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Clinical Trials/NCT01992055
NCT01992055CompletedNot Applicable

Functional Outcomes Following Neuropsychological Intervention in Acquired Brain Injury Outpatients With Executive Dysfunction

University of Manitoba2 sites in 1 country18 target enrollmentStarted: December 2013Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
18
Locations
2
Primary Endpoint
Change from Baseline in neuropsychological functioning at 1 week post-intervention

Study Overview

Brief Summary

This Clinical Trial is a pilot study being conducted to study the impact of a specific cognitive rehabilitation program, Goal Management Training (GMT), in adult patients with executive dysfunction and associated problems in everyday functioning. The intervention program will also include relaxation training and psychoeducation regarding brain injury on everyday functioning, emotional status, and executive functioning. Goal Management Training focuses on teaching individuals strategies to compensate for executive functioning deficits and is based on a theory of goal neglect resulting in disorganized behavior following frontal lobe injury. It emphasizes strategies for self-monitoring and self-evaluation in everyday life. Given its goal-oriented emphasis, focus on individual everyday difficulties, and reports of improvements in self-reported executive failures and mood, GMT appears to be an ideal intervention treatment for individuals with executive and functional deficits.

Given the emphasis of goal-oriented rehabilitation on reducing the impact of cognitive impairment on daily functioning, rather than attempting to restore cognitive abilities, a reduction in subjective reports of psychological distress is anticipated. This hypothesis is consistent with existing literature revealing reduced reports of annoyance and executive difficulties on self-report inventories. Improvements on tests of sustained attention and visuospatial problem-solving, as well as small effects on additional measures of planning, are also anticipated.

Detailed Description

Executive functions (EF) are higher-order cognitive processes used particularly under novel and complex conditions (Shallice, 1990) and comprise various abilities including devising goals, elucidating alternative solutions, implementing goal-directed behaviors, self-monitoring, and behavior modification and perseverance (Snyder, Nussbaum, & Robins, 2009). According to Sohlberg and Mateer (2001; p.234), EF may be described as cognitive abilities "required to complete goal-directed [behavior] that is not overlearned, automatic, and routine." As a result, executive dysfunction can impair one's ability to function independently (Bolognani et al., 2007). Research has identified a positive relationship between functional ability and EF (Hanks, Rapport, Millis, & Deshpande, 1999). Additionally, differential declines in EF are observed in normal aging after the age of 60 years (Treitz, Heyder, & Daum, 2007). As well, the profile of cognitive impairment in Parkinson's disease is marked by a predominance of executive dysfunction, followed by memory deficits (Emre, 2003; Emre, 2004; Verbaan et al, 2007). In addition to traumatic and acquired brain injuries, executive dysfunction and functional deficits have been observed in individuals with psychiatric illnesses such as ADHD (Attention Deficit Hyperactivity Disorder; e.g., Willcutt, Doyle, Nigg, Faraone, & Pennington, 2005), psychostimulant and opioid abuse (e.g., Verdejo-Garcıa, Lopez-Torrecillas, Aguilar de Arcos, & Perez-Garcıa, 2005; Fernández-Serranoa, Pérez-García, & Verdejo-García, 2011), bipolar disorder (e.g., Frangou, Donaldson, Hadjulis, Landay, & Goldstein, 2005; Maalouf et al., 2010), and geriatric depression (Lockwood, Alexopoulos, van Gorp, 2002). The prominence of executive dysfunction in individuals with acquired brain injury and mental illness, and the associated costs on the healthcare system, highlights a role for cognitive rehabilitation.

Cognitive rehabilitation refers to interventions aiming to enhance or support cognitive abilities following brain injury, with an emphasis on achieving functional changes. It is a structured, goal-oriented, collaborative process between the therapist and the patient (and, where possible, caregivers/family) and is informed by medical and neuropsychological data (Sohlberg & Mateer, 2001). A recent meta-analysis of the effectiveness of cognitive rehabilitation following acquired brain injury revealed a significant effect on global cognitive functioning, with time-since-injury acting as a moderating variable. Attention training following traumatic brain injury (TBI) and language and visuospatial training for aphasia were identified as effective treatments (Rohling, Faust, Beverly, & Damaskis, 2009). In their review of intervention approaches for executive dysfunction, Boelen, Spikman, and Fasotti (2011) describe three approaches used in previous studies. First, compensatory strategies emphasize teaching patients cognitive strategies to offset cognitive deficits. Second, restorative strategies aim to repair cognitive functions. Third, behavioral therapy interventions seek to modify behavior through means such as token economies.

