Balance Acceptance and Commitment Therapy for Long COVID (BalanceACT)

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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Post-COVID-19 Syndrome; Long COVID
• Intervention / Treatment: Behavioral: Balance Acceptance and Commitment Therapy

• Study Type: Interventional
• Enrollment (Estimated): 196
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United Kingdom
  • London
    • Camberwell, London, United Kingdom, SE5 8AF
      • King's College London

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Balance ACT; Participants randomised to Balance ACT will receive 10 therapy sessions with a therapist.	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.
No Intervention: Treatment as usual; Information leaflet about PCS/LC.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14	Week 14

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)		Week 0, 14 and 20
Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)		Week 0, 7, 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
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
Modified DePaul Post exertional malaise questionnaire		Week 0, 7, 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
International Physical Activity Questionnaire - Short Form (IPAQ-SF)		Week 0, 7, 14 and 20
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
Modified Clinical Global Impressions Scale- Improvement (CGI-I)		Week 14 and 20
Work and social adjustment scale (WSAS)		Week 0, 7, 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	Handgrip volitional fatigue: A digital grip force transducer will be used to assess volitional handgrip fatigue.; Quadriceps non-volitional fatigue: Quadriceps muscle endurance will be assessed non-volitionally using transcutaneous electrical stimulation.	Week 0 and 14
4 metre gait speed		Week 0 and 14
Short Physical Performance Battery (SPPB)		Week 0 and 14
Quadricep Muscle Strength	Volitional Quadriceps MVC and assessment of quadriceps volitional activation by twitch interpolation using electrical stimulation.	Week 0 and 14
Adult Service Use Schedule		Week 0 and 20
Montreal cognitive assessment-telephone version (MoCA-T)		Week 0, 14 and 20
Post Traumatic Stress Disorder Checklist for DSM 5 (PCL-5)		Week 0, 14 and 20
Heartrate variability	via electrocardiogram (ECG)	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
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
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
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

Collaborators and Investigators

• Sponsor: King's College London

Study record dates

Study Major Dates

• Study Start (Actual): June 4, 2024
• Primary Completion (Actual): May 30, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: January 29, 2024
• First Submitted That Met QC Criteria: January 29, 2024
• First Posted (Actual): January 30, 2024

Study Record Updates

• Last Update Posted (Actual): July 2, 2026
• Last Update Submitted That Met QC Criteria: July 1, 2026
• Last Verified: June 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Post-Infectious Disorders; COVID-19; Pathologic Processes; Chronic Disease; Disease Attributes; Respiratory Tract Infections; Infections; RNA Virus Infections; Virus Diseases; Respiratory Tract Diseases; Lung Diseases; Pneumonia, Viral; Pneumonia; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; Pathological Conditions, Signs and Symptoms; Post-Acute COVID-19 Syndrome
• Other Study ID Numbers: 326529

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: 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.
• IPD Sharing Access Criteria: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No