The Effectiveness of a Cognitive Training Program, Goal Management Training, on Reducing Cognitive Difficulties and Improving Every-day Functioning in Individuals With Affective Disorders

NCT ID: NCT04076839

Last Updated: 2020-02-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 48 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-10-13
• Study Completion Date: 2019-08-16

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.

Conditions

Post-traumatic Stress Disorder; Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Goal Management Training (GMT)

Goal Management Therapy is a structured, short-term, present-oriented cognitive remediation program with emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train patients to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Participants assigned to this group will attend 9 weeks of GMT group sessions, each 2 hours in length, occurring once per week.

Group Type: EXPERIMENTAL

Goal Management Training

Intervention Type: BEHAVIORAL

Goal Management Therapy is a structured, short-term, present-oriented cognitive remediation program with emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train patients to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments.

Wait-list Control

Following baseline testing, participants randomly assigned to the wait-list control group will have no intervention during the 9 weeks that the GMT group attends their group sessions. Following the completion of the GMT group intervention, the wait-list control will attend a a testing session, and subsequently, a 3 month follow-up testing session, the results of which will be compared to those of the GMT group. This group will then be offered a complimentary 9-week GMT program once the final testing session is complete. Again, during these sessions participants will be required to complete questionnaires every third session in order to monitor their progress and symptoms. Following the completion of the complimentary 9-week GMT program, individuals in the WLC will complete post-intervention testing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

Goal Management Training

Goal Management Therapy is a structured, short-term, present-oriented cognitive remediation program with emphasis on mindfulness and practice in planning and completion of goal-oriented behaviors. The primary objective of GMT is to train patients to interrupt ongoing behavior through the resumption of executive control in order to define goal hierarchies and monitor performance in achieving goals. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McMaster University

OTHER

Sponsor Role: collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role: collaborator

Homewood Health Centre

UNKNOWN

Sponsor Role: collaborator

Homewood Research Institute

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Margaret McKinnon, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, Homewood Research Institute

Locations

Homewood Research Institute

Guelph, Ontario, Canada

Countries

Canada

References

Aupperle RL, Melrose AJ, Stein MB, Paulus MP. Executive function and PTSD: disengaging from trauma. Neuropharmacology. 2012 Feb;62(2):686-94. doi: 10.1016/j.neuropharm.2011.02.008. Epub 2011 Feb 22.

Reference Type: BACKGROUND

PMID: 21349277 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 10824502 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 22310036 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 9180650 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 24579831 (View on PubMed)

Other Identifiers

15-29

Identifier Type: -

Identifier Source: org_study_id