Testing a Group Memory Training Program for People With Brain Injuries

NCT ID: NCT06800040

Last Updated: 2025-07-22

Basic Information

• Recruitment Status: ENROLLING_BY_INVITATION
• Clinical Phase: NA
• Total Enrollment: 20 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-02-01
• Study Completion Date: 2027-12-31

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.

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)

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Memory training

Group Type: EXPERIMENTAL

Memory training

Intervention Type: BEHAVIORAL

Memory training

Interventions

Memory training

Memory training

Intervention Type: BEHAVIORAL

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

University Hospital of North Norway

OTHER

Sponsor Role: lead

Responsible Party

Martin Kragnes Bystad

Head of research

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

University Hospital of North Norway

Tromsø, , Norway

Countries

Norway

Other Identifiers

38355/HNI0056-24

Identifier Type: OTHER

Identifier Source: secondary_id

REC North ID nr. 793668

Identifier Type: -

Identifier Source: org_study_id