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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT06231238
Other study ID # 326529
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date March 2024
Est. completion date September 2025

Study information

Verified date January 2024
Source King's College London
Contact Trudie Chalder, PhD
Phone +44 (0)20 7848 0406
Email trudie.chalder@kcl.ac.uk
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

This randomised controlled trial aims to investigate the efficacy of a psychological intervention for long COVID (LC) / post-COVID-19 syndrome (PCS) called Balance Acceptance and Commitment Therapy (Balance ACT). The primary objective of this trial is to investigate whether Balance-ACT improves quality of life over treatment as usual (i.e., self-help leaflet) in people with PCS/LC.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 196
Est. completion date September 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility Inclusion Criteria: 1. Age 18 or older 2. LC/PCS diagnosis as defined by National Health Service (NHS) / National Institute for Health and Care Excellence (NICE) (i.e., symptoms that develop during or after an infection consistent with COVID-19, continue for more than 12 weeks and are not explained by an alternative diagnosis). A checklist will be used to ensure participants fulfil the diagnostic criteria as per the NICE guidelines 3. Ability to travel to the research site for the study assessments 4. Consent to wear a smartwatch throughout the study 5. Having registered with a General Practitioner (GP) in the United Kingdom (UK) and consent to provide their details for the study team to contact 6. Ability to provide informed consent 7. Ability to read and write English Exclusion Criteria: 1. Current diagnosis of an active major mental health disorder likely to interfere with participation 2. Unstable alcohol / drug dependency 3. Unstable complications associated with LC/PCS 4. Past hospitalisation for COVID-19 5. Current or recent participation in other treatment intervention studies (<4 weeks after completion) 6. Currently receiving psychological support or psychotherapy 7. Implanted medical devices (ie., Pacemaker/defibrillator or implanted neurostimulator/infusion device; implanted metal objects; artificial hip/knee replacement, spinal surgery; cardiac surgery requiring the placement of metal clips, valves or wires) 8. Pregnancy

Study Design


Related Conditions & MeSH terms


Intervention

Behavioral:
Balance Acceptance and Commitment Therapy
Balance-ACT is an ACT-based psychological intervention specifically designed for people with PCS/LC. Balance-ACT will use ACT techniques and mindfulness and will focus on establishing a balance psychologically and physiologically and regulating homeostasis. More specifically, Balance ACT will aim to regulate behaviours such as sleep, stress and activity, which can subsequently have an impact on homeostasis and physiology. Balance-ACT will also encourage people to live a values-based life and set goals according to their values.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
King's College London

Outcome

Type Measure Description Time frame Safety issue
Primary 36-item Short Form Health Survey (SF-36) Week 0, 14 and 20
Secondary EuroQol 5 Dimension - 5 Levels (EQ-5D-5L) Week 0, 14 and 20
Secondary Service use Week 0 and 20
Secondary Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) Week 0, 7, 14 and 20
Secondary Modified Clinical Global Impressions Scale- Improvement (CGI-I) Week 0, 14 and 20
Secondary Pittsburgh Sleep Quality Index (PSQI) Week 0, 7, 14 and 20
Secondary Modified Patient Health Questionnaire-15 (PHQ-15) Week 0, 7, 14 and 20
Secondary Montreal cognitive assessment (MoCA) Week 0, 14 and 20
Secondary Perceived Deficits Questionnaire (PDQ) Week 0, 7, 14 and 20
Secondary Patient Health Questionnaire-8 (PHQ-8) Week 0, 7, 14 and 20
Secondary Generalised Anxiety Disorder-7 (GAD-7) Week 0, 7, 14 and 20
Secondary Work and social adjustment scale (WSAS) Week 0, 14 and 20
Secondary Modified DePaul Post exertional malaise questionnaire Week 0, 7, 14 and 20
Secondary Post Traumatic Stress Disorder Checklist (PCL-5) Week 0, 14 and 20
Secondary Nijmegen Questionnaire (NQ) Week 0, 14 and 20
Secondary Dyspnoea-12 Week 0, 14 and 20
Secondary Modified Medical Research Council Dyspnea Scale (mMRC) Week 0, 14 and 20
Secondary Lung function (spirometry, Resting pulse oximetry; SpO2) Week 0, 14 and 20
Secondary Muscle strength Week 0, 14 and 20
Secondary Muscle fatigue Handgrip volitional fatigue, Quadriceps non-volitional fatigue Week 0, 14 and 20
Secondary 1 minute sit-to-stand test Week 0, 14 and 20
Secondary 4 metre gait speed Week 0, 14 and 20
Secondary Short Physical Performance Battery (SPPB) Week 0, 14 and 20
Secondary International Physical Activity Questionnaire - Short Form (IPAQ-SF) Week 0, 7, 14 and 20
Secondary Heartrate variability Week 0, 7 and 14
Secondary Cognitive and Behavioural Responses Questionnaire (CBRQ) Week 0, 7, 14 and 20
Secondary Comprehensive assessment of Acceptance and Commitment Therapy processes Week 0, 7, 14 and 20
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