Long COVID, Post-COVID-19 Syndrome
Conditions
Brief 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.
Interventions
BEHAVIORALBalance 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.
Sponsors
King's College London
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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. Having registered with a General Practitioner (GP) in the United Kingdom (UK) and consent to provide their details for the study team to contact 5. Ability to provide informed consent 6. 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. Pregnancy
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14 | Week 14 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Lung function (spirometry, Resting pulse oximetry; SpO2) | Week 0 and 14 | — |
| Muscle strength | Week 0, 7, 14 and 20 | Handgrip muscle strength: A handgrip dynamometer will be used to measure grip strength. The dynamometer will be placed in the participant's hand and the participant will be instructed to squeeze as hard as possible. |
| Muscle fatigue | Week 0 and 14 | 1. Handgrip volitional fatigue: A digital grip force transducer will be used to assess volitional handgrip fatigue. 2. Quadriceps non-volitional fatigue: Quadriceps muscle endurance will be assessed non-volitionally using transcutaneous electrical stimulation. |
| 1 minute sit-to-stand test | Week 0 and 14 | Participants will also be shown the Borg Rating of Perceived Exertion Scale and asked to rate their perceived breathlessness and leg fatigue prior to the start of the test, immediately after completion of the test, and following one minute of recovery. |
| 4 metre gait speed | Week 0 and 14 | — |
| Short Physical Performance Battery (SPPB) | Week 0 and 14 | — |
| International Physical Activity Questionnaire - Short Form (IPAQ-SF) | Week 0, 7, 14 and 20 | — |
| Heartrate variability | Week 0 and 14 | via electrocardiogram (ECG) |
| Average Heart-rate | Week 0 and 14 | Average Heart-rate will be assessed from 5 minutes of a 10-minute resting 3 lead electrocardiogram (ECG). These short-term recordings provide a non-invasive measure of autonomic nervous system function. |
| Cognitive and Behavioural Responses Questionnaire (CBRQ) | Week 0, 7, 14 and 20 | — |
| Comprehensive assessment of Acceptance and Commitment Therapy processes | Week 0, 7, 14 and 20 | — |
| Quadricep Muscle Strength | Week 0 and 14 | Volitional Quadriceps MVC and assessment of quadriceps volitional activation by twitch interpolation using electrical stimulation. |
| Post COVID Syndrome Recovery (Single Item) | Week 7, 14 and 20 | A self-reported single item questionnaire "Do you consider yourself recovered from long COVID?" |
| Treatment Satisfaction Questionnaire | Week 14 | — |
| Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 20 | Week 0, 7, and 20 | — |
| Mental Component Summary (MCS) of the 36-item Short Form Health Survey (SF-36) | Week 0, 7, 14 and 20 | — |
| EuroQol 5 Dimension - 5 Levels (EQ-5D-5L) | Week 0, 14 and 20 | — |
| Adult Service Use Schedule | Week 0 and 20 | — |
| Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F) | Week 0, 7, 14 and 20 | — |
| Modified Clinical Global Impressions Scale- Improvement (CGI-I) | Week 14 and 20 | — |
| Pittsburgh Sleep Quality Index (PSQI) | Week 0, 7, 14 and 20 | — |
| Modified Patient Health Questionnaire-15 (PHQ-15) | Week 0, 7, 14 and 20 | — |
| Montreal cognitive assessment-telephone version (MoCA-T) | Week 0, 14 and 20 | — |
| Perceived Deficits Questionnaire (PDQ) | Week 0, 7, 14 and 20 | — |
| Patient Health Questionnaire-8 (PHQ-8) | Week 0, 7, 14 and 20 | — |
| Generalised Anxiety Disorder-7 (GAD-7) | Week 0, 7, 14 and 20 | — |
| Work and social adjustment scale (WSAS) | Week 0, 7, 14 and 20 | — |
| Modified DePaul Post exertional malaise questionnaire | Week 0, 7, 14 and 20 | — |
| Post Traumatic Stress Disorder Checklist for DSM 5 (PCL-5) | Week 0, 14 and 20 | — |
| Nijmegen Questionnaire (NQ) | Week 0, 14 and 20 | — |
| Modified Medical Research Council Dyspnea Scale (mMRC) | Week 0, 14 and 20 | — |
| Dyspnoea-12 | Week 0, 14 and 20 | — |
Countries
United Kingdom
Outcome results
None listed