording will be downloaded to a secure encrypted hospital drive The audio recording will be used to transcribe into a script Once this script is checked the video and audio recordings can be deleted
Co-design participants Service Users The investigators aim to recruit 5 to 15 young people Inclusion CYP aged between 12-18 years old who have been referred into the Pan-London Long COVID Multi-disciplinary Team MDT Clinic from its inception in 2020
Exclusion No objective evidence of SARS-CoV-2 infection eg positive PCR testing or antibodies Significant neurodevelopmental difficulties severe autism spectrum disorder ASD attention deficit hyperactivity disorder ADHD global intellectual disability andor high psychiatric risk eg 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
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
Inclusion criteria 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
Exclusion criteria No objective evidence of SARS-CoV-2 infection eg positive PCR testing or antibodies Significant neurodevelopmental difficulties severe autism spectrum disorder ASD attention deficit hyperactivity disorder ADHD global intellectual disability andor high psychiatric risk eg suicidality severe emotional or behavioral dysregulation precluding participation in group intervention PI screened during the MDT discussion and by lead researcher during telephone call for recruitment
Process Informed consent or assent will be obtained from all CYP and parental consent obtained for CYP under 16 years Parents will be given access to all resources although the intervention will be targeted towards the CYP
Each CYP will complete a screening assessment for suitability for the trial Once a potential participant has consented to take part they will have a Cardio-Pulmonary Exercise Test CPET test lung function 11 breathing pattern assessment by a respiratory physiotherapist and set up with a FitBit monitor before randomisation
Each Fitbit will be set up by the lead researcher to a new outlook account linked to the participant number The research team will be able to download data on daily step counts daily distance travelled daily stairs climbed sedentary minutes low moderate and vigorous activity minutes sleep hours and wear time The Fitbit will be synced to the patients mobile phone in clinic so they can review their daily data as well The Fitbit account will be set up with a generic date of birth weight and height so not to identify the patient
CYP will be randomised using a block randomisation approach to receive either standard treatment or standard treatment plus intervention
Standard treatment consists of virtual MDT discussion with referrer and advice signposting into local services for specific issues They are sent leaflets and info on online videos webinars and directed to standardised information on the Your COVID Recovery Website If a patient is severely affected enough to be seen face to face they are offered an interdisciplinary consultation and tailored input from PT occupational therapy OT and psychological services
Access to bite size videos and leaflets and other standardised information 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 QA session to bring any queries after watching the videos webinars
The leaflets have and online sessions have been developed by professionals from the Evelina Great Ormond Street Hospital Imperial University College London Hospital and the Whittington Additional information is being developed in online video webinar form as the services evolve The bite size videos webinars and live sessions are delivered by a clinical psychologist a dietician 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
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
Improved dysfunctional breathing measured by multi-dimensional physiotherapy assessment of breathing pattern including Nijmegen questionnaire breathing pattern category SMART goal setting lung function and cardiopulmonary exercise testing and specialist physiotherapist assessment of breathing pattern quality pre- and post-intervention
At baseline and 6-monthly all CYP will complete the standard assessment questionnaires for the long COVID pan-London pathway in line with the NHSE commissioning guidance which includes the following questionnaires to assess quality of life psychological well-being and adaptive functioning
Revised Childrens Anxiety and Depression Scale RCADS questionnaire 17 pre- and post-intervention
EQ-5D-Y 25
SF-36 Quality of life 26
11-item Chalder Fatigue Questionnaire 27 and
Visual analogue pain scale
FitBit Activity monitoring including daily step counts daily distance travelled daily stairs climbed sedentary minutes low moderate and vigorous activity minutes sleep hours and wear time
Secondary research question Are co-designed virtual psychology and physiotherapy interventions acceptable and feasible to service users
Quantitative data participation attendance and dropout rates will be collected Technical issues with being able to access the intervention will be documented
Qualitative feedback will be obtained to enable development of the intervention
-The facilitators will gather live feedback towards the end of each group session using a range of approaches As part of the focus groups the CYP will review the outcome measure to get feedback if these are the things that matter to them the most Activities to explore outcomes that matter to CYP will be reviewed in the focus groups
Qualitative feedback will also be obtained after completion of all the group sessions when the investigator administers the post-intervention measures This will include measures of usefulness willingness to recommend to a friend and qualitative questions on experience of the group best parts of the group and suggestions for improvement
The investigator will also assess the impact of prior mental health problems severity of COVID infection community acquired vs hospitalised and prior functioning on intervention response
Study Design The project is a Pan-London research project recruiting patients from across London
