A Randomised Controlled Trial Assessing the Efficacy of Balance Acceptance and Commitment Therapy (ACT) for Long COVID.

King's College London1 site in 1 country196 target enrollmentJune 4, 2024

ConditionsPost-COVID-19 Syndrome Long COVID

InterventionsBalance Acceptance and Commitment Therapy

Overview

Phase: N/A
Intervention: Balance Acceptance and Commitment Therapy
Conditions: Post-COVID-19 Syndrome
Sponsor: King's College London
Enrollment: 196
Locations: 1
Primary Endpoint: 36-item Short Form Health Survey (SF-36)
Status: Active, Not Recruiting
Last Updated: 2 months ago

Overview Investigators Eligibility Criteria Arms & Interventions Outcomes Sites Similar Trials

Overview

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.

Registry

clinicaltrials.gov

Start Date

June 4, 2024

End Date

June 1, 2026

Last Updated

2 months ago

Study Type

Interventional

Study Design

Parallel

Sex

All

Investigators

Sponsor

King's College London

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Age 18 or older
•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
•Ability to travel to the research site for the study assessments
•Having registered with a General Practitioner (GP) in the United Kingdom (UK) and consent to provide their details for the study team to contact
•Ability to provide informed consent
•Ability to read and write English

Exclusion Criteria

•Current diagnosis of an active major mental health disorder likely to interfere with participation
•Unstable alcohol / drug dependency
•Unstable complications associated with LC/PCS
•Past hospitalisation for COVID-19
•Current or recent participation in other treatment intervention studies (\<4 weeks after completion)
•Currently receiving psychological support or psychotherapy

Arms & Interventions

Balance ACT

Participants randomised to Balance ACT will receive 10 therapy sessions with a therapist.

Intervention: Balance Acceptance and Commitment Therapy

Treatment as usual

Information leaflet about PCS/LC.

Outcomes

Primary Outcomes

36-item Short Form Health Survey (SF-36)

Time Frame: Week 0, 7, 14 and 20

Secondary Outcomes

EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)(Week 0, 14 and 20)
Service use(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 (MoCA)(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 (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(Week 0, 7, 14 and 20)
Muscle fatigue(Week 0 and 14)
1 minute sit-to-stand test(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(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(Week 0 and 14)