NCT06800040

Brief Summary

The purpose of this study is to assess the feasibility, acceptability, and effectiveness of a 6-week group-based memory training program for individuals experiencing memory problems after acquired brain injury (ABI). Memory impairment is a prevalent consequence of neurological disorders like stroke, traumatic brain injury (TBI), anoxia, brain tumours, or brain infections, collectively termed acquired brain injury (ABI). While memory rehabilitation has shown promise in improving cognitive function in ABI patients, individualised treatments can be resource-intensive and not readily accessible to all in need. The program "Group-Based Memory Rehabilitation to Improve Memory for Everyday Tasks" offers an evidence-based, group-based intervention. Previous studies have demonstrated its efficacy in enhancing everyday memory function, including increased use of memory strategies, achievement of memory-related goals, and improvements in learning ability, both in the subacute and chronic phase post-injury. Furthermore, recent investigations have shown comparable efficacy when delivering the program through telehealth platforms (video conferencing). The investigators have meticulously translated and adapted the memory program to suit Norwegian conditions. As far as the investigators are aware, this is the first time the program has undergone translation and adaptation for Norwegian speakers. This study aims to evaluate the memory program's feasibility, acceptability, and effectiveness in a Norwegian context, aiming to support its implementation in local health services. Both physical face-to-face groups as well as telehealth delivery through videoconferencing will be evaluated. Telehealth delivery will be utilised to overcome geographical barriers and enhance accessibility for patients residing in rural or remote areas in Northern Norway, where rehabilitation services are recognized as an unmet need. A total of five groups will be run during 2025 and 2026. Three of the three groups will be digital via videoconferencing.

Trial Health

75
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
20mo left

Started Feb 2025

Typical duration 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

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Study Timeline

Key milestones and dates

Study Progress43%
Feb 2025Dec 2027

First Submitted

Initial submission to the registry

December 13, 2024

Completed
2 months until next milestone

First Posted

Study publicly available on registry

January 29, 2025

Completed
3 days until next milestone

Study Start

First participant enrolled

February 1, 2025

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2027

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2027

Last Updated

July 22, 2025

Status Verified

January 1, 2025

Enrollment Period

2.9 years

First QC Date

December 13, 2024

Last Update Submit

July 17, 2025

Conditions

Keywords

Memory rehabilitationCognitive rehabilitationAcquired brain injuryRehabilitation after brain injury

Outcome Measures

Primary Outcomes (4)

  • Feasibility of memory training intervention: Demand for the treatment

    The demand for the treatment will be assessed by number of participants enrolled.

    From enrollment to the end of follow up 3 months after the intervention

  • Feasibility of memory training intervention: Adherence

    Adherence to treatment will be measured by dropout rate.

    From enrollment to the end of follow up 3 months after the intervention

  • Feasibility of memory training intervention: Acceptability by participants

    Acceptability by participants will be assessed through perceptions of usefulness, measured by responses to evaluation forms.

    From enrollment to the end of follow up 3 months after the intervention

  • Feasibility of memory training intervention: Format of delivery

    Acceptability of format of delivery (face-to-face and/or telehealth attendance) will be assessed through responses to evaluation forms.

    From enrollment to the end of follow up 3 months after the intervention

Secondary Outcomes (6)

  • Memory training effectiveness

    From enrollment to the end of follow up 3 months after the intervention

  • Memory training effectiveness

    From enrollment to the end of follow up 3 months after the intervention

  • Strategy use

    From enrollment to the end of follow up 3 months after the intervention

  • Objective verbal memory functioning

    From enrollment to the end of follow up 3 months after the intervention

  • Objective visual memory functioning

    From enrollment to the end of follow up 3 months after the intervention

  • +1 more secondary outcomes

Other Outcomes (3)

  • Objective attention functioning

    From enrollment to the end of follow up 3 months after the intervention

  • Emotional symptoms/distress

    From enrollment to the end of follow up 3 months after the intervention

  • Emotional Well-being

    From enrollment to the end of follow up 3 months after the intervention

Study Arms (1)

Memory training

EXPERIMENTAL
Behavioral: Memory training

Interventions

Memory trainingBEHAVIORAL

Memory training

Memory training

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • memory problems.
  • sufficient Norwegian language skills to participate in assessments and group treatment.
  • age between 18 and 75 years.

You may not qualify if:

  • diagnosis of comorbid progressive neurodegenerative disorder, or serious major somatic or psychiatric conditions (e.g bipolar disorder, psychosis, severe depression)
  • major cognitive impairment preventing assessment and group participation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital of North Norway

Tromsø, Norway

Location

MeSH Terms

Conditions

Brain Injuries

Interventions

Cognitive Training

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesCraniocerebral TraumaTrauma, Nervous SystemWounds and Injuries

Intervention Hierarchy (Ancestors)

Neurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head of research

Study Record Dates

First Submitted

December 13, 2024

First Posted

January 29, 2025

Study Start

February 1, 2025

Primary Completion (Estimated)

December 31, 2027

Study Completion (Estimated)

December 31, 2027

Last Updated

July 22, 2025

Record last verified: 2025-01

Locations