Integrated PRocess and StrategieS Training: I-PRESS Training

NCT04882215 | Terminated Results DMC

• 1 other identifier: GN19NE479
• Study Type: interventional
• Target: 14
• Locations: 1 country
• Sites: 1

Brief Summary

There is a pressing need to develop more effective interventions to remediate cognitive deficits in highly prevalent disabling conditions such as stroke, head injury and other forms of acquired brain injury (ABI). Neuropsychological rehabilitation interventions developed in a clinical setting have shown some beneficial effects, but the effectiveness of clinical interventions have potential to be enhanced if informed by findings from cognitive neuroscience. Research into cognitive training using methods such as functional magnetic resonance imaging (fMRI) has contributed to an understanding of factors that promote changes in brain function, but this approach seldom includes individuals with brain damage or cognitive deficits. Its potential for application with clinical populations is therefore uncertain, meaning that people who may benefit do not have access to interventions that may improve their health and wellbeing. The proposed research brings together methods from neuropsychological rehabilitation and cognitive neuroscience to investigate 1) the feasibility of, and effect sizes arising from, combining an existing clinical intervention targeting mental strategies with an adaptive training programme targeting core cognitive processes, and 2) whether the novel treatment combination promotes changes in brain function that are detectable using fMRI. This project will develop and evaluate a training intervention that aims to improve outcomes from a strategy-based rehabilitation intervention, Goal Management Training (GMT), by adding process-based cognitive training with adaptive difficulty to enhance the executive function of working memory updating (WMU). People with ABI (n=32) will complete 9 sessions of GMT, a recommended treatment for deficits in frontal-lobe executive functions, with the addition of 8 WMU training sessions with or without adaptive training. Measures of feasibility, acceptability, and fidelity will be taken, and effect sizes of differences in pre- to post-training changes on neural, cognitive, and functional measurements will be determined by comparing two experimental groups in which difficulty of the WMU training tasks either adaptively increases in response to performance or is fixed.

Conditions

Acquired Brain Injury

Keywords

Traumatic Brain Injury; Stroke; executive dysfunction

Outcome Measures

Primary Outcomes (4)

• Feasibility of Recruitment Process.

  Number of people referred from NHS eligible for screening and those entering the intervention. This will be continuously monitored throughout the study period.

  From pre-intervention (Week 1) to post-intervention (Week 12).

• Participants' Drop-out Rates

  Number of people completing the intervention to assess drop-out rates. This will be continuously monitored throughout the study period.

  From pre-intervention (Week 1) to post-intervention (Week 12).

• Participants' Coherence and Adherence to the Intervention.

  Mean percentage of working memory training sessions completed (a total of eight) were calculated across participants.

  From pre-intervention (Week 1) to post-intervention (Week 12).

• Feedback Questionnaire

  Participant evaluation of the intervention using a study-specific questionnaire including eight 5-point Likert-scale agreement questions (scores of 1 to 5 with 1 being positive and 5 being negative). Mean feedback score was calculated across participants.

  Post-intervention session (Week 12)

Secondary Outcomes (8)

• Visuospatial Working Memory Using the Visuospatial Matrix Updating fMRI Task

  Post-intervention session (week 12)

• Visuospatial Working Memory fMRI Task Accuracy Using the Spatial N-back fMRI Task

  Post-intervention session (Week 12)

• Episodic Visual Memory Accuracy Using the Object-location Association fMRI Task.

  Post-intervention session (Week 12)

• Changes in Shifting Attention Using the Intra-Extra Dimensional Set Shift Test Variant From CANTAB Connect Research Web-testing.

  Pre-intervention (Week 1) and post-intervention (Week 12)

• Changes in Spatial Planning and Problem Solving Using the Stockings of Cambridge Test Variant From CANTAB Connect Research Web-testing.

  Pre-intervention (Week 1) and post-intervention (Week 12)

Study Arms (2)

Adaptive Training (AT)

EXPERIMENTAL

For AT participants, difficulty of the training tasks is progressively increased in response to task performance.

Behavioral: GMT combined with WMU Training

Non Adaptive Training (NA)

ACTIVE COMPARATOR

For NA participants, task difficulty is fixed at a relatively low level across all sessions.

Behavioral: GMT combined with WMU Training

Interventions

GMT combined with WMU Training BEHAVIORAL

GMT teaches the use of mental strategies to support sustained attention during complex (multi-step) task performance following an interactive programme. GMT is structured into nine modules, with interactive discussions and homework assignments. It will be conducted on a group basis. WMU training consists of computerised working memory updating tasks in which trial accuracy and response time are recorded. Two tasks will be trained: 1. a visuo-spatial Matrix Updating (MU) and 2. a verbal Keep Track (KT). For both training tasks, level of difficulty can be modulated by increasing or decreasing the update level, i.e., the number of updates on each trial.

Adaptive Training (AT); Non Adaptive Training (NA)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Only those able to give informed consent and able to comply with the training protocol will be included.
• ≥ 6 months post-ABI at time of recruitment (expression of interest to participate either verbally or in writing)
• Adults over the age of 18.
• English language fluency (speaking)
• a combination of self/relative/friend/carer reports of everyday organisation/memory problems

You may not qualify if:

• Individuals with contra-indications to MRI (e.g. heart pacemaker)
• Comorbid progressive neurological disorder or neurodegenerative condition (e.g. dementia)
• History of major substance abuse problems likely to prevent engagement in the intervention programme
• Unable to give informed consent
• Unable to cooperate with the study protocol (e.g. severe impairment of hearing, vision or language)

Sponsors & Collaborators

• NHS Greater Glasgow and Clyde: lead
• University of Glasgow: collaborator

Study Sites (1)

Lead Communirty Brain Injury Team NHS Lanarkshire Law House Airdrie Road

Carluke, Lanarkshire, ML8 5EP, United Kingdom

Location

Related Publications (13)

• Cicerone KD, Langenbahn DM, Braden C, Malec JF, Kalmar K, Fraas M, Felicetti T, Laatsch L, Harley JP, Bergquist T, Azulay J, Cantor J, Ashman T. Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008. Arch Phys Med Rehabil. 2011 Apr;92(4):519-30. doi: 10.1016/j.apmr.2010.11.015.

