Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Balance ACT | Experimental | Participants randomised to Balance ACT will receive 10 therapy sessions with a therapist. |
|
| Treatment as usual | No Intervention | Information leaflet about PCS/LC. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Balance Acceptance and Commitment Therapy | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14 | Week 14 |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| King's College London | Camberwell | London | SE5 8AF | United Kingdom |
The datasets generated/analysed during the current study will be anonymised and deposited in King's Open Research Data System. Access to data will be restricted to protect participant confidentiality and comply with applicable data protection legislation. Data will be made available upon reasonable request following publication of the main trial results.
Not provided
Data will be made available at the end of the trial, i.e. usually when all primary and secondary endpoints have been met and all key analyses are complete. Data will remain available from then on for as long as Clinical Trials Unit retains the data.
Access will be granted to qualified researchers upon reasonable request, subject to review and approval by the study team and submission of a prespecified research proposal, in accordance with participant consent and applicable data protection regulations.
Not provided
Not provided
| ID | Term |
|---|---|
| D000094024 | Post-Acute COVID-19 Syndrome |
| ID | Term |
|---|---|
| D000086382 | COVID-19 |
| D011024 | Pneumonia, Viral |
| D011014 | Pneumonia |
| D012141 | Respiratory Tract Infections |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| 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 |
| Dyspnoea-12 | Week 0, 14 and 20 |
| Modified Medical Research Council Dyspnea Scale (mMRC) | Week 0, 14 and 20 |
| Lung function (spirometry, Resting pulse oximetry; SpO2) | Week 0 and 14 |
| Muscle strength | 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. | Week 0, 7, 14 and 20 |
| Muscle fatigue |
| Week 0 and 14 |
| 1 minute sit-to-stand test | 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. | Week 0 and 14 |
| 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 | via electrocardiogram (ECG) | Week 0 and 14 |
| Average Heart-rate | 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. | Week 0 and 14 |
| 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 | Volitional Quadriceps MVC and assessment of quadriceps volitional activation by twitch interpolation using electrical stimulation. | Week 0 and 14 |
| Post COVID Syndrome Recovery (Single Item) | A self-reported single item questionnaire "Do you consider yourself recovered from long COVID?" | Week 7, 14 and 20 |
| 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 |
| D007239 |
| Infections |
| D014777 | Virus Diseases |
| D018352 | Coronavirus Infections |
| D003333 | Coronaviridae Infections |
| D030341 | Nidovirales Infections |
| D012327 | RNA Virus Infections |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D000094025 | Post-Infectious Disorders |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |