Balance Acceptance and Commitment Therapy for Long COVID (BalanceACT)

King's College London

Status: Enrolling

Conditions: Long COVID; Post-COVID-19 Syndrome

Treatments: Behavioral: Balance Acceptance and Commitment Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT06231238

326529

Details and patient eligibility

About

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.

Enrollment: 196 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

196 participants in 2 patient groups

Balance ACT

Experimental group

Description:

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

Treatment:

Behavioral: Balance Acceptance and Commitment Therapy

Treatment as usual

No Intervention group

Description:

Information leaflet about PCS/LC.