Connecting Breath and Mind for CYP With Long COVID

NCT05705154 | Unknown

• 1 other identifier: 315063
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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 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

Keywords

Teenager; Adolescent

Outcome Measures

Primary Outcomes (1)

• Impact score of Strength and Difficulties (SDQ) questionnaire

  25 item questionnaire comprising of 5 scales of 5 items

  Through study completion, an average of 24 weeks

Secondary Outcomes (8)

• Revised Childhood Anxiety and Depression Scale (RCADS) questionnaire

  Through study completion, an average of 24 weeks

• EQ-5D-Y

  Through study completion, an average of 24 weeks

• SF-36 Quality of Life

  Through study completion, an average of 24 weeks

• 11 item Chandler Fatigue Questionnaire

  Through study completion, an average of 24 weeks

• Visual Analogue Scale (VAS) Pain scale

  Through study completion, an average of 24 weeks

Study Arms (2)

Standard treatment

ACTIVE COMPARATOR

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.

Behavioral: Psychology interventions

Intervention

EXPERIMENTAL

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.

Behavioral: Psychology interventions

Interventions

Psychology interventions BEHAVIORAL

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.

Also known as: breathing pattern retraining

Intervention; Standard treatment

Eligibility Criteria

• Age: 12 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Royal Brompton & Harefield NHS Foundation Trust: lead
• Guy's and St Thomas' NHS Foundation Trust: collaborator
• University College London Hospitals: collaborator

Study Sites (1)

The Royal Brompton Hospital part of Guys and St Thomas' NHS Foundation Trust

London, Chelsea, SW3 6NP, United Kingdom

RECRUITING

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome; Anxiety Disorders; Dyspnea

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Mental Disorders; Respiration Disorders; Signs and Symptoms, Respiratory; Signs and Symptoms

Central Study Contacts

Samatha Sonnappa, MD PhD

CONTACT

02073528121; s.sonnappa@rbht.nhs.uk

Ira Jakupovic

CONTACT

02073518109; i.jakupovic@rbht.nhs.uk

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Participants will be randomised using block randomisation into either standard intervention arm or standard intervention plus the new co-designed intervention.

Study Record Dates

• First Submitted: December 15, 2022
• First Posted: January 30, 2023
• Study Start: April 30, 2023
• Primary Completion: March 30, 2024
• Study Completion: March 30, 2024
• Last Updated: September 8, 2023

Record last verified: 2023-09

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)