Skip to main content
MedPath Trial logoMedPath TrialMedPath Trial Home
Clinical Trials/NCT06231238
NCT06231238Active, not recruitingNot Applicable

A Randomised Controlled Trial Assessing the Efficacy of Balance Acceptance and Commitment Therapy (ACT) for Long COVID.

King's College London1 site in 1 country196 target enrollmentStarted: June 4, 2024Last updated:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Active, not recruiting
Enrollment
196
Locations
1
Primary Endpoint
36-item Short Form Health Survey (SF-36)
Study OverviewStudy DesignEligibility CriteriaArms & InterventionsOutcomesInvestigatorsSitesRecords & IdentifiersSimilar Trials

Study Overview

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.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
Double (Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to — (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • •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

Exclusion Criteria

  • •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

Arms & Interventions

Treatment as usual

No Intervention

Information leaflet about PCS/LC.

Balance ACT

Experimental

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

Intervention: Balance Acceptance and Commitment Therapy (Behavioral)

Outcomes

Primary Outcomes

36-item Short Form Health Survey (SF-36)

Time Frame: Week 0, 7, 14 and 20

Secondary Outcomes

  • 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)
  • Modified Clinical Global Impressions Scale- Improvement (CGI-I)(Week 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)
  • Montreal cognitive assessment (MoCA)(Week 0, 14 and 20)
  • Perceived Deficits Questionnaire (PDQ)(Week 0, 7, 14 and 20)
  • Patient Health Questionnaire-8 (PHQ-8)(Week 0, 7, 14 and 20)
  • Generalised Anxiety Disorder-7 (GAD-7)(Week 0, 7, 14 and 20)
  • Work and social adjustment scale (WSAS)(Week 0, 7, 14 and 20)
  • Modified DePaul Post exertional malaise questionnaire(Week 0, 7, 14 and 20)
  • Post Traumatic Stress Disorder Checklist (PCL-5)(Week 0, 14 and 20)
  • Nijmegen Questionnaire (NQ)(Week 0, 14 and 20)
  • Dyspnoea-12(Week 0, 14 and 20)
  • Modified Medical Research Council Dyspnea Scale (mMRC)(Week 0, 14 and 20)
  • Lung function (spirometry, Resting pulse oximetry; SpO2)(Week 0 and 14)
  • Modified Medical Research Council Dyspnea Scale (mMRC)(Week 0, 14 and 20)
  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Week 0, 7, 14 and 20)
  • Cognitive and Behavioural Responses Questionnaire (CBRQ)(Week 0, 7, 14 and 20)
  • Modified DePaul Post exertional malaise questionnaire(Week 0, 7, 14 and 20)
  • Nijmegen Questionnaire (NQ)(Week 0, 14 and 20)
  • Dyspnoea-12(Week 0, 14 and 20)
  • EuroQol 5 Dimension - 5 Levels (EQ-5D-5L)(Week 0, 14 and 20)
  • Functional Assessment of Chronic Illness Therapy - Fatigue (FACIT-F)(Week 0, 7, 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)
  • Perceived Deficits Questionnaire (PDQ)(Week 0, 7, 14 and 20)
  • Patient Health Questionnaire-8 (PHQ-8)(Week 0, 7, 14 and 20)
  • Generalised Anxiety Disorder-7 (GAD-7)(Week 0, 7, 14 and 20)
  • Average Heart-rate(Week 0 and 14)
  • Physical Component Summary (PCS) of the 36-item Short Form Health Survey (SF-36) at Week 20(Week 0, 7, and 20)
  • Mental Component Summary (MCS) of the 36-item Short Form Health Survey (SF-36)(Week 0, 7, 14 and 20)
  • Heartrate variability(Week 0 and 14)
  • Muscle strength(Week 0, 7, 14 and 20)
  • Muscle fatigue(Week 0 and 14)
  • 4 metre gait speed(Week 0 and 14)
  • Short Physical Performance Battery (SPPB)(Week 0 and 14)
  • International Physical Activity Questionnaire - Short Form (IPAQ-SF)(Week 0, 7, 14 and 20)
  • Cognitive and Behavioural Responses Questionnaire (CBRQ)(Week 0, 7, 14 and 20)
  • Comprehensive assessment of Acceptance and Commitment Therapy processes(Week 0, 7, 14 and 20)
  • Quadricep Muscle Strength(Week 0 and 14)
  • 1 minute sit-to-stand test(Week 0 and 14)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

Study Sites (1)

Loading locations...

Similar Trials

Completed
Not Applicable
Psychological Support Based on Positive Suggestions (PSBPS) on Mental Health Morbidity and Cognitive FunctionCritical Illness
NCT04045210Mayo Clinic274
Not yet recruiting
Not Applicable
Evaluation of the Effectiveness of the Combined Psychological Resilience and Self-efficacy Intervention for Improving Resilience and Self-efficacy and Reducing Anxiety and Depression of Oesophageal Cancer Surgery PatientsEsophageal Cancer
NCT06484842Anhui Medical University123
Completed
Not Applicable
Psychological Intervention to Reduce Weight Bias InternalizationStigmatizationWeight LossObesity
NCT03572218University of Pennsylvania72
Completed
Not Applicable
A Brief Acceptance Intervention for Stress to Improve Students' Well-BeingStress
NCT06335615VU University of Amsterdam116
Terminated
Not Applicable
Effectiveness Study of a Treatment to Improve the Mental Health of Children and AdolescentsChild Mental DisorderBehavior Problem
NCT03075475Johns Hopkins Bloomberg School of Public Health83