Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT02502604
Recruitment Status : Not yet recruiting
First Posted : July 20, 2015
Last Update Posted : July 20, 2015
Information provided by (Responsible Party):
Margaret McKinnon, St. Joseph's Healthcare Hamilton

Brief 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.

Condition or disease Intervention/treatment
Major Depressive Disorder Post-traumatic Stress Disorder Behavioral: Goal Management Training

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 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.

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 128 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Investigating the Efficacy of a Top-Down Approach to Cognitive Remediation in Individuals With Affective Disorders
Study Start Date : September 2015
Estimated Primary Completion Date : August 2017
Estimated Study Completion Date : August 2018

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Goal Management Training
Participants in this arm of the study will attend GMT sessions, which will be administered weekly over a nine-week period following a script with accompanying slides and participant workbooks.
Behavioral: Goal Management Training
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.
No Intervention: Wait List Control
Participants in this category will be placed on a wait-list to receive goal management training following completion of their study participation.

Primary Outcome Measures :
  1. Verbal and Phonemic Fluency on the Controlled Oral Word Association Task [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  2. Processing speed and response inhibition on the Stoop Colour and Word Test [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  3. Attention alternation on the Trail Making Test Part B [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  4. Forming and shifting concepts on the Wisconsin Card Sorting Task [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  5. Processing speed on the Weschler Adult Intelligence Scale IV - Symbol Coding subtest [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  6. Inattentiveness, impulsivity, sustained attention and vigilance on Connors Continuous Performance Task [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  7. Working memory on the N-back Task [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
    Measures ability to maintain and manipulate auditory information in memory.

  8. Immediate and delayed memory, interference learning and recognition on the California Verbal Learning Test II [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  9. Contextually based memory on the Weschler Memory Scale III - Logical Memory [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  10. Nonverbal visuospatial memory on the Brief Visuospatial Memory Test - Revised [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  11. Current intellectual functioning on the Weschler Abbreviated Scale of Intelligence - II [ Time Frame: Baseline ]
  12. Pre-morbid intellectual functioning on the National Adult Reading Test [ Time Frame: Baseline ]
  13. Self-reported executive difficulities on the Dysexecutive Questionnaire [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  14. Self reported daily errors in distractibility, blunders, and memory on the Cognitive Failures Questionnaire [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  15. Self reported work, education, and residential functioning on the Multidimensional Scale of Independent Functioning [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  16. Disability in work, social relationships, and family life on the Sheehan Disability Scale [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  17. Functional competence on the Canadian Objective Assessment of Life Skills - Brief Version [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]

Secondary Outcome Measures :
  1. Current PTSD symptomatology on the Clinician Administered PTSD Scale for DSM 5 [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  2. Exposure ot childhood trauma on the Childhood Trauma Questionnaire [ Time Frame: Baseline ]
  3. Dissociative symptoms on the Multiscale Dissociation Inventory [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  4. Current depressive symptomatology on the Beck Depression Inventory - II [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
  5. Current anxiety symptomatology on the Beck Anxiety Inventory [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]

Other Outcome Measures:
  1. Psychiatric diagnosis on the Structured Clinical Interview for DSM-IV - TR [ Time Frame: Baseline ]
    Assesses axis I disorders from the DSM-IV.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Structured Clinical Interview for DSM-IV-TR for Axis I Disorders (SCID-I (First et al., 1996))-confirmed primary diagnosis of MDD or PTSD
  2. between the age of 18-60
  3. able to provide written informed consent.

Exclusion Criteria:

  1. Receiving treatment with anti-cholinergic or anti-psychotic medication
  2. have had ECT within the past year
  3. a history of substance dependence or significant and recent (< 1 year) substance abuse)
  4. a recent history (within the past 12 months) of medical disorder known to adversely affect cognition
  5. loss of consciousness greater than 1 minute or a history of traumatic brain injury

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02502604

Contact: Margaret C. McKinnon, PhD, C.Psych 905-522-1155 ext 36645
Contact: Jenna Boyd, MSc 905-522-1155 ext 36326

Sponsors and Collaborators
St. Joseph's Healthcare Hamilton


Responsible Party: Margaret McKinnon, Co-Chair, Research, Department of Psychiatry and Behavioural Neurosciences, St. Joseph's Healthcare Hamilton Identifier: NCT02502604     History of Changes
Other Study ID Numbers: 0416
First Posted: July 20, 2015    Key Record Dates
Last Update Posted: July 20, 2015
Last Verified: July 2015

Keywords provided by Margaret McKinnon, St. Joseph's Healthcare Hamilton:
Cognitive Remediation
Goal Management Training
Major Depressive Disorder
Post-traumatic Stress Disorder
Neuropsychological Functioning

Additional relevant MeSH terms:
Depressive Disorder
Depressive Disorder, Major
Stress Disorders, Traumatic
Stress Disorders, Post-Traumatic
Pathologic Processes
Mood Disorders
Mental Disorders
Behavioral Symptoms
Trauma and Stressor Related Disorders