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

Primary Purpose

Major Depressive Disorder, Post-traumatic Stress Disorder

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Goal Management Training
Sponsored by
St. Joseph's Healthcare Hamilton
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Major Depressive Disorder focused on measuring Cognitive Remediation, Goal Management Training, Major Depressive Disorder, Post-traumatic Stress Disorder, Neuropsychological Functioning

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesDoes not accept healthy volunteers

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 electroconvulsive therapy 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

Sites / Locations

  • St. Joseph's Healthcare Hamilton

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Goal Management Training

Wait List Control

Arm Description

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.

Participants in this category will be placed on a wait-list to receive goal management training following completion of their study participation.

Outcomes

Primary Outcome Measures

Verbal and Phonemic Fluency on the Controlled Oral Word Association Task
Processing speed and response inhibition on the Stoop Colour and Word Test
Attention alternation on the Trail Making Test Part B
Forming and shifting concepts on the Wisconsin Card Sorting Task
Processing speed on the Weschler Adult Intelligence Scale IV - Symbol Coding subtest
Inattentiveness, impulsivity, sustained attention and vigilance on Connors Continuous Performance Task
Working memory on the N-back Task
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
Contextually based memory on the Weschler Memory Scale III - Logical Memory
Nonverbal visuospatial memory on the Brief Visuospatial Memory Test - Revised
Current intellectual functioning on the Weschler Abbreviated Scale of Intelligence - II
Pre-morbid intellectual functioning on the National Adult Reading Test
Self-reported executive difficulties on the Dysexecutive Questionnaire
Self reported daily errors in distractibility, blunders, and memory on the Cognitive Failures Questionnaire
Self reported work, education, and residential functioning on the Multidimensional Scale of Independent Functioning
Disability in work, social relationships, and family life on the Sheehan Disability Scale
Functional competence on the Canadian Objective Assessment of Life Skills - Brief Version

Secondary Outcome Measures

Current PTSD symptomatology on the Clinician Administered PTSD Scale for DSM 5
Exposure ot childhood trauma on the Childhood Trauma Questionnaire
Dissociative symptoms on the Multiscale Dissociation Inventory
Current depressive symptomatology on the Beck Depression Inventory - II
Current anxiety symptomatology on the Beck Anxiety Inventory

Full Information

First Posted
July 15, 2015
Last Updated
February 8, 2021
Sponsor
St. Joseph's Healthcare Hamilton
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1. Study Identification

Unique Protocol Identification Number
NCT02502604
Brief Title
Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder
Official Title
Investigating the Efficacy of a Top-Down Approach to Cognitive Remediation in Individuals With Affective Disorders
Study Type
Interventional

2. Study Status

Record Verification Date
February 2021
Overall Recruitment Status
Completed
Study Start Date
September 2015 (Actual)
Primary Completion Date
August 2018 (Actual)
Study Completion Date
August 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
St. Joseph's Healthcare Hamilton

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Major Depressive Disorder, Post-traumatic Stress Disorder
Keywords
Cognitive Remediation, Goal Management Training, Major Depressive Disorder, Post-traumatic Stress Disorder, Neuropsychological Functioning