An example of the compensatory approach to executive dysfunction is Goal Management Training (GMT). GMT is a cognitive rehabilitation strategy based on Duncan's (1986) theory of goal neglect resulting in disorganized behavior following frontal lobe injury. It emphasizes strategies for self-monitoring and self-evaluation in everyday life, including pausing, identifying the task at hand, outlining the goals and listing the required steps, completing the task, and evaluating the successful completion of the task.

Given the relationship between disorganized behavior and functional dependence, the use of GMT in patients with executive dysfunction is highly relevant. Levine et al. (2000) compared the effectiveness of GMT and motor skills training (MST) in patients with TBI who were living independently in the community. The GMT group exhibited improved performance on paper and pencil tasks (e.g., proofreading) and slowed speed of task completion suggested increased attention to task demands. Improvements on the MST trained tasks were noted for the MST group. Fish and colleagues (2007) evaluated the effect of a "content-free" cueing strategy (i.e., text messages reading STOP!), the first stage in GMT, to compensate for goal-neglect following brain injury. The authors reported significant improvements in goal-directed behavior with the addition of "content free" cues and conclude that the provision of cues improves goal management by increasing self-monitoring.

GMT has also been evaluated in normal aging, given the relationship between reduced executive functioning, functional difficulties, and aging. Van Hooren and colleagues (2007) evaluated 69 Dutch adults aged 55 years or older for the impact of a structured 12-session GMT program on cognitive functioning, self-reported mood, and self-reported cognitive complaints and failures. Their GMT program included psychoeducation regarding cognitive functioning and functional difficulties and their study design utilized a randomized wait-list control group. The results revealed reduced annoyance, improved management of cognitive failures, and decreased anxiety in the treatment group, relative to controls. No improvement on objective measures of cognitive functioning was noted. In another wait-list controlled study evaluating GMT in normal aging, Levine and colleagues (2007) reported decreased self-report of executive failures and improved performance on simulated real-life tasks in 49 healthy older adults.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Treatment
Masking
None

Eligibility Criteria

Ages
18 Years to 65 Years (Adult, Older Adult)
Sex
All
Accepts Healthy Volunteers
No

Inclusion Criteria

  • Participants may be included in the study if they are identified as having EF impairments, secondary to an acquired brain injury, and are between the ages of 18 and 65 years. Informed consent will be gathered from each participant. Eligible participants will be informed about the purpose of the study, the associated risks and benefits, and their option to withdraw from the study at any time without penalty. Potential risks include subtle discomfort when initially participating in relaxation exercises, which typically resolves with familiarity, and mild distress during neuropsychological assessment. These issues sometimes arise during standard clinical practice and the neuropsychologists involved are experienced in assisting people in reducing their distress.

Exclusion Criteria

  • Individuals with significant memory impairment, receptive language deficits, active psychosis, severe depression (i.e., Beck Depression Inventory - II [BDI-II] ≥ 30), or a diagnosis of dementia will be excluded from participating in the study.. A minimum of 36 participants will be recruited for this study.

Arms & Interventions

Goal Management Training

Experimental

The modified GMT intervention will consist of seven group sessions and, similar to van Hooren et al (2007), an individual session with a neuropsychologist on Session 5. Sessions will be held twice weekly. The manualized group sessions will include: (1) structured psychoeducation introducing participants to the brain and executive functioning, the relationship between stress and cognitive functioning, and relaxation training; (2) stepwise learning of GMT, including education regarding attentional lapses and goal neglect, as well as in-session practice targeting individual everyday functional deficits with the goal of maximizing generalization. Homework assignments targeting individual functional deficits will be assigned following each session.

Intervention: Goal Management Training (Behavioral)

Education & relaxation training

Active Comparator

Education and relaxation training control group

Intervention: Education & relaxation training (Behavioral)

Outcomes

Primary Outcomes

Change from Baseline in neuropsychological functioning at 1 week post-intervention

Time Frame: 1 week post-intervention

Change in test scores on the following measures: Connor's Continuous Performance Test - II Delis-Kaplan Executive Functioning Scale Tower Test Trail Making Test Ruff Figural Fluency Test Controlled Oral Word Association Test Semantic Fluency Golden's Stroop Color and Word Test BADS Six Elements Test Brief-A Self and Family Report Inventories SCL-90-R Self-Report Inventory Word Memory Test Medical Symptom Validity Test (MSVT) Non-Verbal MSVT

Secondary Outcomes

  • Change from Baseline in neuropsychological functioning at 4 weeks post-intervention(4 weeks post-intervention)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Dr. Lesley Ritchie

Assistant Professor/Neuropsychologist

University of Manitoba

Study Sites (2)

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