Abstract
BackgroundWe have been investigating an ecologically valid strategy-training approach to enable adults with executive dysfunction to attain everyday life goals. Here, we report the protocol of a randomized controlled trial of the effects of this training compared to conventional therapy in a sample of community-dwelling adults with acquired brain injury and/or stroke.Methods/designWe will recruit 100 community-dwelling survivors at least six months post-acquired brain injury or stroke who report executive dysfunction during a telephone interview, confirmed in pre-training testing. Following pre-training testing, participants will be randomized to the ecologically valid strategy training or conventional therapy and receive two one-hour sessions for eight weeks (maximum of 15 hours of therapy). Post-testing will occur immediately following the training and three months later. The primary outcome is self-reported change in performance on everyday life activities measured using the Canadian Occupational Performance Measure, a standardized, semi-structured interview. Secondary outcomes are objective measurement of performance change from videotapes of treatment session, Performance Quality Rating Scale; executive dysfunction symptoms, Behavioural Rating Inventory of Executive Function – Adult; participation in everyday life, Mayo-Portland Adaptability Inventory Participation Index; and ability to solve novel problems, Instrumental Activities of Daily Living Profile.DiscussionThis study is of a novel approach to promoting improvements in attainment of everyday life goals through managing executive dysfunction using an ecologically valid strategy training approach, the Cognitive Orientation to daily Occupational Performance. This study compares the efficacy of this approach with that of conventional therapy. The approach has the potential to be a valuable treatment for people with chronic acquired brain injury and/or stroke.Trial registrationclinicaltrials.gov, Trial Identification Number: NCT01414348
Highlights
We have been investigating an ecologically valid strategy-training approach to enable adults with executive dysfunction to attain everyday life goals
This study is of a novel approach to promoting improvements in attainment of everyday life goals through managing executive dysfunction using an ecologically valid strategy training approach, the Cognitive Orientation to daily Occupational Performance
The approach has the potential to be a valuable treatment for people with chronic acquired brain injury and/or stroke
Summary
This paper describes the protocol for testing the efficacy of an ecologically valid approach to managing executive dysfunction. We hypothesize that participants trained in the adapted CO-OP approach and their significant others will report and demonstrate significantly more improvement on self-identified difficulties in everyday life than participants receiving conventional therapy. We hypothesize that the strategies learned by participants receiving the CO-OP training will be applied in other areas of everyday life, will be reported by participants and their significant others and observed on measures of the impact of executive dysfunction in everyday life and on overall community integration. Authors’ contributions DD, NA, MB, CB, TD, HP, and MZ participated in the conception and design of the trial and in plans for the analysis of the data. DD, HP, and AH participated in the design of the experimental intervention. All authors commented critically on the manuscript and approved the protocol for publication
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