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

Homewood Research Institute

Status: Completed

Conditions: Post-traumatic Stress Disorder; Cognitive Dysfunction

Treatments: Behavioral: Goal Management Training

Study type: Interventional

Funder types: Other

Identifiers

NCT04076839

15-29

Details and patient eligibility

About

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.

Full 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.

Enrollment: 48 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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48 participants in 2 patient groups

Goal Management Training (GMT)

Experimental group

Description:

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.

Treatment:

Behavioral: Goal Management Training

Wait-list Control

No Intervention group

Description:

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