Major Depressive DisorderNCT02502604
Cognitive Training Program for Individuals With Depression and Post-Traumatic Stress Disorder
A study testing Goal Management Training in people with Major Depressive Disorder and Post-traumatic Stress Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Major Depressive Disorder, Post-traumatic Stress Disorder
- What is being tested?
- Goal Management Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 58 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2015to Aug 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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.
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Investigating the Efficacy of a Top-Down Approach to Cognitive Remediation in Individuals With Affective Disorders
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.
Read the 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.
- Being tested
- Goal Management Training
- Keywords
- Cognitive Remediation, Goal Management Training, Major Depressive Disorder, Post-traumatic Stress Disorder, Neuropsychological Functioning
- Medical subject headings
- Depressive Disorder, Major, Stress Disorders, Post-Traumatic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Goal Management TrainingBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Verbal and Phonemic Fluency on the Controlled Oral Word Association Task
Measured: Change from baseline to 9 week and 3 month follow-ups.
Processing speed and response inhibition on the Stoop Colour and Word Test
Measured: Change from baseline to 9 week and 3 month follow-ups.
Attention alternation on the Trail Making Test Part B
Measured: Change from baseline to 9 week and 3 month follow-ups.
Forming and shifting concepts on the Wisconsin Card Sorting Task
Measured: Change from baseline to 9 week and 3 month follow-ups.
Processing speed on the Weschler Adult Intelligence Scale IV - Symbol Coding subtest
Measured: Change from baseline to 9 week and 3 month follow-ups.
Inattentiveness, impulsivity, sustained attention and vigilance on Connors Continuous Performance Task
Measured: 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.
Measured: 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
Measured: Change from baseline to 9 week and 3 month follow-ups.
Contextually based memory on the Weschler Memory Scale III - Logical Memory
Measured: Change from baseline to 9 week and 3 month follow-ups.
Nonverbal visuospatial memory on the Brief Visuospatial Memory Test - Revised
Measured: Change from baseline to 9 week and 3 month follow-ups.
Current intellectual functioning on the Weschler Abbreviated Scale of Intelligence - II
Measured: Baseline
Pre-morbid intellectual functioning on the National Adult Reading Test
Measured: Baseline
Self-reported executive difficulties on the Dysexecutive Questionnaire
Measured: 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
Measured: 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
Measured: Change from baseline to 9 week and 3 month follow-ups.
Disability in work, social relationships, and family life on the Sheehan Disability Scale
Measured: Change from baseline to 9 week and 3 month follow-ups.
Functional competence on the Canadian Objective Assessment of Life Skills - Brief Version
Measured: 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
Measured: Change from baseline to 9 week and 3 month follow-ups.
Exposure ot childhood trauma on the Childhood Trauma Questionnaire
Measured: Baseline
Dissociative symptoms on the Multiscale Dissociation Inventory
Measured: Change from baseline to 9 week and 3 month follow-ups.
Current depressive symptomatology on the Beck Depression Inventory - II
Measured: Change from baseline to 9 week and 3 month follow-ups.
Current anxiety symptomatology on the Beck Anxiety Inventory
Measured: Change from baseline to 9 week and 3 month follow-ups.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2015 (estimated)
- Study startSep 2015
- Primary completionAug 2018
- Study completionAug 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (15)Papers the sponsor has linked to this study.
- Other trials for Major Depressive DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 58 participants (actual)
Sponsor and investigators
- Lead sponsor
- St. Joseph's Healthcare Hamilton
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Margaret McKinnon, St. Joseph's Healthcare Hamilton
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02502604
- Sponsor's protocol ID
- 0416
- Status last verified
- Feb 2021
- First submitted
- 15 Jul 2015
- Last updated
- 11 Feb 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 17391343Marazziti 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.
PubMed 19835870Polak 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.
PubMed 22310036Dunkin 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.
PubMed 10940443Altshuler 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.
PubMed 17868903Levine 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.
PubMed 17166313Levine 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.
PubMed 21369362Levine 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.
PubMed 10824502Saunders 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.
PubMed 24579831Elgamal 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.
PubMed 17610766Krasny-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.
PubMed 24495918In 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.
PubMed 23264370Stubberud 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.
PubMed 23575309Alfonso 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.
PubMed 21277705Cameron 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.
PubMed 33042571
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Efficacy of a Top-Down Approach to Cognitive Remediation in Individuals With Affective Disorders
- ClinicalTrials.gov ID
- NCT02502604
- Acronym / sponsor ID
- 0416
- Keywords
- Cognitive Remediation, Goal Management Training, Major Depressive Disorder, Post-traumatic Stress Disorder, Neuropsychological Functioning
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 58 participants (actual)
- Lead sponsor
- St. Joseph's Healthcare HamiltonUniversity, hospital or other
- Study start
- Sep 2015 (actual)
- Primary completion
- Aug 2018 (actual)
- Study completion
- Aug 2018 (actual)
- First posted
- 20 Jul 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Goal Management Training | Experimental | Behavioral: Goal Management TrainingParticipants 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. |
| 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. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Goal Management TrainingGoal 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. | Behavioural | Goal Management Training |
Primary outcome
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 difficulties 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.
5 secondary outcomes
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Background: PubMed 17391343Jaeger 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.
- Background: PubMed 19835870Marazziti 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.
- Background: PubMed 22310036Polak 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.
- Background: PubMed 10940443Dunkin 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.
- Background: PubMed 17868903Altshuler 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.
- Background: PubMed 17166313Levine 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.
- Background: PubMed 21369362Levine 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.
- Background: PubMed 10824502Levine 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.
- Background: PubMed 24579831Saunders 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.
- Background: PubMed 17610766Elgamal 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.
- Background: PubMed 24495918Krasny-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.
- Background: PubMed 23264370In 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Goal Management Training in people with Major Depressive Disorder and Post-traumatic Stress Disorder, run by St. Joseph's Healthcare Hamilton at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Verbal and Phonemic Fluency on the Controlled Oral Word Association Task (time frame: Change from baseline to 9 week and 3 month follow-ups.). The study lists 17 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02502604, which also lists 15 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Feb 2021.