Balance Acceptance and Commitment Therapy for Long COVID

NCT06231238 | Active Not Recruiting DMC

• 1 other identifier: 326529
• Study Type: interventional
• Target: 196
• Locations: 1 country
• Sites: 1

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.

Conditions

Post-COVID-19 Syndrome; Long COVID

Outcome Measures

Primary Outcomes (1)

• Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 14

  Week 14

Secondary Outcomes (32)

• 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)

  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

Study Arms (2)

Balance ACT

EXPERIMENTAL

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

Behavioral: Balance Acceptance and Commitment Therapy

Treatment as usual

NO INTERVENTION

Information leaflet about PCS/LC.

Interventions

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.

Balance ACT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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
• Pregnancy

Sponsors & Collaborators

• King's College London: lead

Study Sites (1)

King's College London

Camberwell, London, SE5 8AF, United Kingdom

Location

MeSH Terms

Conditions

Post-Acute COVID-19 Syndrome

Condition Hierarchy (Ancestors)

COVID-19; Pneumonia, Viral; Pneumonia; Respiratory Tract Infections; Infections; Virus Diseases; Coronavirus Infections; Coronaviridae Infections; Nidovirales Infections; RNA Virus Infections; Lung Diseases; Respiratory Tract Diseases; Post-Infectious Disorders; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 29, 2024
• First Posted: January 30, 2024
• Study Start: June 4, 2024
• Primary Completion: May 30, 2026
• Study Completion: August 1, 2026
• Last Updated: July 2, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• 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.
• 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.

Locations

GB (1)