Clinical trial NCT04076839: The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Improving Every-day Functioning in Individuals With Affective Disorders
Official title: The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Improving Every-day Functioning in Individuals With Affective Disorders
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Post-traumatic Stress Disorder
Cognitive Dysfunction
Keywords: cognitive remediation
public safety personnel
Goal Management Training
Group therapy
first responders
military
Lead sponsor: Homewood Research Institute
Sponsor class: OTHER
Collaborators: name: McMaster University
name: St. Joseph's Healthcare Hamilton
name: Homewood Health Centre
First posted: 2019-09-03
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Participants will be randomly assigned to either: 1) a 9-week GMT program or 2) a 9-week wait-list control (WLC) condition. Participants will be tested at baseline prior to group commencement. Once the testing session is complete, the participants will be assigned to (GMT or WLC). Participants enrolled in the GMT program will attend 9-weeks of GMT sessions (2 hours/week for 9 weeks) and a post-intervention testing session date. Participants enrolled in the WLC group will be given a testing session date after 9 weeks has past. Participants will attend a final testing session (in 3 months' time; approximately 3 hours in duration). WLC will be offered a complimentary 9-week GMT program once the final testing session is complete. Following the completion of the complimentary 9-week GMT program, individuals in the WLC will complete post-intervention testing (1-2 weeks following the completion of GMT and again at 3 months, post GMT completion).
Primary purpose: TREATMENT

Brief summary: This study investigates the utility of Goal Management Training (GMT) in patients with post-traumatic stress disorder (PTSD), in order to determine if this treatment is effective in improving cognitive function in patients with frontal-temporally mediated brain dysfunction. Specifically, the primary aim of this 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 group. A secondary aim will be to determine whether participation in the GMT group is associated with long-term functional improvements. It is hypothesized that at post-treatment, participants with PTSD assigned to the GMT groups will show greater improvement in neuropsychological test performance and greater functional improvement compared to those in the wait-list group; these gains are expected to be maintained at 3 month follow-up.

Detailed description: Given the potentially devastating impact of poor cognitive functioning on the ability of patients with PTSD 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 conduct a randomized controlled trial among patients with PTSD, examining the efficacy of a well-established cognitive intervention (in the treatment of cognitive deficits), aimed at reducing attentional and executive dysfunction, known as Goal Management Training® (GMT) (See Levine et al., 2011). A secondary aim is to determine the longer-term impact of the GMT approach on functional outcomes.

The participants include 48 men and women with a primary diagnosis of with stable symptoms at the time of baseline assessment and reporting alterations in memory, attention, or executive functioning. Participants will be recruited from multiple sites: an inpatient post-traumatic stress recovery program in Ontario, Canada, and the program's external referral agencies that also service clients via outpatient services/ programs, external community agencies and support groups, and through social media.

Following determination of eligibility, participants will be randomly assigned, by using the randomized table of numbers method, to either: 1) a 9-week GMT program or 2) a 9-week wait-list control (WLC) condition (see Figure 1). Participants will be invited to attend a baseline testing session 1 prior to group commencement (approximately 4 hours in duration) where written consent will be obtained prior to any collection of data. Once the testing session is complete, the participants will be given information about what group they have been assigned to (GMT or WLC).

Participants enrolled in the GMT program attended the 9-week GMT sessions (2 hours/week for 9 weeks) and a post-intervention testing session date (1-2 weeks following the completion of the GMT; approximately 3 hours in duration). Participants enrolled in the WLC control group attended a testing session date after 9 weeks has past (approximately 3 hours in duration).

As each participant completed a post-intervention testing session (both GMT and WLC), they will be setup with the final testing session (in 3 months' time; approximately 3 hours in duration). WLC were offered a complimentary 9-week GMT program once the final testing session is complete. Following the completion of the complimentary 9-week GMT program, individuals in the WLC completed a post-intervention testing (1-2 weeks following the completion of GMT and again at 3 months, post GMT completion).

These data will be analyzed using 2 x 3 mixed-design split plot factorial ANCOVAs that treat Group (GMT vs. WLC) as a between-subjects factor and Time (baseline, post-intervention, 3 months; subjects nested within groups) as a within-subjects factor. In addition, within-subjects analyses of covariance (ANCOVAS) treating time (baseline, post-intervention, 3 months) as a within-subjects factor will be carried out on data collected from the GMT group and from the WLC group after they have completed the GMT arm of the study. PTSD symptom severity (CAPS), depressive symptom severity (BDI-II), severity of past trauma exposure (CTQ), and medication load, and additional psychological treatment (treatment information form) will serve as covariates in this model. Tukey's Honestly Significant Difference post-hoc test will be used for follow-up pair-wise comparisons of between-subjects' variables.