The objectives of this two-part research project are firstly to co-design a novel holistic group intervention with children and young people with long COVID The intervention will be developed based on existing literature and interventions for psychological distress and for dysfunctional breathing in similar clinical cohorts and from focus groups with CYP with long COVID and their parents caregivers to ensure acceptability and appropriateness
The second phase of this project will be to prospectively pilot the new services to assess the efficacy acceptability and feasibility from both the service user and service providers The intervention will be piloted in a cohort of CYP with long COVID as an adjunctive intervention to treatment as usual assessing impact on well being and breathing outcomes
Phase I Co-design Method 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
Participation of CYP will include
The use of group interventions co-designed with CYP with other conditions such as diabetes chronic pain myalgic encephalomyelitischronic fatigue syndrome and medically unexplained conditions as examples to help CYP with long COVID consider some possibilities and enable them to develop their own ideas for the intervention
Responding to feedback and recruitment of CYP advisors name and responsibilities included in the role to be agreed with CYP
The use of focus groups guided by 4Pi framework and principles NSUN 2015 including openness and transparency about the process finding ways to ensure the meaningful involvement of all CYP with long COVID including those from black and minority ethnic communities LGBTQ young people and other marginalised groups to co-design and develop the intervention consider recruitment and outcome measures
The University College London Hospitals UCLH psychology team have developed a number of innovative and award-winning groups 20-24 that will be used as exemplars to help young people think what they might want to be included in the groups as well as delivery style eg vlogs and podcasts versus leaflet preferred frequency and length Parents will also be invited to attend a focus group and invited to comment on similar questions The investigators are planning to offer the groups for the CYP unaccompanied by parents
- As part of the focus groups the CYP will review the outcome measures to get feedback if these are the things that matter to them the most Activities to explore outcomes that matter to CYP will be reviewed in the focus groups
Each focus group session will be via zoom and be recorded The recording will be downloaded to a secure encrypted hospital drive The audio recording will be used to transcribe into a script Once this script is checked the video and audio recordings can be deleted
Co-design participants Service Users The investigators aim to recruit 5 to 15 young people Inclusion CYP aged between 12-18 years old who have been referred into the Pan-London Long COVID Multi-disciplinary Team MDT Clinic from its inception in 2020
Exclusion No objective evidence of SARS-CoV-2 infection eg positive PCR testing or antibodies Significant neurodevelopmental difficulties severe autism spectrum disorder ASD attention deficit hyperactivity disorder ADHD global intellectual disability andor high psychiatric risk eg 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
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
Inclusion criteria 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
Exclusion criteria No objective evidence of SARS-CoV-2 infection eg positive PCR testing or antibodies Significant neurodevelopmental difficulties severe autism spectrum disorder ASD attention deficit hyperactivity disorder ADHD global intellectual disability andor high psychiatric risk eg suicidality severe emotional or behavioral dysregulation precluding participation in group intervention PI screened during the MDT discussion and by lead researcher during telephone call for recruitment
Process Informed consent or assent will be obtained from all CYP and parental consent obtained for CYP under 16 years Parents will be given access to all resources although the intervention will be targeted towards the CYP
Each CYP will complete a screening assessment for suitability for the trial Once a potential participant has consented to take part they will have a Cardio-Pulmonary Exercise Test CPET test lung function 11 breathing pattern assessment by a respiratory physiotherapist and set up with a FitBit monitor before randomisation
Each Fitbit will be set up by the lead researcher to a new outlook account linked to the participant number The research team will be able to download data on daily step counts daily distance travelled daily stairs climbed sedentary minutes low moderate and vigorous activity minutes sleep hours and wear time The Fitbit will be synced to the patients mobile phone in clinic so they can review their daily data as well The Fitbit account will be set up with a generic date of birth weight and height so not to identify the patient
CYP will be randomised using a block randomisation approach to receive either standard treatment or standard treatment plus intervention
Standard treatment consists of virtual MDT discussion with referrer and advice signposting into local services for specific issues They are sent leaflets and info on online videos webinars and directed to standardised information on the Your COVID Recovery Website If a patient is severely affected enough to be seen face to face they are offered an interdisciplinary consultation and tailored input from PT occupational therapy OT and psychological services
Access to bite size videos and leaflets and other standardised information 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 QA session to bring any queries after watching the videos webinars
The leaflets have and online sessions have been developed by professionals from the Evelina Great Ormond Street Hospital Imperial University College London Hospital and the Whittington Additional information is being developed in online video webinar form as the services evolve The bite size videos webinars and live sessions are delivered by a clinical psychologist a dietician 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None