Balance Acceptance and Commitment Therapy for Long COVID

Phase 2

Not yet recruiting

• Conditions: Post-COVID-19 Syndrome; Long COVID
• Interventions: Behavioral: Balance Acceptance and Commitment Therapy

• Registration Number: NCT06231238
• Lead Sponsor: King's College London

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2024-01
• Study First Submitted: 2024-01-29
• Study First Submitted QC: 2024-01-29
• Last Update Submitted: 2024-01-29
• Study First Posted: 2024-01-30
• Last Update Posted: 2024-01-30
• Study Start: 2024-03
• Primary Completion: 2025-02
• Study Completion: 2025-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 196

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Balance ACT	Balance Acceptance and Commitment Therapy	Participants randomised to Balance ACT will receive 10 therapy sessions with a therapist.

Primary Outcome Measures

Name	Time	Method
36-item Short Form Health Survey (SF-36)	Week 0, 14 and 20

Secondary Outcome Measures

Name	Time	Method
Modified DePaul Post exertional malaise questionnaire	Week 0, 7, 14 and 20
International Physical Activity Questionnaire - Short Form (IPAQ-SF)	Week 0, 7, 14 and 20
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
Patient Health Questionnaire-8 (PHQ-8)	Week 0, 7, 14 and 20
Modified Medical Research Council Dyspnea Scale (mMRC)	Week 0, 14 and 20
4 metre gait speed	Week 0, 14 and 20
Nijmegen Questionnaire (NQ)	Week 0, 14 and 20
Dyspnoea-12	Week 0, 14 and 20
Muscle fatigue	Week 0, 14 and 20	Handgrip volitional fatigue, Quadriceps non-volitional fatigue
1 minute sit-to-stand test	Week 0, 14 and 20
Short Physical Performance Battery (SPPB)	Week 0, 14 and 20
Montreal cognitive assessment (MoCA)	Week 0, 14 and 20
Perceived Deficits Questionnaire (PDQ)	Week 0, 7, 14 and 20
Lung function (spirometry, Resting pulse oximetry; SpO2)	Week 0, 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 0, 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
Work and social adjustment scale (WSAS)	Week 0, 14 and 20
Muscle strength	Week 0, 14 and 20
Generalised Anxiety Disorder-7 (GAD-7)	Week 0, 7, 14 and 20
Post Traumatic Stress Disorder Checklist (PCL-5)	Week 0, 14 and 20
Heartrate variability	Week 0, 7 and 14
Cognitive and Behavioural Responses Questionnaire (CBRQ)	Week 0, 7, 14 and 20