Investigating the Use of Goal Management Therapy in Improving Cognitive Functioning in Public Safety Personnel With PTSD

NCT ID: NCT04251624

Last Updated: 2024-01-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-11-01

Study Completion Date

2025-08-31

Brief Summary

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This study examines the efficacy of Goal Management Therapy (GMT) - a well-established cognitive remediation strategy aimed at improving goal-directed behaviors that are dependent on basic cognitive processes and on executive functioning - among public safety personnel with post-traumatic stress disorder.

Detailed Description

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Goal Management Therapy is a structured, short-term, CBT-based, cognitive remediation program with an emphasis on mindfulness, and practice in planning and completion of goal-oriented behaviours. The primary objective of GMT is to train participants to interrupt ongoing, disruptive behaviour 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 real-life deficits, and homework/practice activities.

The matched psychosocial education control group will focus on educating participants on topics like brain function and neuroplasticity, and on practicing lifestyle interventions (e.g., sleep hygiene, stress management, exercise).

The study will take place in three phases:

Phase 1 will consist of 6 sessions of Goal Management Therapy and 6 sessions of psychosocial education among public safety personnel and civilians who are inpatients at a mental health and addiction facility.

Phase 2 will consist of 9 sessions of Goal Management Therapy and 9 sessions of psychosocial education among public safety personnel who are members of the local community.

Phase 3 will consist of 9 sessions of Goal Management Therapy and 9 sessions of psychosocial education among public safety personnel who are members of the local community. This phase will also use functional Magnetic Resonance Imaging (fMRI) scans to investigate potential changes in the neurobiology of participants' brains.

Conditions

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Post Traumatic Stress Disorder Cognitive Deficit

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Participants assigned to the experimental group (Goal Management Therapy) will receive either 6 (phase 1) or 9 (phase 2 and phase 3) group therapy sessions.

The matched control group (psychosocial education) will receive an equal number of group therapy sessions.

Each session will be 2 hours long.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Goal Management Therapy

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.

Phase 1: Inpatients will attend group sessions twice per week for 3 weeks, each session being 2 hours in length.

Phase 2: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.

Phase 3: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.

Group Type EXPERIMENTAL

Goal Management Therapy

Intervention Type BEHAVIORAL

A cognitive training program aimed at improving cognitive deficits such as in memory, attention, learning, and executive functioning.

Psychosocial Education

Psychosocial education will provide participants with educational materials (e.g., brain function, neuroplasticity) and lifestyle interventions (e.g., sleep hygiene, stress, exercise).

They will be matched for length and for amount of facilitator contact with the Goal Management Therapy sessions.

Phase 1: Inpatients will attend group sessions twice per week for 3 weeks, each session being 2 hours in length.

Phase 2: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.

Phase 3: Outpatients from the community will attend 1 session per week for 9 weeks, each session being 2 hours in length.

Group Type ACTIVE_COMPARATOR

Psychosocial Education

Intervention Type BEHAVIORAL

A group therapy program focusing on brain function, neuroplasticity, and lifestyle interventions.

Interventions

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Goal Management Therapy

A cognitive training program aimed at improving cognitive deficits such as in memory, attention, learning, and executive functioning.

Intervention Type BEHAVIORAL

Psychosocial Education

A group therapy program focusing on brain function, neuroplasticity, and lifestyle interventions.

Intervention Type BEHAVIORAL

Other Intervention Names

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Goal Management Training

Eligibility Criteria

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Inclusion Criteria

* have a diagnosis of post-traumatic stress disorder on the Clinician Administered PTSD Scale (CAPS)
* are able to provide written informed consent

Exclusion Criteria

* receiving treatment with anti-cholinergics, anti-psychotic medication, or psychostimulants
* use of benzodiazepines within the last 24 hours
* have had Electroconvulsive therapy within the past year
* a diagnosis of substance dependence or abuse within the past 6 months
* a recent history (within the past 12 months) of medical disorder known to adversely affect cognition
* a history of head trauma with more than one minute of loss of consciousness or a history of traumatic brain injury
* a history of neurological disorder
* a diagnosis of psychotic disorder or bipolar disorder
* a history of a neurodevelopmental disorder
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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McMaster University

OTHER

Sponsor Role collaborator

St. Joseph's Healthcare Hamilton

OTHER

Sponsor Role collaborator

Canadian Institutes of Health Research (CIHR)

OTHER_GOV

Sponsor Role collaborator

Homewood Health Centre

UNKNOWN

Sponsor Role collaborator

Homewood Research Institute

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Margaret McKinnon, PhD

Role: PRINCIPAL_INVESTIGATOR

McMaster University, St. Joseph's Healthcare Hamilton, Homewood Research Institute

Locations

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Homewood Research Institute

Guelph, Ontario, Canada

Site Status RECRUITING

Countries

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Canada

Central Contacts

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Heather Millman, MA

Role: CONTACT

519-824-1010 ext. 32180

Facility Contacts

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Heather Millman, MA

Role: primary

519-824-1010 ext. 32180

References

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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.

Reference Type BACKGROUND
PMID: 29252162 (View on PubMed)

Boyd JE, Protopopescu A, O'Connor C, Neufeld RWJ, Jetly R, Hood HK, Lanius RA, McKinnon MC. Dissociative symptoms mediate the relation between PTSD symptoms and functional impairment in a sample of military members, veterans, and first responders with PTSD. Eur J Psychotraumatol. 2018 May 17;9(1):1463794. doi: 10.1080/20008198.2018.1463794. eCollection 2018.

Reference Type BACKGROUND
PMID: 29805778 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 27444881 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23993991 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 25854674 (View on PubMed)

Provided Documents

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Document Type: Informed Consent Form

View Document

Other Identifiers

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19-05

Identifier Type: -

Identifier Source: org_study_id

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