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
58 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Goal Management Training
Arm Type
Experimental
Arm Description
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.
Arm Title
Wait List Control
Arm Type
No Intervention
Arm Description
Participants in this category will be placed on a wait-list to receive goal management training following completion of their study participation.
Intervention Type
Behavioral
Intervention Name(s)
Goal Management Training
Intervention Description
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.
Primary Outcome Measure Information:
Title
Verbal and Phonemic Fluency on the Controlled Oral Word Association Task
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
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.
Title
Attention alternation on the Trail Making Test Part B
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
Forming and shifting concepts on the Wisconsin Card Sorting Task
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
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.
Title
Inattentiveness, impulsivity, sustained attention and vigilance on Connors Continuous Performance Task
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
Working memory on the N-back Task
Description
Measures ability to maintain and manipulate auditory information in memory.
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
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.
Title
Contextually based memory on the Weschler Memory Scale III - Logical Memory
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
Nonverbal visuospatial memory on the Brief Visuospatial Memory Test - Revised
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
Current intellectual functioning on the Weschler Abbreviated Scale of Intelligence - II
Time Frame
Baseline
Title
Pre-morbid intellectual functioning on the National Adult Reading Test
Time Frame
Baseline
Title
Self-reported executive difficulties on the Dysexecutive Questionnaire
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
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.
Title
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.
Title
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.
Title
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 Measure Information:
Title
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.
Title
Exposure ot childhood trauma on the Childhood Trauma Questionnaire
Time Frame
Baseline
Title
Dissociative symptoms on the Multiscale Dissociation Inventory
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
Current depressive symptomatology on the Beck Depression Inventory - II
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Title
Current anxiety symptomatology on the Beck Anxiety Inventory
Time Frame
Change from baseline to 9 week and 3 month follow-ups.
Other Pre-specified Outcome Measures:
Title
Psychiatric diagnosis on the Structured Clinical Interview for DSM-IV - Text Revision
Description
Assesses axis I disorders from the DSM-IV.
Time Frame
Baseline

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Structured Clinical Interview for DSM-IV-TR for Axis I Disorders (SCID-I (First et al., 1996))-confirmed primary diagnosis of MDD or PTSD between the age of 18-60 able to provide written informed consent. Exclusion Criteria: Receiving treatment with anti-cholinergic or anti-psychotic medication have had electroconvulsive therapy within the past year a history of substance dependence or significant and recent (< 1 year) substance abuse) a recent history (within the past 12 months) of medical disorder known to adversely affect cognition loss of consciousness greater than 1 minute or a history of traumatic brain injury
Facility Information:
Facility Name
St. Joseph's Healthcare Hamilton
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N3K7
Country
Canada

