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

NCT02502604 | Completed

• 1 other identifier: 0416
• Study Type: interventional
• Target: 58
• Locations: 1 country
• Sites: 1

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.

Conditions

Major Depressive Disorder; Post-traumatic Stress Disorder

Keywords

Cognitive Remediation; Goal Management Training; Major Depressive Disorder; Post-traumatic Stress Disorder; Neuropsychological Functioning

Outcome Measures

Primary Outcomes (17)

• Verbal and Phonemic Fluency on the Controlled Oral Word Association Task

  Change from baseline to 9 week and 3 month follow-ups.

• Processing speed and response inhibition on the Stoop Colour and Word Test

  Change from baseline to 9 week and 3 month follow-ups.

• Attention alternation on the Trail Making Test Part B

  Change from baseline to 9 week and 3 month follow-ups.

• Forming and shifting concepts on the Wisconsin Card Sorting Task

  Change from baseline to 9 week and 3 month follow-ups.

• Processing speed on the Weschler Adult Intelligence Scale IV - Symbol Coding subtest

  Change from baseline to 9 week and 3 month follow-ups.

• Inattentiveness, impulsivity, sustained attention and vigilance on Connors Continuous Performance Task

  Change from baseline to 9 week and 3 month follow-ups.

• Working memory on the N-back Task

  Measures ability to maintain and manipulate auditory information in memory.

  Change from baseline to 9 week and 3 month follow-ups.

• Immediate and delayed memory, interference learning and recognition on the California Verbal Learning Test II

  Change from baseline to 9 week and 3 month follow-ups.

• Contextually based memory on the Weschler Memory Scale III - Logical Memory

  Change from baseline to 9 week and 3 month follow-ups.

• Nonverbal visuospatial memory on the Brief Visuospatial Memory Test - Revised

  Change from baseline to 9 week and 3 month follow-ups.

• Current intellectual functioning on the Weschler Abbreviated Scale of Intelligence - II

  Baseline

• Pre-morbid intellectual functioning on the National Adult Reading Test

  Baseline

• Self-reported executive difficulties on the Dysexecutive Questionnaire

  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

  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

  Change from baseline to 9 week and 3 month follow-ups.

• Disability in work, social relationships, and family life on the Sheehan Disability Scale

  Change from baseline to 9 week and 3 month follow-ups.

• Functional competence on the Canadian Objective Assessment of Life Skills - Brief Version

  Change from baseline to 9 week and 3 month follow-ups.

Secondary Outcomes (5)

• Current PTSD symptomatology on the Clinician Administered PTSD Scale for DSM 5

  Change from baseline to 9 week and 3 month follow-ups.

• Exposure ot childhood trauma on the Childhood Trauma Questionnaire

  Baseline

• Dissociative symptoms on the Multiscale Dissociation Inventory

  Change from baseline to 9 week and 3 month follow-ups.

• Current depressive symptomatology on the Beck Depression Inventory - II

  Change from baseline to 9 week and 3 month follow-ups.

• Current anxiety symptomatology on the Beck Anxiety Inventory

  Change from baseline to 9 week and 3 month follow-ups.

Other Outcomes (1)

• Psychiatric diagnosis on the Structured Clinical Interview for DSM-IV - Text Revision

  Baseline

Study Arms (2)

Goal Management Training

EXPERIMENTAL

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

Wait List Control

NO INTERVENTION

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

Interventions

Goal Management Training BEHAVIORAL

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.

Goal Management Training

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• St. Joseph's Healthcare Hamilton: lead

Study Sites (1)

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N3K7, Canada

Location

Related Publications (15)

• 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.

  PMID: 17391343 BACKGROUND

• 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.

  PMID: 19835870 BACKGROUND

• 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.

  PMID: 22310036 BACKGROUND

• 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.

  PMID: 10940443 BACKGROUND

• 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.

  PMID: 17868903 BACKGROUND

• 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.

  PMID: 17166313 BACKGROUND

• 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.

  PMID: 21369362 BACKGROUND

• 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.

  PMID: 10824502 BACKGROUND

• 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.

  PMID: 24579831 BACKGROUND

• 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.

  PMID: 17610766 BACKGROUND

• 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.

  PMID: 24495918 BACKGROUND

• 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.

  PMID: 23264370 BACKGROUND

• 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.

  PMID: 23575309 BACKGROUND

• 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.

  PMID: 21277705 BACKGROUND

• 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.

  PMID: 33042571 DERIVED

MeSH Terms

Conditions

Depressive Disorder, Major; Stress Disorders, Post-Traumatic

Condition Hierarchy (Ancestors)

Depressive Disorder; Mood Disorders; Mental Disorders; Stress Disorders, Traumatic; Trauma and Stressor Related Disorders

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Co-Chair, Research, Department of Psychiatry and Behavioural Neurosciences

Study Record Dates

• First Submitted: July 15, 2015
• First Posted: July 20, 2015
• Study Start: September 1, 2015
• Primary Completion: August 1, 2018
• Study Completion: August 1, 2018
• Last Updated: February 11, 2021

Record last verified: 2021-02

Locations

CA (1)