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NCT05705154
Connecting Breath and Mind for CYP With Long COVID
Conditions: Post-COVID-19 Syndrome, Anxiety, Breathlessness
Sex: All
Ages: 12 Years – 18 Years
Phase: NA
Enrollment: 40
Sponsor: Royal Brompton & Harefield NHS Foundation Trust
Location: United Kingdom
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 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.InterventionBased 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-alignmentIdentifying the connections between body and mind to address anxiety and breathlessnessCoping skills for managing anxiety using principles from narrative therapy and mindfulnessOnline materials to improve self-efficacy with home practiceSocial connection with other CYP for peer support, and resource sharingActivities to help CYP reconnect with their usual activities, skills, abilities, interests, support systems
Eligibility Criteria
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 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).
Source: ClinicalTrials.gov (NCT05705154). StuddyBuddy aggregates publicly available trial information.