12. IPD Sharing Statement

Citations:
PubMed Identifier
17391343
Citation
Jaeger J, Vieta E. Functional outcome and disability in bipolar disorders: ongoing research and future directions. Bipolar Disord. 2007 Feb-Mar;9(1-2):1-2. doi: 10.1111/j.1399-5618.2007.00441.x. No abstract available.
Results Reference
background
PubMed Identifier
19835870
Citation
Marazziti D, Consoli G, Picchetti M, Carlini M, Faravelli L. Cognitive impairment in major depression. Eur J Pharmacol. 2010 Jan 10;626(1):83-6. doi: 10.1016/j.ejphar.2009.08.046. Epub 2009 Oct 14.
Results Reference
background
PubMed Identifier
22310036
Citation
Polak AR, Witteveen AB, Reitsma JB, Olff M. The role of executive function in posttraumatic stress disorder: a systematic review. J Affect Disord. 2012 Dec 1;141(1):11-21. doi: 10.1016/j.jad.2012.01.001. Epub 2012 Feb 5.
Results Reference
background
PubMed Identifier
10940443
Citation
Dunkin JJ, Leuchter AF, Cook IA, Kasl-Godley JE, Abrams M, Rosenberg-Thompson S. Executive dysfunction predicts nonresponse to fluoxetine in major depression. J Affect Disord. 2000 Oct;60(1):13-23. doi: 10.1016/s0165-0327(99)00157-3.
Results Reference
background
PubMed Identifier
17868903
Citation
Altshuler LL, Bearden CE, Green MF, van Gorp W, Mintz J. A relationship between neurocognitive impairment and functional impairment in bipolar disorder: a pilot study. Psychiatry Res. 2008 Jan 15;157(1-3):289-93. doi: 10.1016/j.psychres.2007.01.001. Epub 2007 Sep 14.
Results Reference
background
PubMed Identifier
17166313
Citation
Levine B, Stuss DT, Winocur G, Binns MA, Fahy L, Mandic M, Bridges K, Robertson IH. Cognitive rehabilitation in the elderly: effects on strategic behavior in relation to goal management. J Int Neuropsychol Soc. 2007 Jan;13(1):143-52. doi: 10.1017/S1355617707070178.
Results Reference
background
PubMed Identifier
21369362
Citation
Levine B, Schweizer TA, O'Connor C, Turner G, Gillingham S, Stuss DT, Manly T, Robertson IH. Rehabilitation of executive functioning in patients with frontal lobe brain damage with goal management training. Front Hum Neurosci. 2011 Feb 17;5:9. doi: 10.3389/fnhum.2011.00009. eCollection 2011.
Results Reference
background
PubMed Identifier
10824502
Citation
Levine B, Robertson IH, Clare L, Carter G, Hong J, Wilson BA, Duncan J, Stuss DT. Rehabilitation of executive functioning: an experimental-clinical validation of goal management training. J Int Neuropsychol Soc. 2000 Mar;6(3):299-312. doi: 10.1017/s1355617700633052.
Results Reference
background
PubMed Identifier
24579831
Citation
Saunders N, Downham R, Turman B, Kropotov J, Clark R, Yumash R, Szatmary A. Working memory training with tDCS improves behavioral and neurophysiological symptoms in pilot group with post-traumatic stress disorder (PTSD) and with poor working memory. Neurocase. 2015;21(3):271-8. doi: 10.1080/13554794.2014.890727. Epub 2014 Feb 28.
Results Reference
background
PubMed Identifier
17610766
Citation
Elgamal S, McKinnon MC, Ramakrishnan K, Joffe RT, MacQueen G. Successful computer-assisted cognitive remediation therapy in patients with unipolar depression: a proof of principle study. Psychol Med. 2007 Sep;37(9):1229-38. doi: 10.1017/S0033291707001110. Epub 2007 Jul 5.
Results Reference
background
PubMed Identifier
24495918
Citation
Krasny-Pacini A, Limond J, Evans J, Hiebel J, Bendjelida K, Chevignard M. Context-sensitive goal management training for everyday executive dysfunction in children after severe traumatic brain injury. J Head Trauma Rehabil. 2014 Sep-Oct;29(5):E49-64. doi: 10.1097/HTR.0000000000000015.
Results Reference
background
PubMed Identifier
23264370
Citation
In de Braek DMJM, Dijkstra JB, Ponds RW, Jolles J. Goal Management Training in Adults With ADHD: An Intervention Study. J Atten Disord. 2017 Nov;21(13):1130-1137. doi: 10.1177/1087054712468052. Epub 2012 Dec 20.
Results Reference
background
PubMed Identifier
23575309
Citation
Stubberud J, Langenbahn D, Levine B, Stanghelle J, Schanke AK. Goal management training of executive functions in patients with spina bifida: a randomized controlled trial. J Int Neuropsychol Soc. 2013 Jul;19(6):672-85. doi: 10.1017/S1355617713000209. Epub 2013 Apr 11.
Results Reference
background
PubMed Identifier
21277705
Citation
Alfonso JP, Caracuel A, Delgado-Pastor LC, Verdejo-Garcia A. Combined Goal Management Training and Mindfulness meditation improve executive functions and decision-making performance in abstinent polysubstance abusers. Drug Alcohol Depend. 2011 Aug 1;117(1):78-81. doi: 10.1016/j.drugalcdep.2010.12.025. Epub 2011 Feb 1.
Results Reference
background
PubMed Identifier
33042571
Citation
Cameron DH, McCabe RE, Rowa K, O'Connor C, McKinnon MC. A pilot study examining the use of Goal Management Training in individuals with obsessive-compulsive disorder. Pilot Feasibility Stud. 2020 Oct 6;6:151. doi: 10.1186/s40814-020-00684-0. eCollection 2020.
Results Reference
derived

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

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