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      The efficacy of prospective memory rehabilitation plus metacognitive skills training for adults with traumatic brain injury: study protocol for a randomized controlled trial

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          Abstract

          Background

          Impairment of prospective memory (PM) is common following traumatic brain injury (TBI) and negatively impacts on independent living. Compensatory approaches to PM rehabilitation have been found to minimize the impact of PM impairment in adults with TBI; however, poor self-awareness after TBI poses a major barrier to the generalization of compensatory strategies in daily life. Metacognitive skills training (MST) is a cognitive rehabilitation approach that aims to facilitate the development of self-awareness in adults with TBI. This paper describes the protocol of a study that aims to evaluate the efficacy of a MST approach to compensatory PM rehabilitation for improving everyday PM performance and psychosocial outcomes after TBI.

          Methods/design

          This randomized controlled trial has three treatment groups: compensatory training plus metacognitive skills training (COMP-MST), compensatory training only (COMP), and waitlist control. Participants in the COMP-MST and COMP groups will complete a 6-week intervention consisting of six 2-h weekly training sessions. Each 1.5-h session will involve compensatory strategy training and 0.5 h will incorporate either MST (COMP-MST group) or filler activity as an active control (COMP group). Participants in the waitlist group receive care as usual for 6 weeks, followed by the COMP-MST intervention. Based on the sample size estimate, 90 participants with moderate to severe TBI will be randomized into the three groups using a stratified sampling approach. The primary outcomes include measures of PM performance in everyday life and level of psychosocial reintegration. Secondary outcomes include measures of PM function on psychometric testing, strategy use, self-awareness, and level of support needs following TBI. Blinded assessments will be conducted pre and post intervention, and at 3-month and 6-month follow-ups.

          Discussion

          This study seeks to determine the efficacy of COMP-MST for improving and maintaining everyday PM performance and level of psychosocial integration in adults with moderate to severe TBI. The findings will advance theoretical understanding of the role of self-awareness in compensatory PM rehabilitation and skills generalization. COMP-MST has the potential to reduce the cost of rehabilitation and lifestyle support following TBI because the intervention could enhance generalization success and lifelong application of PM compensatory strategies.

          Trial registration

          New Zealand Clinical Trials Registry, ACTRN12615000996561. Registered on 23 September 2015; retrospectively registered 2 months after commencement.

          Electronic supplementary material

          The online version of this article (doi:10.1186/s13063-016-1758-6) contains supplementary material, which is available to authorized users.

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          Most cited references46

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          Evidence-based cognitive rehabilitation: updated review of the literature from 2003 through 2008.

          To update our clinical recommendations for cognitive rehabilitation of people with traumatic brain injury (TBI) and stroke, based on a systematic review of the literature from 2003 through 2008. PubMed and Infotrieve literature searches were conducted using the terms attention, awareness, cognitive, communication, executive, language, memory, perception, problem solving, and/or reasoning combined with each of the following terms: rehabilitation, remediation, and training for articles published between 2003 and 2008. The task force initially identified citations for 198 published articles. One hundred forty-one articles were selected for inclusion after our initial screening. Twenty-nine studies were excluded after further detailed review. Excluded articles included 4 descriptive studies without data, 6 nontreatment studies, 7 experimental manipulations, 6 reviews, 1 single case study not related to TBI or stroke, 2 articles where the intervention was provided to caretakers, 1 article redacted by the journal, and 2 reanalyses of prior publications. We fully reviewed and evaluated 112 studies. Articles were assigned to 1 of 6 categories reflecting the primary area of intervention: attention; vision and visuospatial functioning; language and communication skills; memory; executive functioning, problem solving and awareness; and comprehensive-holistic cognitive rehabilitation. Articles were abstracted and levels of evidence determined using specific criteria. Of the 112 studies, 14 were rated as class I, 5 as class Ia, 11 as class II, and 82 as class III. Evidence within each area of intervention was synthesized and recommendations for Practice Standards, Practice Guidelines, and Practice Options were made. There is substantial evidence to support interventions for attention, memory, social communication skills, executive function, and for comprehensive-holistic neuropsychologic rehabilitation after TBI. Evidence supports visuospatial rehabilitation after right hemisphere stroke, and interventions for aphasia and apraxia after left hemisphere stroke. Together with our prior reviews, we have evaluated a total of 370 interventions, including 65 class I or Ia studies. There is now sufficient information to support evidence-based protocols and implement empirically-supported treatments for cognitive disability after TBI and stroke. Copyright © 2011 American Congress of Rehabilitation Medicine. Published by Elsevier Inc. All rights reserved.
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            The assessment, monitoring, and enhancement of treatment fidelity in public health clinical trials.

