Balance Acceptance and Commitment Therapy for Long COVID

Long COVID Clinical Trial

— BalanceACT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06231238
• Other study ID #: 326529
• Status: Not yet recruiting
• Phase: Phase 2
• 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
• 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

Related Conditions & MeSH terms

• Long COVID
• Post-COVID-19 Syndrome

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