Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder
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|ClinicalTrials.gov Identifier: NCT02502604|
Recruitment Status : Unknown
Verified July 2015 by Margaret McKinnon, St. Joseph's Healthcare Hamilton.
Recruitment status was: Not yet recruiting
First Posted : July 20, 2015
Last Update Posted : July 20, 2015
|Condition or disease||Intervention/treatment||Phase|
|Major Depressive Disorder Post-traumatic Stress Disorder||Behavioral: Goal Management Training||Not Applicable|
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|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|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|
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.
- Verbal and Phonemic Fluency on the Controlled Oral Word Association Task [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- 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. ]
- Attention alternation on the Trail Making Test Part B [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- Forming and shifting concepts on the Wisconsin Card Sorting Task [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- 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. ]
- Inattentiveness, impulsivity, sustained attention and vigilance on Connors Continuous Performance Task [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- 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.
- 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. ]
- Contextually based memory on the Weschler Memory Scale III - Logical Memory [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- Nonverbal visuospatial memory on the Brief Visuospatial Memory Test - Revised [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- Current intellectual functioning on the Weschler Abbreviated Scale of Intelligence - II [ Time Frame: Baseline ]
- Pre-morbid intellectual functioning on the National Adult Reading Test [ Time Frame: Baseline ]
- Self-reported executive difficulities on the Dysexecutive Questionnaire [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- 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. ]
- Exposure ot childhood trauma on the Childhood Trauma Questionnaire [ Time Frame: Baseline ]
- Dissociative symptoms on the Multiscale Dissociation Inventory [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- Current depressive symptomatology on the Beck Depression Inventory - II [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- Current anxiety symptomatology on the Beck Anxiety Inventory [ Time Frame: Change from baseline to 9 week and 3 month follow-ups. ]
- Psychiatric diagnosis on the Structured Clinical Interview for DSM-IV - TR [ Time Frame: Baseline ]Assesses axis I disorders from the DSM-IV.
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 ClinicalTrials.gov identifier (NCT number): NCT02502604
|Contact: Margaret C. McKinnon, PhD, C.Psych||905-522-1155 ext firstname.lastname@example.org|
|Contact: Jenna Boyd, MSc||905-522-1155 ext email@example.com|