Acquired Brain Injury (Including Stroke)NCT06800040
Testing a Group Memory Training Program for People With Brain Injuries
A study testing Memory training in people with Acquired Brain Injury (Including Stroke), run by University Hospital of North Norway at 1 site in Norway.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Acquired Brain Injury (Including Stroke)
- What is being tested?
- Memory training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteNorway
- Study dates
- 1 Feb 2025to 31 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- history of ABI (stroke/cerebrovascular incidents, traumatic brain injury, anoxia, non-progressive brain tumour, brain infection, or other non-progressive ABI) at least 6 months prior to inclusion.
- memory problems.
- sufficient Norwegian language skills to participate in assessments and group treatment.
- age between 18 and 75 years.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Evaluating the Feasibility and Effectiveness of a Group-Based Memory Rehabilitation Program for Acquired Brain Injury (ABI) Patients
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.
Read more
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.
Read the detailed description
This manualized, group-based memory intervention involves six weekly, two-hour sessions (including a break). Group sizes should be from 3 to 10 participants, as recommended by the developers, with two group leaders (psychologists/neuropsychologists). Each session encompasses education about memory and factors influencing optimal memory function, and training in the use of compensatory memory strategies (both internal strategies and external memory aids). Group exercises and discussions, as well as homework tasks between sessions, are used to facilitate learning and generalisation of memory skills. The two-hour sessions are divided into approximately 15 minutes for reviewing homework and repetition from previous sessions; 20-30 minutes for the educational component; 60-80 minutes for practising strategies and discussing their application; 10 minutes for a break. Full details of the memory intervention, including instructional guidelines, description of exercises, handouts and supporting materials, can be found in the published manual.
The memory training program will constitute a new treatment intervention in the health region of Northern Norway, and the need to carry out feasibility studies as part of the development of complex interventions has been pointed out. Hence, the objective of this study is to identify and evaluate obstacles to delivery and implementation of the program through a feasibility and acceptability study. Effectiveness of the intervention will depend on sufficient feasibility, and will also be evaluated.
The study has two aims. First, the investigators aim to explore the feasibility of delivering the intervention, and the patients acceptability of the intervention, in order to achieve optimal efficacy.
Second, the investigators will explore the effectiveness of the memory training program on participants' memory functioning.
Research question 1 What is the feasibility of the intervention, considering a) the demand for the treatment as assessed through a) Recruitment, b) Adherence, c) Acceptability by participants, and d) Format of delivery.
Research question 2 Does a group-based 6 week memory training program improve objective and subjective memory functioning in individuals with memory complaints after ABI? The aim of the program is to enhance memory functioning on one or more measures of subjective and objective memory, number of memory strategies used in daily life, and/or personal goal attainment.
- Conditions
- Acquired Brain Injury (Including Stroke)
- Being tested
- Memory training
- Keywords
- Memory rehabilitation, Cognitive rehabilitation, Acquired brain injury, Rehabilitation after brain injury
- Medical subject headings
- Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Memory trainingBehavioural
Memory training
| Study group | Role | What they receive |
|---|---|---|
| Memory training | Experimental | Not described Receives: Behavioral: Memory training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of memory training intervention: Demand for the treatment
The demand for the treatment will be assessed by number of participants enrolled.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From enrollment to the end of follow up 3 months after the intervention
Secondary outcomes (6)
Memory training effectiveness
Subjective memory problems in everyday life will be measured by responses to The Everyday Memory Questionnaire - revised (EMQ-R). The EMQ-R is a 13-item scale developed as a measure of self-reported memory failures of everyday life. It is evaluated with a five-point Likert scale whereby higher scores indicate greater frequency of memory lapses.
Measured: From enrollment to the end of follow up 3 months after the intervention
Memory training effectiveness
Subjective memory problems in everyday life will be measured by responses to the Prospective and Retrospective Memory Questionnaire (PRMQ). The Prospective and Retrospective Memory Questionnaire (PRMQ) is a self-report measure of prospective and retrospective memory slips in everyday life, which allows participants to rate the frequency of the two forms of memory failures on a five-point Likert-scale, ranging from "very often" (5) to "never" (1). It is a 16-item scale, 8 items asking about prospective memory failures, and 8 concerning retrospective memory failures.
Measured: From enrollment to the end of follow up 3 months after the intervention
Strategy use
Description of type and number of internal and external memory strategies participants employ in their everyday life before and after the intervention, will be registered with pre- and post-evaluation forms from the published manual.
Measured: From enrollment to the end of follow up 3 months after the intervention
Objective verbal memory functioning
Memory impairment/objective memory functioning will be assessed with standardised a neuropsychological test of verbal memory (Rey Auditory Verbal Learning Test - RAVLT).
Measured: From enrollment to the end of follow up 3 months after the intervention
Objective visual memory functioning
Memory impairment/objective memory functioning will be assessed with a standardised neuropsychological tests of visual memory (Brief Visuospatial Memory Test-Revised - BVMT-R).