It is hypothesized that, post-treatment, participants with PTSD assigned to the GMT group will show significantly greater improvement in neuropsychological test performance and greater functional improvement compared to participants in the wait-list control group; these gains are expected to be maintained at 3-month-follow-up.

Eligibility criteria: Inclusion Criteria:

* Between the ages of 18-70
* Are fluent in written and spoken English
* Are able to provide written informed consent
* Have a confirmed primary diagnosis of PTSD, history of PTSD diagnosis, or a history of trauma exposure as confirmed by the Mini International Neuropsychiatric Interview.

Exclusion Criteria:

* Are not current or former military personnel/ veterans or first responders/ public safety personnel
* Indicate alcohol and/or substance abuse within the past 3 months
* Have a recent history (within the past 12 months) of medical disorder known to adversely affect cognition.

Primary outcomes:
measure: Change in score on Controlled Oral Word Association Task (COWAT)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in score on Stroop Colour and Word Test
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in score on Delis-Kaplan Executive Function System (D-KEFS) Tower Test
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in score on Trail Making Test Part A & B (TMT A & TMT B)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in score on Wechsler Adult Intelligence Scale-IV (WAIS-IV), Coding Subtest
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in score on Conners Continuous Performance Task Third Edition (CPT-III)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in score on California Verbal Learning Test II (CVLT-II)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in score on Rivermead Behavioural Memory Test Second Edition (RBMT-II) Prospective Memory Tasks
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Wechsler Abbreviated Scale of Intelligence - II (WASI-II): Vocabulary and Matrix Reasoning Subtests
timeFrame: Administered to GMT participants and Waitlist Participants only at baseline.
measure: Wechsler Test of Adult Reading (WTAR)
timeFrame: Administered to GMT participants and Waitlist Participants only at baseline.
measure: Change in Score on Multidimensional Scale of Independent Functioning (MSIF)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Sheehan Disability Scale (SDS)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Goal Attainment Scaling (GAS)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Cognitive Failures Questionnaire (CFQ)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months). Also GMT sessions 1,3,6, and 9
measure: Change in Score on Dysexecutive Questionnaire (DEX)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
Secondary outcomes:
measure: Demographic Information
timeFrame: Administered to GMT participants and Waitlist Participants only at baseline.
measure: Mini International Neuropsychiatric Interview 7.0 (M.I.N.I.)
timeFrame: Administered to GMT participants and Waitlist Participants only at baseline.
measure: Clinician-Administered PTSD Scale for DSM-5 (CAPS-5)
timeFrame: Administered to GMT participants and Waitlist Participants only at baseline.
measure: Life Events Checklist for DSM-5 (LEC)
timeFrame: Administered to GMT participants and Waitlist Participants only at baseline.
measure: Childhood Trauma Questionnaire (CTQ)
timeFrame: Administered to GMT participants and Waitlist Participants only at baseline.
measure: Change in Score on Psychological Treatment and Medication Assessment
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on PTSD Checklist for DSM-5 (PCL-5)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months). Also GMT sessions 1,3,6, and 9
measure: Change in Score on Multiscale Dissociation Inventory (MDI)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months). Also GMT sessions 1,3,6, and 9
measure: Change in Score on Difficulties in Emotion Regulation Scale (DERS)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months). Also GMT sessions 1,3,6, and 9
measure: Change in Score on Beck Depression Inventory II (BDI-II)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months). Also GMT sessions 1,3,6, and 9
measure: Change in Score on Beck Anxiety Inventory (BAI)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months). Also GMT sessions 1,3,6, and 9
measure: Change in Score on Emotion Regulation Questionnaire (ERQ)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Toronto Alexithymia Scale (TAS)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Dissociation Tension Scale (DSS)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on The Short Version of the Borderline Symptom List (BSL-23)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Moral Injury Events Scale (MIES)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Trauma-Related Guilt Inventory (TRGI)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: Change in Score on Trauma-Related Shame Inventory (TRSI)
timeFrame: GMT group: Baseline, post-treatment (9 weeks), and 3 months. Wait list control: Baseline, post 9 week delay period, post 3 month delay period, post GMT (8 months), 3 months post-treatment (11 months)
measure: GMT Treatment Evaluation Form
timeFrame: Anonymous feedback collected following the participation in the GMT treatment portion of the study (9 weeks for GMT group, 8 months for wait list control)
Other outcomes:
Locations:
city: Guelph
country: Canada
facility: Homewood Research Institute
state: Ontario
Study officials:
affiliation: McMaster University, Homewood Research Institute
name: Margaret McKinnon, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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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.
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.
citation: Rockwood K, Joyce B, Stolee P. Use of goal attainment scaling in measuring clinically important change in cognitive rehabilitation patients. J Clin Epidemiol. 1997 May;50(5):581-8. doi: 10.1016/s0895-4356(97)00014-0.
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