Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder
Condition: Major Depressive Disorder; Post-traumatic Stress Disorder
MeSH terms: Depressive Disorder; Depression; Depressive Disorder, Major; Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic
Study type: Interventional

Summary: 
      Individuals with affective disorders (including post-traumatic stress disorder (PTSD) and
      major depressive disorder (MDD)) often experience declines in cognitive abilities such as
      memory and attention. Such difficulties can reduce functioning in important aspects of life,
      including at work or school. Little research has been conducted to investigate if cognitive
      dysfunction can be reduced in individuals with PTSD or MDD following a specific treatment.
      Thus, the investigators plan to determine the utility of a cognitive training program called
      goal management training (GMT) in reducing cognitive dysfunction in MDD/PTSD. GMT aims to
      assist participants in building skills in performing specific behaviours that rely on basic
      cognitive processes, allowing them to achieve an identified goal. 64 individuals with PTSD
      and 64 with MDD will be divided into two groups of 32, one GMT group, and one wait-list group
      that will receive GMT after study completion. The investigators predict that in comparison to
      the wait-list group, the GMT group will show greater improvements in cognitive functioning
      and everyday functioning following treatment and that these improvements will remain
      long-term.
    

Detailed description: 
      In addition to their core affective components, MDD and PTSD are associated with poor
      cognitive functioning across a host of highly similar domains, including declarative memory,
      short-term memory, attention, and executive functioning. These deficits have been associated
      with reduced response to pharmacological and non-pharmacological interventions and poor
      functional outcomes. Given the potentially devastating impact of poor cognitive functioning
      on the ability of patients with affective disorders to benefit from treatment interventions,
      and its association with poor functional outcomes, there is an urgent need to identify novel
      treatment interventions aimed at reducing cognitive dysfunction in these disorders.
      Accordingly, the aim of the present proposal is to a randomized controlled trial examining
      the efficacy of a well-established cognitive intervention aimed at reducing attentional and
      executive dysfunction, Goal Management Training® (GMT), in the treatment of cognitive
      deficits among patients with MDD and with PTSD. A secondary aim is to determine the
      longer-term impact of this approach on functional outcomes.

      Importantly, limited investigation of cognitive remediation therapy has been performed in
      these populations. Only one study has been conducted to examine the impact of a
      non-standardized intervention protocol aimed at improving cognitive functioning in PTSD.
      Here, clinically (but not statistically) significant improvements were noted in a small pilot
      study on measures of cognitive functioning after employing bottom-up executive training
      approach in conjunction with transcranial direct current sample of four patients. Previously,
      the investigators have applied computer-assisted cognitive remediation, a bottom-up
      restitution based approach, in patients with MDD, resulting in improvements in performance on
      working memory tasks in conjunction with increased functional activity in lateral prefrontal
      and parietal areas, however, the broad benefits of this training observed in a small sample
      (n=12) did not generalize to a larger group.

      GMT has demonstrated efficacy in several clinical and non-clinical populations that
      experience deficits in executive functioning, attention, and memory (similar to those seen in
      MDD and PTSD), including older adults, individuals who have suffered a traumatic brain
      injury, have attention-deficit hyperactivity disorder (ADHD), poly-substance abuse disorder,
      or spina bifida. In these studies, participants showed improvements in completing every-day
      tasks (as measured by self-report), as well as improvements in executive functions such as
      decision-making, working memory and selective attention. Critically, these results were
      maintained at follow-up (when assessed). Given the previous success of this intervention in
      remediating frontal-temporally mediated brain dysfunction across clinical populations, the
      investigators hypothesize that GMT has the ability to target similar cognitive difficulties
      experienced by those suffering from MDD and from PTSD. The investigators will further examine
      whether putative improvements in cognitive performance will translate to functional
      improvements analogous to those seen in other psychiatric populations undergoing cognitive
      remediation.

      In the current study, the investigators will conduct the first study to investigate the
      utility of GMT in patients with MDD or with PTSD. Specifically, the primary aim of this
      proposed study is to examine whether a standardized 9-week program of GMT results in durable
      improvements in cognitive functioning relative to a wait-list control (WLC). A secondary aim
      will be to determine whether participation in the GMT group is associated with long-term
      functional improvements. The investigators hypothesize that at post-treatment, participants
      with MDD and with PTSD assigned to the GMT groups will show significantly greater improvement
      in neuropsychological test performance and greater functional improvement compared to
      participants in the WLC group; these gains are expected to be maintained at 3 month
      follow-up.
    

Intervention name(s): Goal Management Training
Intervention type(s): Behavioral
Intervention description(s): Goal management training sessions will be 2 hours in length and focus on learning skills that will assist in planning, carrying out, and monitoring goal-directed behaviours.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: Cognitive Remediation; Goal Management Training; Major Depressive Disorder; Post-traumatic Stress Disorder; Neuropsychological Functioning