Cognitive Rehabilitation in Post-COVID-19 Condition

COVID-19 Clinical Trial

— TRAINCOVID  

Official title:

Cognitive Rehabilitation in Post-COVID-19 Condition: A Study Protocol for a Randomized Controlled Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05494424
• Other study ID #: Traincovid
• Status: Recruiting
• Phase: N/A
• Start date: September 8, 2023
• Est. completion date: January 2029

Study information

• Verified date: September 2023
• Source: Lovisenberg Diakonale Hospital
• Contact: Head of Research at Lovisenberg Hospital
• Phone: (+47) 95033144
• Email: anners.lerdal[@]lds.no
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Post-COVID-19 condition is frequently comprised of persistent cognitive sequela, including deficits in attention and executive functions (EFs). Goal Management Training (GMT) is a cognitive rehabilitation (CR) intervention for improving attention and EFs that has received empirical support in studies of other patient groups. The present study aims to determine the efficacy of GMT for improving everyday attention and EFs in adults who experience persistent cognitive deficits after COVID-19. The study is a randomized controlled trial (RCT), comparing the efficacy of GMT to a wait list control condition (WL), for improving persistent cognitive sequela in post-COVID-19 condition. The study aims to recruit 240 participants aged 18 to 65 years with a history of laboratory- or home-test confirmed, SARS-CoV-2 infection (> 3 months since infection) and perceived attentional and EF difficulties in daily life that have lasted for at least two months and that cannot be explained by an alternative diagnosis. Participants will be randomized to either group-based GMT (n = 120) or WL (n = 120). GMT will be internet-delivered to groups of six participants in six two-hour sessions delivered weekly (five weeks). The primary outcome will be the Metacognition Index of the Behavior Rating Inventory of Executive Function - Adult Version, a self-report measure assessing everyday EF difficulties, at six months post-treatment. Secondary outcomes include performance-based neurocognitive measures and rating scales of cognition, emotional health, quality of life, and fatigue. Secondary aims include to explore to what extent potential early change predicts outcome, and to examine what characterize those who profit from GMT, in addition to describe the neurocognitive and emotional health in a Covid-19 sample. The investigators will also examine potential effects of GMT at 2- and 5-year follow-up.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 240
• Est. completion date: January 2029
• Est. primary completion date: July 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• history of laboratory- or home-test confirmed, SARS-CoV-2 infection (> 3 months since infection)
• perceived cognitive difficulties (attention, memory, EF) affecting everyday functioning that have lasted for at least two months and that cannot be explained by an alternative diagnosis
• age between 18-65 years

Exclusion Criteria:

• ongoing alcohol- or substance abuse, premorbid insult and/or comorbid neurological disease, severe neurocognitive problems interfering with the capacity to participate, sensory disorders biasing cognitive assessment, psychotic disorders, lack of proficiency in Norwegian, and being previously enrolled in a GMT trial.

Related Conditions & MeSH terms

• COVID-19

Intervention

Behavioral:
• Goal Management Training (GMT)
Goal Management Training is a cognitive rehabilitation intervention that relies on metacognitive strategies to reengage top-down attention processes, in addition to teaching problem-solving techniques, attempting to address executive dysfunctions.

Locations

Country	Name	City	State
Norway	Lovisenberg Diaconal Hospital	Oslo

Sponsors (6)

Lead Sponsor	Collaborator
Lovisenberg Diakonale Hospital	Icahn School of Medicine at Mount Sinai, Oslo University Hospital, UiT The Arctic University of Norway, University of Oslo, University of Toronto

Country where clinical trial is conducted

Norway, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The Metacognition Index from the Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)	Self-report measure of daily life executive function (metacognition). Range:70-210. Higher score indicate greater executive dysfunction.	Change from baseline up to 6 months
Secondary	The Behaviour regulation Index from Behavior Rating Inventory of Executive Function - Adult Version (BRIEF-A)	Self-report measure of daily life executive function (behaviour regulation). Range: 70-210. Higher score indicate greater executive dysfunction.	Change from baseline up to 6 months
Secondary	Cambridge Neuropsychological Test Automated Battery (CANTAB), subtests: the Stop Signal Task, Spatial Working Memory, Intra-Extra Dimensional Set Shift and Rapid Visual Information Processing	Performance-based neurocognitive test battery	Change from baseline up to 6 months
Secondary	The Hospital Anxiety and Depression Scale	Self-report measure of symptoms of anxiety and depression. The maximum score is 21 for depression and 21 for anxiety, range 0-21 on each scale. A higher score = more symptoms.	Change from baseline up to 6 months
Secondary	The Generalized Self-Efficacy Scale	Self-report measure of self-efficacy. Range:10-40. Higher score indicate higher self-efficacy.	Change from baseline up to 6 months
Secondary	Fatigue Severity Scale	Self-report measure of fatigue. 7 items. Range 7-49. Higher score indicate more fatigue.	Change from baseline up to 6 months
Secondary	The Perceived Deficits Questionnaire	Self-report measure of daily-life cognitive difficulties. The total score range from 0 to 80, with a higher score indicating greater perceived cognitive impairment.	Change from baseline up to 6 months
Secondary	Everyday Memory Questionnaire	Self-report measure of daily-life cognitive difficulties. The total score range from 0 to 52, with a higher score indicating greater perceived cognitive impairment.	Change from baseline up to 6 months
Secondary	RAND 12-Item Health Survey (RAND-12)	Self-report measure of quality of life. Range 0-10; a high score defines a more favorable health state.	Change from baseline up to 6 months
Secondary	EuroQol five-dimension scale questionnaire (EQ-5D)	Self-report measure of quality of life. The range of the EQ-5D index scores is 0 to 1 (1 indicates the best health state), but negative scores as low as-0.59 are possible for health states deemed to be worse than death.	Change from baseline up to 6 months
Secondary	DUKE-UNC Functional Social Support Questionnaire (FSSQ)	Self-report measure of social support. 8 items. The total score range from 8 to 40. Higher score indicates more social support.	Change from baseline up to 6 months
Secondary	DePaul Symptom Questionnaire short version	Self-report measure of fatigue symptoms. 14 items. The total score range from 0 to 56 for both frequency and severity for each item.	Change from baseline up to 6 months
Secondary	The Resilience Scale for Adults	Self-report measure of resilience. 33 items. The total score range from 33 to 165	Change from baseline up to 6 months