Clinical trial NCT06800040: Testing a Group Memory Training Program for People with Brain Injuries: a Case Study
Official title: Evaluating the Feasibility and Effectiveness of a Group-Based Memory Rehabilitation Program for Acquired Brain Injury (ABI) Patients: a Single-Case Series Design
Study type: INTERVENTIONAL
Overall status: ENROLLING_BY_INVITATION
Phase: NA
Conditions: Acquired Brain Injury (including Stroke)
Keywords: Memory rehabilitation
Cognitive rehabilitation
Acquired brain injury
Rehabilitation after brain injury
Lead sponsor: University Hospital of North Norway
Sponsor class: OTHER
First posted: 2025-01-29
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Case-series
Primary purpose: TREATMENT

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 three groups will be run during 2025. One of the three groups will be partly 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 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.

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

Primary outcomes:
measure: Feasibility of memory training intervention: Demand for the treatment
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Feasibility of memory training intervention: Adherence
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Feasibility of memory training intervention: Acceptability by participants
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Feasibility of memory training intervention: Format of delivery
timeFrame: From enrollment to the end of follow up 3 months after the intervention
Secondary outcomes:
measure: Memory training effectiveness
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Memory training effectiveness
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Strategy use
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Objective verbal memory functioning
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Objective visual memory functioning
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Personal memory goal
timeFrame: From enrollment to the end of follow up 3 months after the intervention
Other outcomes:
measure: Objective attention functioning
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Emotional symptoms/distress
timeFrame: From enrollment to the end of follow up 3 months after the intervention
measure: Emotional Well-being
timeFrame: From enrollment to the end of follow up 3 months after the intervention
Locations:
city: Tromsø
country: Norway
facility: University Hospital of North Norway
Study officials:
References: