Outcomes Following Neuropsychological Intervention in Acquired Brain Injury Outpatients With Executive Dysfunction
Condition: Acquired Brain Injury
MeSH terms: Brain Injuries; Wounds and Injuries
Study type: Interventional

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.

      In addition to group studies, GMT has been evaluated in single case studies. Schweizer et al
      (2008) provided seven, weekly, two-hour sessions of GMT to a patient with focal damage to the
      cerebellum. Evaluation of the treatment included pre-, post-, and long-term (i.e., 4 months
      post-intervention) administration of attention, executive functioning, and self-report
      measures. Although modest improvements on objective measures of executive functioning were
      observed, the patient endorsed significant improvements in functional abilities (i.e., return
      to work). Similarly, Levine and colleagues (2000) observed improvements in meal preparation,
      following two sessions of GMT, in a patient in the chronic stage of recovery from
      meningo-encephalitis. The GMT sessions focused on the five stages of GMT using the patient's
      recipes as training examples. The effect of GMT on meal preparation was maintained at a
      six-month follow-up evaluation.

      Recently, the first controlled, partially randomized, study of GMT was completed with
      patients in the chronic stage of recovery from a focal brain injury and who were exhibiting
      persistent executive dysfunction (Levine et al., 2011). Significant improvements in sustained
      attention, behavioral consistency, and problem-solving were reported for the GMT group, with
      no significant effects found for the control group. However, in contrast to previous studies
      (Levine et al., 2007; van Hooren et al., 2007), no change on self-report measures of everyday
      executive functioning was observed. The authors attribute the lack of change in subjective
      report to two possible factors: 1) an absence of collateral ratings and 2) reduced insight
      due to executive dysfunction or improved insight resulting in increased item endorsement. The
      authors conclude that GMT is an effective intervention for executive dysfunction, which
      produces improvements in both trained and untrained behaviors.

      Goal management training has been described as a unique cognitive rehabilitation technique,
      given its theoretical basis in goal neglect following frontal lobe damage and its emphasis on
      real-life behaviors (Levine et al., 2000). The authors also reveal that, for rehabilitation
      strategies to generalize to other behaviors, generalization must be a component of the
      intervention itself. This conclusion is consistent with Sohlberg and Mateer's (2001)
      suggestion that clinicians should "program generalization" by training overlearning and
      general strategies for various locations and tasks, emphasizing individual difficulties,
      incorporating significant others in the rehabilitation process, and planning for obstacles.
      It has been recommended that rehabilitation for executive dysfunction emphasize the
      achievement of independence in functional activities and generalization to everyday
      activities (Boelen, Spikman, & Fasotti, 2011). 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 for individuals with functional
      and executive function impairment.

      OBJECTIVES

      The purpose of the proposed study is to evaluate the effectiveness of a GMT group,
      emphasizing compensatory strategies for executive dysfunction (e.g., goal neglect and
      attentional lapses), as well as relaxation training and psychoeducation regarding brain
      injury, in a sample of adult outpatients with identified executive dysfunction and associated
      functional deficits. Specific objectives include:

        1. Evaluation of the short-term efficacy of GMT on self- and collateral-report of everyday
           functioning.

        2. Evaluation of the short-term efficacy of GMT on neuropsychological outcome measures.

        3. Evaluation of the long-term (i.e., 1 year) efficacy of GMT on self- and
           collateral-report of everyday functioning.

        4. Identification of neuropsychological measures sensitive to cognitive change following
           GMT, through the use of a more extensive battery of neuropsychological tests, compared
           to previous studies.

        5. Evaluation of the long-term (i.e., 1 year) efficacy of GMT on neuropsychological outcome
           measures.

        6. Identify the primary mediator of change in GMT by comparing a control group receiving
           two sessions of relaxation training and psychoeducation relative to a treatment group
           receiving the complete GMT program (including relaxation training and psychoeducation).

      HYPOTHESES 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 (van Hooren et al., 2007; Levine et al.,
      2007). Previous research has identified improvement on sustained attention and visuospatial
      problem-solving tasks following GMT (Levine et al., 2011). The proposed battery of
      neuropsychological tests includes a greater number of neuropsychological measures evaluating
      different neuropsychological functions. Improvements on tests of sustained attention and
      visuospatial problem-solving, as well as small effects on additional measures of planning,
      are also anticipated.

      METHODOLOGY Participants Group Assignment Participants will be randomly assigned to a GMT
      Treatment or Control Group. The GMT cognitive rehabilitation intervention program will be
      administered in group format, consisting of 8 sessions, including structured psychoeducation,
      relaxation training, and stepwise learning of GMT. The Control Group program will also be
      administered in group format, consisting of two sessions, including structured
      psychoeducation and relaxation training. Participants assigned to the Control condition will
      be offered the opportunity to complete the full GMT program following the completion of the
      study.

      Intake: A screening interview with the patient and their significant other will be conducted
      to gather essential background demographic and medical information, including self- and
      collateral-report of cognitive, emotional, and functional status. Participants referred
      without a baseline neuropsychological assessment will undergo a standardized
      neuropsychological battery. For patients referred with a brief cognitive screen, additional
      neuropsychological measures will be administered.

      GMT Treatment Group: A modified (i.e., including psychoeducation and relaxation training) GMT
      cognitive rehabilitation intervention program will be administered in group format. Each
      group will consist of six participants to ensure sufficient time to address both group and
      individual functional difficulties. Although more cost-effective, larger groups of patients
      with executive dysfunction are not planned, given the prominence of organizational and
      attention deficits among patients with executive dysfunction. 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.

      Control Group: Participants randomly assigned to the Control condition will participate in
      two group sessions emphasizing psychoeducation and relaxation training. The proposed Control
      condition goes beyond the current standard of care, which does not include any cognitive or
      psychological intervention beyond neuropsychological and medical assessment. In keeping with
      the GMT Treatment group, the Control groups will consist of six participants. Sessions will
      be scheduled along side the GMT Treatment sessions (i.e., two sessions in one week)
    

Intervention name(s): Goal Management Training; Education & relaxation training
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Participants will be randomly assigned to the GMT Treatment. The GMT cognitive rehabilitation intervention program will be administered in group format, consisting of 8 sessions, including structured psychoeducation, relaxation training, and stepwise learning of GMT.; The Education & Relaxation Training Control Group program will also be administered in group format, consisting of two sessions, including structured psychoeducation and relaxation training. Participants assigned to the Control condition will be offered the opportunity to complete the full GMT program following the completion of the study.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Executive dysfunction; Neuropsychological rehabilitation; Goal Management Training