The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Improving Every-day Functioning in Individuals With Affective Disorders
Condition: Post-traumatic Stress Disorder; Cognitive Dysfunction
MeSH terms: Stress Disorders, Traumatic; Stress Disorders, Post-Traumatic; Cognitive Dysfunction; Mood Disorders
Study type: Interventional

Summary: 
      This study investigates the utility of Goal Management Training (GMT) in patients with
      post-traumatic stress disorder (PTSD), in order to determine if this treatment is effective
      in improving cognitive function in patients with frontal-temporally mediated brain
      dysfunction. Specifically, the primary aim of this 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 group. A secondary aim will be to determine whether participation in the
      GMT group is associated with long-term functional improvements. It is hypothesized that at
      post-treatment, participants with PTSD assigned to the GMT groups will show greater
      improvement in neuropsychological test performance and greater functional improvement
      compared to those in the wait-list group; these gains are expected to be maintained at 3
      month follow-up.
    

Detailed description: 
      Given the potentially devastating impact of poor cognitive functioning on the ability of
      patients with PTSD 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 conduct a randomized controlled trial among patients with PTSD, examining the
      efficacy of a well-established cognitive intervention (in the treatment of cognitive
      deficits), aimed at reducing attentional and executive dysfunction, known as Goal Management
      Training® (GMT) (See Levine et al., 2011). A secondary aim is to determine the longer-term
      impact of the GMT approach on functional outcomes.

      The participants include 48 men and women with a primary diagnosis of with stable symptoms at
      the time of baseline assessment and reporting alterations in memory, attention, or executive
      functioning. Participants will be recruited from multiple sites: an inpatient post-traumatic
      stress recovery program in Ontario, Canada, and the program's external referral agencies that
      also service clients via outpatient services/ programs, external community agencies and
      support groups, and through social media.

      Following determination of eligibility, participants will be randomly assigned, by using the
      randomized table of numbers method, to either: 1) a 9-week GMT program or 2) a 9-week
      wait-list control (WLC) condition (see Figure 1). Participants will be invited to attend a
      baseline testing session 1 prior to group commencement (approximately 4 hours in duration)
      where written consent will be obtained prior to any collection of data. Once the testing
      session is complete, the participants will be given information about what group they have
      been assigned to (GMT or WLC).

      Participants enrolled in the GMT program attended the 9-week GMT sessions (2 hours/week for 9
      weeks) and a post-intervention testing session date (1-2 weeks following the completion of
      the GMT; approximately 3 hours in duration). Participants enrolled in the WLC control group
      attended a testing session date after 9 weeks has past (approximately 3 hours in duration).

      As each participant completed a post-intervention testing session (both GMT and WLC), they
      will be setup with the final testing session (in 3 months' time; approximately 3 hours in
      duration). WLC were offered a complimentary 9-week GMT program once the final testing session
      is complete. Following the completion of the complimentary 9-week GMT program, individuals in
      the WLC completed a post-intervention testing (1-2 weeks following the completion of GMT and
      again at 3 months, post GMT completion).

      These data will be analyzed using 2 x 3 mixed-design split plot factorial ANCOVAs that treat
      Group (GMT vs. WLC) as a between-subjects factor and Time (baseline, post-intervention, 3
      months; subjects nested within groups) as a within-subjects factor. In addition,
      within-subjects analyses of covariance (ANCOVAS) treating time (baseline, post-intervention,
      3 months) as a within-subjects factor will be carried out on data collected from the GMT
      group and from the WLC group after they have completed the GMT arm of the study. PTSD symptom
      severity (CAPS), depressive symptom severity (BDI-II), severity of past trauma exposure
      (CTQ), and medication load, and additional psychological treatment (treatment information
      form) will serve as covariates in this model. Tukey's Honestly Significant Difference
      post-hoc test will be used for follow-up pair-wise comparisons of between-subjects'
      variables.

      It is hypothesized that, post-treatment, participants with PTSD assigned to the GMT group
      will show significantly greater improvement in neuropsychological test performance and
      greater functional improvement compared to participants in the wait-list control 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 Therapy is a structured, short-term, present-oriented cognitive remediation program with emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train patients to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments.
Allocation: Randomized
Intervention model: Parallel Assignment
Intervention model description: Participants will be randomly assigned to either: 1) a 9-week GMT program or 2) a 9-week wait-list control (WLC) condition. Participants will be tested at baseline prior to group commencement. Once the testing session is complete, the participants will be assigned to (GMT or WLC). Participants enrolled in the GMT program will attend 9-weeks of GMT sessions (2 hours/week for 9 weeks) and a post-intervention testing session date. Participants enrolled in the WLC group will be given a testing session date after 9 weeks has past. Participants will attend a final testing session (in 3 months' time; approximately 3 hours in duration). WLC will be offered a complimentary 9-week GMT program once the final testing session is complete. Following the completion of the complimentary 9-week GMT program, individuals in the WLC will complete post-intervention testing (1-2 weeks following the completion of GMT and again at 3 months, post GMT completion).
Masking: None (Open Label)
Primary purpose: Treatment
Keywords: cognitive remediation; public safety personnel; Goal Management Training; Group therapy; first responders; military