Measured: From enrollment to the end of follow up 3 months after the intervention
Personal memory goal
Two personal memory goals will be set at baseline and self-reported attainment assessed before and after treatment using Goal Attainment Scaling (GAS). Goal attainment is rated on a 5-point scale from -2 (current level) to +2 (much more than expected). The expected level of goal attainment is scored as 0 by the participant.
Measured: From enrollment to the end of follow up 3 months after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2025
- Study start1 Feb 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acquired Brain Injury (Including Stroke)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital of North Norway
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Martin Kragnes Bystad, University Hospital of North Norway
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06800040
- Sponsor's protocol ID
- REC North ID nr. 793668
- Other IDs
- 38355/HNI0056-24
- Status last verified
- Jan 2025
- First submitted
- 13 Dec 2024
- Last updated
- 22 Jul 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Feasibility and Effectiveness of a Group-Based Memory Rehabilitation Program for Acquired Brain Injury (ABI) Patients
- ClinicalTrials.gov ID
- NCT06800040
- Acronym / sponsor ID
- REC North ID nr. 793668
- Conditions
- Acquired Brain Injury (Including Stroke)
- Keywords
- Memory rehabilitation, Cognitive rehabilitation, Acquired brain injury, Rehabilitation after brain injury
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- University Hospital of North NorwayUniversity, hospital or other
- Study start
- 1 Feb 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2027 (estimated)
- First posted
- 29 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This manualized, group-based memory intervention involves six weekly, two-hour sessions (including a break). Group sizes should be from 3 to 10 participants, as recommended by the developers, with two group leaders (psychologists/neuropsychologists). Each session encompasses education about memory and factors influencing optimal memory function, and training in the use of compensatory memory strategies (both internal strategies and external memory aids). Group exercises and discussions, as well as homework tasks between sessions, are used to facilitate learning and generalisation of memory skills. The two-hour sessions are divided into approximately 15 minutes for reviewing homework and repetition from previous sessions; 20-30 minutes for the educational component; 60-80 minutes for practising strategies and discussing their application; 10 minutes for a break. Full details of the memory intervention, including instructional guidelines, description of exercises, handouts and supporting materials, can be found in the published manual.
The memory training program will constitute a new treatment intervention in the health region of Northern Norway, and the need to carry out feasibility studies as part of the development of complex interventions has been pointed out. Hence, the objective of this study is to identify and evaluate obstacles to delivery and implementation of the program through a feasibility and acceptability study. Effectiveness of the intervention will depend on sufficient feasibility, and will also be evaluated.
The study has two aims. First, the investigators aim to explore the feasibility of delivering the intervention, and the patients acceptability of the intervention, in order to achieve optimal efficacy.
Second, the investigators will explore the effectiveness of the memory training program on participants' memory functioning.
Research question 1 What is the feasibility of the intervention, considering a) the demand for the treatment as assessed through a) Recruitment, b) Adherence, c) Acceptability by participants, and d) Format of delivery.
Research question 2 Does a group-based 6 week memory training program improve objective and subjective memory functioning in individuals with memory complaints after ABI? The aim of the program is to enhance memory functioning on one or more measures of subjective and objective memory, number of memory strategies used in daily life, and/or personal goal attainment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Memory training | Experimental | Behavioral: Memory training |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- history of ABI (stroke/cerebrovascular incidents, traumatic brain injury, anoxia, non-progressive brain tumour, brain infection, or other non-progressive ABI) at least 6 months prior to inclusion.
- memory problems.
- sufficient Norwegian language skills to participate in assessments and group treatment.
- age between 18 and 75 years.
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Memory trainingMemory training | Behavioural | Memory training |
Primary outcome
Feasibility of memory training intervention: Demand for the treatment
Time frame: From enrollment to the end of follow up 3 months after the intervention
The demand for the treatment will be assessed by number of participants enrolled.
Feasibility of memory training intervention: Adherence
Time frame: From enrollment to the end of follow up 3 months after the intervention
Adherence to treatment will be measured by dropout rate.
Feasibility of memory training intervention: Acceptability by participants
Time frame: From enrollment to the end of follow up 3 months after the intervention
Acceptability by participants will be assessed through perceptions of usefulness, measured by responses to evaluation forms.
Feasibility of memory training intervention: Format of delivery
Time frame: From enrollment to the end of follow up 3 months after the intervention
Acceptability of format of delivery (face-to-face and/or telehealth attendance) will be assessed through responses to evaluation forms.
6 secondary outcomes
Memory training effectiveness
Time frame: From enrollment to the end of follow up 3 months after the intervention
Memory training effectiveness
Time frame: From enrollment to the end of follow up 3 months after the intervention
Strategy use
Time frame: From enrollment to the end of follow up 3 months after the intervention
Objective verbal memory functioning
Time frame: From enrollment to the end of follow up 3 months after the intervention
Objective visual memory functioning
Time frame: From enrollment to the end of follow up 3 months after the intervention
Personal memory goal
Time frame: From enrollment to the end of follow up 3 months after the intervention
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Jul 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Memory training in people with Acquired Brain Injury (Including Stroke), run by University Hospital of North Norway at 1 site in Norway.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 22 Jul 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of memory training intervention: Demand for the treatment (time frame: From enrollment to the end of follow up 3 months after the intervention). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Jul 2025.