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Goal Management Training in Individuals With PTSD

Primary Purpose

PTSD, Post-traumatic Stress Disorder, Cognitive Impairment

Status

Withdrawn

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Goal Management Training (GMT)

About this trial

This is an interventional treatment trial for PTSD focused on measuring GMT, Goal Management Training, mindfulness, Cognitive Remediation

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

diagnosis of PTSD as determined by our baseline assessment
Due to online nature: must have access to (and ability to use) a computer/tablet with a working microphone and camera (or webcam), reliable access to a secure internet connection, and access to a quiet, private space for the assessments and group sessions.
Ability to provide informed consent
Fluency in written and spoken English
must be resident of Ontario (due to restrictions of professional licenses)

Exclusion Criteria for those opting in to fMRI scan:

any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy)

Exclusion Criteria for study in general:

history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident as assessed retrospectively by participant)
significant untreated medical illness
history of neurological or neurodevelopmental disorder
history of any pervasive developmental disorder
any medical disorder known to adversely affect cognition within the last 12 months
lifetime bipolar or psychotic disorder
alcohol/substance abuse or dependence within the last 3 months
extensive narcotic use (e.g., fentanyl, oxycodone, etc.), use of anti-cholinergics, anti-psychotics, psychostimulants, or benzodiazepines
ECT (electroconvulsive therapy) within the last 12 months
significant dissociative disorder (as determined by our baseline assessment)
suicide attempt in last 6 months
pregnancy (due to impact of hormones on cognitive abilities)
hearing or vision issues that would interfere with effective online participation

Sites / Locations

London Health Sciences Centre - University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

No Intervention

Arm Label

Goal Management Training (GMT)

Wait List

Arm Description

Participants in this arm will attend 9 weekly, 2-hour group GMT appointments.

Participants in this arm will receive no treatment for approximately 21 weeks (at which point, they will be offered the same, standard GMT treatment).

Outcomes

Primary Outcome Measures

Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment

A computer-based go/no-go task that requires participants to withhold behavioral response to a single, infrequent target presented amidst a background of frequent non-targets. This task assesses inattentiveness, impulsivity, sustained attention, and vigilance.

Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment

Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment.

Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment.

Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment

A 36-item self-report measure that assesses difficulties with emotion regulation across six domains. A total score is derived by summing all the items - ranging from 36 to 180. Higher scores indicate greater dysfunction in emotion regulation.

Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment

Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment

Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment

Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Secondary Outcome Measures

Full Information

NCT ID

NCT04457271

First Posted

June 30, 2020

Last Updated

February 3, 2023

Sponsor

Lawson Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR), FDC Foundation

1. Study Identification

Unique Protocol Identification Number

NCT04457271

Brief Title

Goal Management Training in Individuals With PTSD

Official Title

An EffectivenessTrial Examining a Novel Approach to Cognitive Remediation in Individuals With Post-Traumatic Stress Disorder (PTSD)

Study Type

Interventional

2. Study Status

Record Verification Date

February 2023

Overall Recruitment Status

Withdrawn

Why Stopped

Unfortunately, we have had to prioritize other studies and we do not have the resources required to carry out this study.

Study Start Date

January 2023 (Anticipated)

Primary Completion Date

February 2024 (Anticipated)

Study Completion Date

February 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Lawson Health Research Institute

Collaborators

Canadian Institutes of Health Research (CIHR), FDC Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

Brief Summary

This study will evaluate the effect of a manualized treatment (Goal Management Training, or GMT) on the cognitive impairments associated with PTSD (Post-Traumatic Stress Disorder), as well as any impact on PTSD symptems themselves. Participants will be randomized to either GMT group treatment, or a wait list condition.

Detailed Description

PTSD has an emotional impact on individuals, but it is also associated with impaired cognitive functioning (e.g., processing speed, attention, executive functioning). This study is an effectiveness trial investigating a cognitive remediation intervention (Goal Management Training, or GMT) that has been shown to improve the cognitive impairment observed in other populations (e.g., older adults). The present study will investigate the impact of GMT in adults experiencing PTSD (including frontline healthcare workers suffering from PTSD related to the COVID-19 pandemic) and its associated cognitive impairment. Participants will be randomly assigned to one of two treatment conditions - GMT, or a wait list condition (in which GMT will be postponed for approximately 21 weeks). Due to the pandemic, this study will be conducted primarily online (i.e., online assessments and treatment, with optional fMRI scans - functional magnetic resonance imaging). Once all assessments are complete, participants in the wait list condition will be able to begin GMT thelmselves.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

PTSD, Post-traumatic Stress Disorder, Cognitive Impairment, Cognitive Dysfunction, Cognitive Deficit

Keywords

GMT, Goal Management Training, mindfulness, Cognitive Remediation

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

This study is an effectiveness trial investigating GMT as an intervention for both PTSD-related cognitive impairment/dysfunction, and PTSD symptoms themselves. Participants will be randomized to one of two conditions: GMT or wait list.

Masking

Outcomes Assessor

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Goal Management Training (GMT)

Arm Type

Experimental

Arm Description

Participants in this arm will attend 9 weekly, 2-hour group GMT appointments.

Arm Title

Wait List

Arm Type

No Intervention

Arm Description

Participants in this arm will receive no treatment for approximately 21 weeks (at which point, they will be offered the same, standard GMT treatment).