            To discuss methods of preservation of treatment fidelity in health behavior change trials conducted in public health contexts. The treatment fidelity framework provided by the National Institutes of Health's Behavioral Change Consortium includes five domains of treatment fidelity (Study Design, Training, Delivery, Receipt, and Enactment). A measure of treatment fidelity was previously developed and validated using these categories. Strategies for assessment, monitoring, and enhancing treatment fidelity within each of the five treatment fidelity domains are discussed. The previously created measure of treatment fidelity is updated to include additional items on selecting providers, additional confounders, theory testing, and multicultural considerations. Implementation of a treatment fidelity plan may require extra staff time and costs. However, the economic and scientific costs of lack of attention to treatment fidelity are far greater than the costs of treatment fidelity implementation. Maintaining high levels of treatment fidelity with flexible adaptation according to setting, provider, and patient is the goal for public health trials.
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              The effect of moderate to severe traumatic brain injury (TBI) on different aspects of memory: a selective review.

              Eli Vakil (2005)
              Deficient learning and memory are frequently reported as a consequence of traumatic brain injury (TBI). Because of the diffuse nature of the injury, patients with TBI are not the ideal group for studying brain-behavior relations. Nevertheless, characterization of the memory breakdown following TBI could contribute to the assessment and rehabilitation of this patient population. It is well documented that memory is not a unitary system. Accordingly, in this article I review studies that have investigated the long-term effect of moderate to severe TBI on different memory aspects, including explicit and implicit tests of memory. This review demonstrates that TBI affects a large range of memory aspects. One of the conclusions is that the memory impairment observed in TBI patients could be viewed, at least to some degree, as a consequence of a more general cognitive deficit. Thus, unlike patients suffering from global amnesia, memory in patients with TBI is not selectively impaired. Nevertheless, it is possible to detect a subgroup of patients that do meet the criteria of amnesia. However, the most common vulnerable memory processes following TBI very much resemble the memory deficits reported in patients following frontal lobe damage, e.g., difficulties in applying active or effortful strategy in the learning or retrieval process. The suggested similarity between patients with TBI and those suffering from frontal lobe injury should be viewed cautiously; considering the nature of TBI, patients suffering from such injuries are not a homogeneous group. In view of this limitation, the future challenge in this field will be to identify subgroups of patients, either a priori according to a range of factors such as severity of injury, or a posteriori based on their specific memory deficit characteristics. Such a research approach has the potential of explaining much of the variability in findings reported in the literature on the effect of TBI on memory.
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                Author and article information

                Contributors
                j.fleming@uq.edu.au
                t.ownsworth@griffith.edu.au
                e.doig@uq.edu.au
                lauren.hutton3@griffithuni.edu.au
                janelle.griffin@health.qld.gov.au
                melissa.kendall@health.qld.gov.au
                d.shum@griffith.edu.au
                Journal
                Trials
                Trials
                Trials
                BioMed Central (London )
                1745-6215
                5 January 2017
                5 January 2017
                2017
                : 18
                : 3
                Affiliations
                [1 ]School of Health and Rehabilitation Sciences, University of Queensland, Brisbane, 4072 QLD Australia
                [2 ]Menzies Health Institute Queensland and School of Applied Psychology, Griffith Health Institute, Griffith University, Mount Gravatt, QLD Australia
                [3 ]Occupational Therapy Department, Princess Alexandra Hospital, Brisbane, Australia
                [4 ]Acquired Brain Injury Outreach Service, Princess Alexandra Hospital, Metro South Hospital and Health Service, Woolloongabba, QLD Australia
                [5 ]Menzies Health Institute Queensland and School of Human Services and Social Work, Griffith University, Meadowbrook, QLD Australia
                Author information
                http://orcid.org/0000-0002-5603-2410
                Article
                1758
                10.1186/s13063-016-1758-6
                5217156
                28057075
                2fd00eac-2bf5-44e8-9004-317c5084a75b
                © The Author(s). 2017

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 14 September 2016
                : 15 December 2016
                Funding
                Funded by: FundRef http://dx.doi.org/10.13039/501100000925, National Health and Medical Research Council;
                Award ID: PG1083064
                Award Recipient :
                Categories
                Study Protocol
                Custom metadata
                © The Author(s) 2017

                Medicine
                brain injury,prospective memory,self-awareness,rehabilitation,randomized controlled trial
                Medicine
                brain injury, prospective memory, self-awareness, rehabilitation, randomized controlled trial

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