NCT06973018

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.

Trial Health

75
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
64

participants targeted

Target at P50-P75 for not_applicable

Timeline
20mo left

Started May 2021

Longer than P75 for not_applicable

Geographic Reach
1 country

1 active site

Status
enrolling by invitation

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress75%
May 2021Dec 2027

Study Start

First participant enrolled

May 2, 2021

Completed
4 years until next milestone

First Submitted

Initial submission to the registry

May 7, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

May 15, 2025

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2025

Completed
2.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Expected
Last Updated

May 15, 2025

Status Verified

May 1, 2025

Enrollment Period

4.2 years

First QC Date

May 7, 2025

Last Update Submit

May 7, 2025

Conditions

Keywords

brain injurycognitive rehabilitationnervous system disorderseHealthself assessment

Outcome Measures

Primary Outcomes (1)

  • Mayo Portland Adaptability Inventory - fourth edition (MPAI-4), Participation subscale

    Change in T-score

    Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed

Secondary Outcomes (6)

  • MPAI-4 Adaptability subscale

    Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed

  • MPAI-4 Abilities subscale

    Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed

  • MPAI-4 Total score

    Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed

  • Hospital Anxiety and Depression Scale

    Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed

  • Life Satisfaction Questionnaire (LiSat-11)

    Two weeks before intervention, at intervention start, at the end of treatment at 10 weeks, at six months post intervention ed

  • +1 more secondary outcomes

Other Outcomes (2)

  • Patient satisfaction questionnaire

    End of treatment at 10 weeks

  • Montreal Cognitive Assessment (MoCA)

    Baseline

Study Arms (2)

eRehabCog

EXPERIMENTAL

10 week (1 hour / week, 10 hours in total) internet delivered manualised cognitive rehabilitation

Behavioral: eRehabCog

CogMed QM

ACTIVE COMPARATOR

5 week (2 hours / week, 10 hours in total) internet delivered working memory training program

Behavioral: CogMed QM

Interventions

eRehabCogBEHAVIORAL

eRehabCog is a manualised internet delivered compensatory cognitive rehabilitation program (10 weeks, 1 hour per week, 10 hours in total). It is designed to improve patient self efficacy and participation in everyday life activities through compensatory strategy learning

eRehabCog
CogMed QMBEHAVIORAL

CogMed QM is an internet delivered training program (5 weeks, 2 hours per week, 10 hours in total) designed to improve patients working memory

CogMed QM

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Danderyd Hospital

Stockholm, Stockholm County, 116 88, Sweden

Location

Related Links

MeSH Terms

Conditions

Brain Injuries, TraumaticStrokeMultiple SclerosisParkinson DiseaseBrain InjuriesNervous System Diseases

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and InjuriesCerebrovascular DisordersVascular DiseasesCardiovascular DiseasesDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemDemyelinating DiseasesAutoimmune DiseasesImmune System DiseasesParkinsonian DisordersBasal Ganglia DiseasesMovement DisordersSynucleinopathiesNeurodegenerative Diseases

Study Officials

  • Aniko Bartfai, PhD

    Karolinska Institutet Danderyds Sjukhus (KIDS), Department of medical rehabilitation

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Model Details: Participating teams were randomized to either of the two intervention arms.
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
senior professor in neuropsychology, Karolinska Institutet

Study Record Dates

First Submitted

May 7, 2025

First Posted

May 15, 2025

Study Start

May 2, 2021

Primary Completion

July 1, 2025

Study Completion (Estimated)

December 31, 2027

Last Updated

May 15, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

According to the decision of the ethical review board, IPD can not be shared.

Locations