Testing a Group Memory Training Program for People with Brain Injuries: a Case Study

Not Applicable

• Conditions: Acquired Brain Injury (including Stroke)

• Registration Number: NCT06800040
• Lead Sponsor: University Hospital of North Norway

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.

Study Timeline

• Study First Submitted: 2024-12-13
• Status Verified: 2025-01
• Study First Submitted QC: 2025-01-23
• Last Update Submitted: 2025-01-23
• Study First Posted: 2025-01-29
• Last Update Posted: 2025-01-29
• Study Start: 2025-02-01
• Primary Completion: 2025-12-31
• Study Completion: 2025-12-31

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 15

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Feasibility of memory training intervention: Demand for the treatment	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: Acceptability by participants	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: Adherence	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: Format of delivery	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.

Secondary Outcome Measures

Name	Time	Method
Memory training effectiveness	From enrollment to the end of follow up 3 months after the intervention	Target behaviours for the case series is degree of memory problems in everyday life measured weekly before (3 weeks), during (6 weeks), and after (6 weeks) the intervention 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.
Objective verbal memory functioning	From enrollment to the end of follow up 3 months after the intervention	Memory impairment/objective memory functioning will be assessed with standardised a neuropsychological test of verbal memory (Rey Auditory Verbal Learning Test - RAVLT).
Strategy use	From enrollment to the end of follow up 3 months after the intervention	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.
Objective visual memory functioning	From enrollment to the end of follow up 3 months after the intervention	Memory impairment/objective memory functioning will be assessed with a standardised neuropsychological tests of visual memory (Brief Visuospatial Memory Test-Revised - BVMT-R).
Personal memory goal	From enrollment to the end of follow up 3 months after the intervention	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 (much less than expected) to +2 (much more than expected). The expected level of goal attainment is scored as 0 by the participant.

Trial Locations

Locations (1)

University Hospital of North Norway; 🇳🇴 Tromsø, Norway