Connecting Breath and Mind for CYP With Long COVID

NCT05705154 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-09-08

No results posted yet for this study

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.

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

Conditions

  • Post-COVID-19 Syndrome
  • Anxiety
  • Breathlessness

Interventions

BEHAVIORAL

Psychology interventions

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.

Sponsors & Collaborators

  • Guy's and St Thomas' NHS Foundation Trust

    collaborator OTHER
  • University College London Hospitals

    collaborator OTHER
  • Royal Brompton & Harefield NHS Foundation Trust

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
12 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-04-30
Primary Completion
2024-03-30
Completion
2024-03-30

Countries

  • United Kingdom

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05705154 on ClinicalTrials.gov