Balance Acceptance and Commitment Therapy for Long COVID

N/AActive Not RecruitingNCT06231238

King's College London196 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

196

Conditions

Post-COVID-19 Syndrome Long COVID

Interventions

Balance Acceptance and Commitment TherapyBEHAVIORAL

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.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (1)

King's College London

Camberwell, London, United Kingdom

Outcomes

Primary Outcomes

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

Time frame: Week 14

Secondary Outcomes

EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)

Time frame: Week 0, 14 and 20

Adult Service Use Schedule

Time frame: Week 0 and 20

Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)

Time frame: Week 0, 7, 14 and 20

Modified Clinical Global Impressions Scale- Improvement (CGI-I)

Time frame: Week 14 and 20

Pittsburgh Sleep Quality Index (PSQI)

Time frame: Week 0, 7, 14 and 20

Modified Patient Health Questionnaire-15 (PHQ-15)

Time frame: Week 0, 7, 14 and 20

Montreal cognitive assessment-telephone version (MoCA-T)

Time frame: Week 0, 14 and 20

Perceived Deficits Questionnaire (PDQ)

Time frame: Week 0, 7, 14 and 20

Patient Health Questionnaire-8 (PHQ-8)

Time frame: Week 0, 7, 14 and 20

Generalised Anxiety Disorder-7 (GAD-7)

Time frame: Week 0, 7, 14 and 20

Work and social adjustment scale (WSAS)

Data from ClinicalTrials.gov

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Time frame: Week 0, 7, 14 and 20

Modified DePaul Post exertional malaise questionnaire

Time frame: Week 0, 7, 14 and 20

Post Traumatic Stress Disorder Checklist for DSM 5 (PCL-5)

Time frame: Week 0, 14 and 20

Nijmegen Questionnaire (NQ)

Time frame: Week 0, 14 and 20

Dyspnoea-12

Time frame: Week 0, 14 and 20

Modified Medical Research Council Dyspnea Scale (mMRC)

Time frame: Week 0, 14 and 20

Lung function (spirometry, Resting pulse oximetry; SpO2)

Time frame: Week 0 and 14

Muscle strength

Handgrip muscle strength: A handgrip dynamometer will be used to measure grip strength. The dynamometer will be placed in the participant's hand and the participant will be instructed to squeeze as hard as possible.

Time frame: Week 0, 7, 14 and 20

Muscle fatigue

1. Handgrip volitional fatigue: A digital grip force transducer will be used to assess volitional handgrip fatigue. 2. Quadriceps non-volitional fatigue: Quadriceps muscle endurance will be assessed non-volitionally using transcutaneous electrical stimulation.

Time frame: Week 0 and 14

1 minute sit-to-stand test

Participants will also be shown the Borg Rating of Perceived Exertion Scale and asked to rate their perceived breathlessness and leg fatigue prior to the start of the test, immediately after completion of the test, and following one minute of recovery.

Time frame: Week 0 and 14

4 metre gait speed

Time frame: Week 0 and 14

Short Physical Performance Battery (SPPB)

Time frame: Week 0 and 14

International Physical Activity Questionnaire - Short Form (IPAQ-SF)

Time frame: Week 0, 7, 14 and 20

Heartrate variability

via electrocardiogram (ECG)

Time frame: Week 0 and 14

Average Heart-rate

Average Heart-rate will be assessed from 5 minutes of a 10-minute resting 3 lead electrocardiogram (ECG). These short-term recordings provide a non-invasive measure of autonomic nervous system function.

Time frame: Week 0 and 14

Cognitive and Behavioural Responses Questionnaire (CBRQ)

Time frame: Week 0, 7, 14 and 20

Comprehensive assessment of Acceptance and Commitment Therapy processes

Time frame: Week 0, 7, 14 and 20

Quadricep Muscle Strength

Volitional Quadriceps MVC and assessment of quadriceps volitional activation by twitch interpolation using electrical stimulation.

Time frame: Week 0 and 14

Post COVID Syndrome Recovery (Single Item)

A self-reported single item questionnaire "Do you consider yourself recovered from long COVID?"

Time frame: Week 7, 14 and 20

Treatment Satisfaction Questionnaire

Time frame: Week 14

Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 20

Time frame: Week 0, 7, and 20

Mental Component Summary (MCS) of the 36-item Short Form Health Survey (SF-36)

Time frame: Week 0, 7, 14 and 20