Clinical trial NCT06973018: Internet Delivered Cognitive Rehabilitation for Mild Cognitive Impairments
Official title: Internetförmedlad Kognitiv Rehabilitering Vid Lindrig Kognitiv störning
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Traumatic Brain Injury
Stroke
Multiple Sclerosis
Parkinsons Disease (PD)
Post-COVID-19 Condition
Keywords: brain injury
cognitive rehabilitation
nervous system disorders
eHealth
self assessment
Lead sponsor: Danderyd Hospital
Sponsor class: OTHER
Collaborators: name: Region Stockholm
First posted: 2025-05-15
Enrollment: 64
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participating teams were randomized to either of the two intervention arms.
Primary purpose: TREATMENT

Brief summary: Acquired brain injury and neurological disorders cause cognitive deficits, which in turn cause reduced participation in everyday life. Cognitive rehabilitation, where patients learn about cognition, cognitive deficits and ways to circumvent problems arising from deficits can increase participation and quality of life. ERehabCog is an internet delivered cognitive rehabilitation program intended for patients suffering mild to moderate impairments. The program consists of information and homework assignments, which take approximately 10 weeks to complete with the assistance of a therapist. Effects are evaluated through measures of everyday life participation, mood, and life satisfaction and compared with an attention training program. This study aims to contribute to the evidence base for internet delivered cognitive rehabilitation for mild to moderate cognitive impairments. Evidence based interventions are vital to use the potential of technology to the benefit of affected patients.

Detailed description: When broadly defined, diseases and injuries affecting the central nervous system are one of the leading causes of disease burden in the world affecting more than 3 billion people. With such a large proportion of the global population affected, optimization of limited resources in the form of specialized rehabilitation is instrumental to ensuring sustainable public health.

The consequences of acquired brain injuries (ABIs) and neurological disorders are multifaceted, causing diminished functional capacity in a range of areas. Cognitive impairments are common, affecting ability to work, take on reponsibilities at home and in the community. Relationships in all significant life areas can be disrupted. As a result, patients may experience a significant shift in a plurality of life roles. Rehabilitation aims to help patients recapture premorbid capacities and reduce the impact of deficits while considering the needs and context of the patient. Cognitive rehabilitation has the potential to ameliorate patient outcomes. Patients in Sweden are offered cognitive rehabilitation as a part of multimodal rehabilitation programs, typically provided in university hospital settings. The demand for such interventions is greater than the amount provided. Patients with mild cognitive deficits are generally less prioritized than those with greater impairments. Internet provided rehabilitation programs can increase the accessibility of cognitive rehabilitation.

eRehabCog is an internet-delivered 10 module cognitive rehabilitation program designed to aid patients experiencing mild to moderate cognitive deficits following acquired brain injury or neurological disorders. The philosophy behind the development of eRehabCog is grounded in a compensatory-metacognitive approach. That is to say, patients learn about cognitive functions, consequences of deficits and ways to compensate. This approach has both a practical component where patients learn strategies they may use in their everyday life and a self-reflective component where patients learn to think about their thinking in such a way to raise their awareness of their functioning.

CogMed QM is a 10 week digital working memory training program which has been evaluated in children with ADHD and adults with stroke, showing improvements in working memory function. CogMed QM is a restitutive training program, intended to help patients retake diminished working memory capacity.

The overall aim of this study is to evaluate the efficacy of eRehabCog for patients experiencing mild to moderate cognitive deficits. Specific aims are to 1) evaluate the efficacy of eRehabCog for patients with ABI and ND admitted to community neurorehabilitation 2) compare the effects of eRehabCog to CogMed QM

The study will recruit 64 patients enrolled in community neurorehabilitation. Patients recruited will be ≥ 18 years old, have obtained a score ≥ 21 on Montreal Cognitive Assessment (MoCA), living in their home, with our without assistance and with access to computer and/or functionally ecquivalent device. Exclusion criteria will be progressive neurocognitive impairment (i.e dementia), substance abuse, insufficient Swedish language capabilities, insufficiently stable living situation to commit to a 10 week long program. Community neurorehabilitation teams participating in the study will be randomized to either eRehabCog or CogMed QM.

The primary outcome measure is the Mayo Portland Adaptability Inventory - Fourth edition (MPAI-4) Participation.

Secondary outcome measures are MPAI-4 Total score, ability and adjustment, Hospital Anxiety and Depression Scale (HADS), Life Satisfaction Scale - 11 items (LiSat-11), Community Integration Questionnaire - revised (CIQ-R) and Patient Satisfaction Questionnaire (PSQ).

Background information on patients general status including socioeconomic factors and medical factors such as time since diagnosis is also collected. Behavioural measures such as time in the program, amount of messages to therapist and number of logins are additionally collected throughout participation.

Eligibility criteria: Inclusion Criteria:

* Enrolled in community neurorehabilitation in Stockholm, Sweden
* Mild to moderate cognitive impairment as a consequence of acquired brain injury or nervous system disease
* MoCA 21 ≥
* Sufficient command of Swedish language
* Access to internet connected device and internet connection

Exclusion Criteria:

* Severe and enduring psychiatric or behavioural disorders (i.e Schizophrenia, substance abuse)
* Suspected or diagnosed dementia
* Homelessness or other social instability rendering access to internet unpredictable

Primary outcomes:
measure: Mayo Portland Adaptability Inventory - fourth edition (MPAI-4), Participation subscale
timeFrame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Secondary outcomes:
measure: MPAI-4 Adaptability subscale
timeFrame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
measure: MPAI-4 Abilities subscale
timeFrame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
measure: MPAI-4 Total score
timeFrame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
measure: Hospital Anxiety and Depression Scale
timeFrame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
measure: Life Satisfaction Questionnaire (LiSat-11)
timeFrame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
measure: Community Integration Questionnaire - Revised (CIQ-R)
timeFrame: Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed
Other outcomes:
measure: Patient satisfaction questionnaire
timeFrame: End of treatment at 10 weeks
measure: Montreal Cognitive Assessment (MoCA)
timeFrame: Baseline
Locations:
city: Stockholm
country: Sweden
facility: Danderyd Hospital
Study officials:
affiliation: Karolinska Institutet Danderyds Sjukhus (KIDS), Department of medical rehabilitation
name: Aniko Bartfai, PhD
role: PRINCIPAL_INVESTIGATOR
References: