Clinical trial NCT06231238: Balance Acceptance and Commitment Therapy for Long COVID
Official title: A Randomised Controlled Trial Assessing the Efficacy of Balance Acceptance and Commitment Therapy (ACT) for Long COVID.
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Post-COVID-19 Syndrome
Long COVID
Lead sponsor: King's College London
Sponsor class: OTHER
First posted: 2024-01-30
Enrollment: 196
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility criteria: 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

Primary outcomes:
measure: 36-item Short Form Health Survey (SF-36)
timeFrame: Week 0, 14 and 20
Secondary outcomes:
measure: EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)
timeFrame: Week 0, 14 and 20
measure: Service use
timeFrame: Week 0 and 20
measure: Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)
timeFrame: Week 0, 7, 14 and 20
measure: Modified Clinical Global Impressions Scale- Improvement (CGI-I)
timeFrame: Week 0, 14 and 20
measure: Pittsburgh Sleep Quality Index (PSQI)
timeFrame: Week 0, 7, 14 and 20
measure: Modified Patient Health Questionnaire-15 (PHQ-15)
timeFrame: Week 0, 7, 14 and 20
measure: Montreal cognitive assessment (MoCA)
timeFrame: Week 0, 14 and 20
measure: Perceived Deficits Questionnaire (PDQ)
timeFrame: Week 0, 7, 14 and 20
measure: Patient Health Questionnaire-8 (PHQ-8)
timeFrame: Week 0, 7, 14 and 20
measure: Generalised Anxiety Disorder-7 (GAD-7)
timeFrame: Week 0, 7, 14 and 20
measure: Work and social adjustment scale (WSAS)
timeFrame: Week 0, 14 and 20
measure: Modified DePaul Post exertional malaise questionnaire
timeFrame: Week 0, 7, 14 and 20
measure: Post Traumatic Stress Disorder Checklist (PCL-5)
timeFrame: Week 0, 14 and 20
measure: Nijmegen Questionnaire (NQ)
timeFrame: Week 0, 14 and 20
measure: Dyspnoea-12
timeFrame: Week 0, 14 and 20
measure: Modified Medical Research Council Dyspnea Scale (mMRC)
timeFrame: Week 0, 14 and 20
measure: Lung function (spirometry, Resting pulse oximetry; SpO2)
timeFrame: Week 0, 14 and 20
measure: Muscle strength
timeFrame: Week 0, 14 and 20
measure: Muscle fatigue
timeFrame: Week 0, 14 and 20
measure: 1 minute sit-to-stand test
timeFrame: Week 0, 14 and 20
measure: 4 metre gait speed
timeFrame: Week 0, 14 and 20
measure: Short Physical Performance Battery (SPPB)
timeFrame: Week 0, 14 and 20
measure: International Physical Activity Questionnaire - Short Form (IPAQ-SF)
timeFrame: Week 0, 7, 14 and 20
measure: Heartrate variability
timeFrame: Week 0, 7 and 14
measure: Cognitive and Behavioural Responses Questionnaire (CBRQ)
timeFrame: Week 0, 7, 14 and 20
measure: Comprehensive assessment of Acceptance and Commitment Therapy processes
timeFrame: Week 0, 7, 14 and 20
Other outcomes:
Locations:
Study officials:
References: