Goal Management Training in Individuals With PTSD

NCT04457271 | Withdrawn

• 2 other identifiers: 10037116096
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

GMT; Goal Management Training; mindfulness; Cognitive Remediation

Outcome Measures

Primary Outcomes (8)

• 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.

  9 weeks

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

  12 weeks

• 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.

  9 weeks

• 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.

  12 weeks

• 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.

  9 weeks

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

  12 weeks

• 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

  9 weeks

• 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

  12 weeks

Study Arms (2)

Goal Management Training (GMT)

EXPERIMENTAL

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

Behavioral: Goal Management Training (GMT)

Wait List

NO INTERVENTION

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

Interventions

Goal Management Training (GMT) BEHAVIORAL

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).

Goal Management Training (GMT)

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

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

Sponsors & Collaborators

• London Health Sciences Centre Research Institute OR Lawson Research Institute of St. Joseph's: lead
• Canadian Institutes of Health Research (CIHR): collaborator
• FDC Foundation: collaborator

Study Sites (1)

London Health Sciences Centre - University Hospital

London, Ontario, N6A 5A5, Canada

Location

Related Publications (4)

• 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.

  PMID: 29252162 RESULT

• 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.

  PMID: 23993991 RESULT

• 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.

  PMID: 25854674 RESULT

• 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.

  PMID: 27444881 RESULT

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cognitive Dysfunction; Cognition Disorders

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Neurocognitive Disorders

Study Officials

• Ruth A. Lanius, MD, PhD

  Lawson Research Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 30, 2020
• First Posted: July 7, 2020
• Study Start: January 1, 2023
• Primary Completion: February 1, 2024
• Study Completion: February 1, 2024
• Last Updated: February 8, 2023

Record last verified: 2023-02

Data Sharing

• IPD Sharing: Will not share

Locations

CA (1)