Intervention Type

Behavioral

Intervention Name(s)

Goal Management Training (GMT)

Intervention Description

GMT is a structured, short-term cognitive remediation program with an emphasis on mindfulness and practice in planning and completion of goal-oriented behaviours. The main objective of GMT is to help participants regain executive control in order to better define goals and monitor performance in achieving them. Sessions include instructional material, interactive tasks, discussion of patients' real-life deficits, and homework assignments. Mindfulness meditation is also incorporated for the purpose of developing the skill of bringing one's mind to the present to monitor ongoing behaviour, goal states, and the relationship between them, and for the development of attentional control. The program incorporates real-life examples to illustrate goal attainment failures and successes, as well as in-session practice of complex tasks that mimic real-life tasks - typically a challenge for individuals with executive function deficits (e.g., planning and set-shifting tasks).

Primary Outcome Measure Information:

Title

Change in Sustained Attention to Response Task (SART) scores from baseline to post-treatment assessment

Description

Time Frame

9 weeks

Title

Change in Sustained Attention to Response Task (SART) scores from post-treatment to 3-month follow-up assessment

Description

Time Frame

12 weeks

Title

Change in score on Tower Test (part of Millisecond's online cognitive battery) from baseline to post-treatment assessment.

Description

Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Time Frame

9 weeks

Title

Change in score on Tower Test (part of Millisecond's online cognitive battery) from post-treatment to 3-month follow-up assessment.

Description

Assesses the participant's ability to act with forethought, and sequence behaviour in an orderly fashion to reach specific goals (i.e., executive functioning). Similar to the Tower of London test.

Time Frame

12 weeks

Title

Change in Difficulties in Emotion Regulation Scale (DERS) score from baseline to post-treatment assessment

Description

Time Frame

9 weeks

Title

Change in Difficulties in Emotion Regulation Scale (DERS) score from post-treatment to 3-month follow-up assessment

Description

Time Frame

12 weeks

Title

Change in Clinician Administered PTSD Scale (CAPS) score from baseline to post-treatment assessment

Description

Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Time Frame

9 weeks

Title

Change in Clinician Administered PTSD Scale (CAPS) score from post-treatment to 3-month follow-up assessment

Description

Gold standard, clinician administered PTSD assessment tool; min. score=0, max=80, with higher scores representing greater PTSD symptoms

Time Frame

12 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: diagnosis of PTSD as determined by our baseline assessment Due to online nature: must have access to (and ability to use) a computer/tablet with a working microphone and camera (or webcam), reliable access to a secure internet connection, and access to a quiet, private space for the assessments and group sessions. Ability to provide informed consent Fluency in written and spoken English must be resident of Ontario (due to restrictions of professional licenses) Exclusion Criteria for those opting in to fMRI scan: any implants, conditions, etc. that do not comply with 7T (Tesla) fMRI research safety standards (e.g., pacemaker, pregnancy/possible pregnancy) Exclusion Criteria for study in general: history of significant head injury/lengthy loss of consciousness (e.g., a Glasgow Coma Scale Score < 15 at the time of incident as assessed retrospectively by participant) significant untreated medical illness history of neurological or neurodevelopmental disorder history of any pervasive developmental disorder any medical disorder known to adversely affect cognition within the last 12 months lifetime bipolar or psychotic disorder alcohol/substance abuse or dependence within the last 3 months extensive narcotic use (e.g., fentanyl, oxycodone, etc.), use of anti-cholinergics, anti-psychotics, psychostimulants, or benzodiazepines ECT (electroconvulsive therapy) within the last 12 months significant dissociative disorder (as determined by our baseline assessment) suicide attempt in last 6 months pregnancy (due to impact of hormones on cognitive abilities) hearing or vision issues that would interfere with effective online participation

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Ruth A. Lanius, MD, PhD

Organizational Affiliation

Lawson Research Institute

Official's Role

Principal Investigator

Facility Information:

Facility Name

London Health Sciences Centre - University Hospital

City

London

State/Province

Ontario

ZIP/Postal Code

N6A 5A5

Country

Canada

12. IPD Sharing Statement

Plan to Share IPD

IPD Sharing Plan Description

Only coded data will be shared with co-investigators who are registered with the study's ethics board application.

Citations:

PubMed Identifier

29252162

Citation

Boyd JE, Lanius RA, McKinnon MC. Mindfulness-based treatments for posttraumatic stress disorder: a review of the treatment literature and neurobiological evidence. J Psychiatry Neurosci. 2018 Jan;43(1):7-25. doi: 10.1503/jpn.170021. Epub 2017 Oct 2.

Results Reference

result

PubMed Identifier

23993991

Citation

Meusel LA, Hall GB, Fougere P, McKinnon MC, MacQueen GM. Neural correlates of cognitive remediation in patients with mood disorders. Psychiatry Res. 2013 Nov 30;214(2):142-52. doi: 10.1016/j.pscychresns.2013.06.007. Epub 2013 Aug 30.

Results Reference

result

PubMed Identifier

25854674

Citation

Lanius RA, Frewen PA, Tursich M, Jetly R, McKinnon MC. Restoring large-scale brain networks in PTSD and related disorders: a proposal for neuroscientifically-informed treatment interventions. Eur J Psychotraumatol. 2015 Mar 31;6:27313. doi: 10.3402/ejpt.v6.27313. eCollection 2015.

Results Reference

result

PubMed Identifier

27444881

Citation

McKinnon MC, Boyd JE, Frewen PA, Lanius UF, Jetly R, Richardson JD, Lanius RA. A review of the relation between dissociation, memory, executive functioning and social cognition in military members and civilians with neuropsychiatric conditions. Neuropsychologia. 2016 Sep;90:210-34. doi: 10.1016/j.neuropsychologia.2016.07.017. Epub 2016 Jul 18.

Results Reference

result

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Goal Management Training in Individuals With PTSD

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