  PMID: 21440699 BACKGROUND

• Tornas S, Lovstad M, Solbakk AK, Evans J, Endestad T, Hol PK, Schanke AK, Stubberud J. Rehabilitation of Executive Functions in Patients with Chronic Acquired Brain Injury with Goal Management Training, External Cuing, and Emotional Regulation: A Randomized Controlled Trial. J Int Neuropsychol Soc. 2016 Apr;22(4):436-52. doi: 10.1017/S1355617715001344. Epub 2016 Jan 26.

  PMID: 26812574 BACKGROUND

• Brehmer Y, Kalpouzos G, Wenger E, Lovden M. Plasticity of brain and cognition in older adults. Psychol Res. 2014 Nov;78(6):790-802. doi: 10.1007/s00426-014-0587-z. Epub 2014 Sep 28.

  PMID: 25261907 BACKGROUND

• Constantinidis C, Klingberg T. The neuroscience of working memory capacity and training. Nat Rev Neurosci. 2016 Jul;17(7):438-49. doi: 10.1038/nrn.2016.43. Epub 2016 May 26.

  PMID: 27225070 BACKGROUND

• Klingberg T. Training and plasticity of working memory. Trends Cogn Sci. 2010 Jul;14(7):317-24. doi: 10.1016/j.tics.2010.05.002. Epub 2010 Jun 16.

  PMID: 20630350 BACKGROUND

• Westerberg H, Klingberg T. Changes in cortical activity after training of working memory--a single-subject analysis. Physiol Behav. 2007 Sep 10;92(1-2):186-92. doi: 10.1016/j.physbeh.2007.05.041. Epub 2007 May 21.

  PMID: 17597168 BACKGROUND

• Dahlin E, Neely AS, Larsson A, Backman L, Nyberg L. Transfer of learning after updating training mediated by the striatum. Science. 2008 Jun 13;320(5882):1510-2. doi: 10.1126/science.1155466.

  PMID: 18556560 BACKGROUND

• Dahlin E, Backman L, Neely AS, Nyberg L. Training of the executive component of working memory: subcortical areas mediate transfer effects. Restor Neurol Neurosci. 2009;27(5):405-19. doi: 10.3233/RNN-2009-0492.

  PMID: 19847067 BACKGROUND

• Jaeggi SM, Buschkuehl M, Jonides J, Perrig WJ. Improving fluid intelligence with training on working memory. Proc Natl Acad Sci U S A. 2008 May 13;105(19):6829-33. doi: 10.1073/pnas.0801268105. Epub 2008 Apr 28.

  PMID: 18443283 BACKGROUND

• Buschkuehl M, Hernandez-Garcia L, Jaeggi SM, Bernard JA, Jonides J. Neural effects of short-term training on working memory. Cogn Affect Behav Neurosci. 2014 Mar;14(1):147-60. doi: 10.3758/s13415-013-0244-9.

  PMID: 24496717 BACKGROUND

• Melby-Lervag M, Hulme C. Is working memory training effective? A meta-analytic review. Dev Psychol. 2013 Feb;49(2):270-91. doi: 10.1037/a0028228. Epub 2012 May 21.

  PMID: 22612437 BACKGROUND

• Hsu NS, Novick JM, Jaeggi SM. The development and malleability of executive control abilities. Front Behav Neurosci. 2014 Jun 24;8:221. doi: 10.3389/fnbeh.2014.00221. eCollection 2014.

  PMID: 25071485 BACKGROUND

• Jolles DD, Grol MJ, Van Buchem MA, Rombouts SA, Crone EA. Practice effects in the brain: Changes in cerebral activation after working memory practice depend on task demands. Neuroimage. 2010 Aug 15;52(2):658-68. doi: 10.1016/j.neuroimage.2010.04.028. Epub 2010 Apr 23.

  PMID: 20399274 BACKGROUND

MeSH Terms

Conditions

Brain Injuries; Brain Injuries, Traumatic; Stroke

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Cerebrovascular Disorders; Vascular Diseases; Cardiovascular Diseases

Limitations and Caveats

The study was substantially disrupted by the COVID-19 pandemic. Due to this delay, the project funding supporting the researcher came to an end before finishing the study and therefore failed to hit the recruitment target. For this reason group analysis was not possible, therefore, the data were analysed on a case-study basis. Any group analysis should be interpreted with caution.

Results Point of Contact

• Title: Professor Jonathan Evans
• Organization: University of Glasgow

Jonathan.Evans@glasgow.ac.uk

0141 330 3299

Study Officials

• Jonathan Evans, PhD, DClin

  University of Glasgow

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 26, 2021
• First Posted: May 11, 2021
• Study Start: May 18, 2020
• Primary Completion: August 30, 2022
• Study Completion: October 1, 2023
• Last Updated: November 14, 2024
• Results First Posted: November 14, 2024

Record last verified: 2023-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)