Recruiting

Goal Management Therapy

Sponsor:

Homewood Research Institute

Code:

NCT04251624

Conditions

Post Traumatic Stress Disorder

Cognitive Deficit

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

Interventions

Goal Management Therapy

Psychosocial Education

Study Details

Brief summary:

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.

Conditions

Post Traumatic Stress Disorder

Cognitive Deficit

Study ID

NCT04251624

Start date

Nov 1, 2019

Status verified date

Jan, 2024

Completion date

Aug, 2025

Anticipated

Primary completion date

Feb, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70

Healthy Volunteers: Accepted

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

Study Design

Enrollment

88 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: 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.

active comparator: 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.

Interventions

Goal Management Therapy

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

Psychosocial Education

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

Primary outcome measure

  • Change in Score on the Delis-Kaplan Executive Function System (D-KEFS) Tower Test [ Time Frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks ]
  • Change in Score on the Wechsler Adult Intelligence Scale-IV (WAIS-IV) Coding subtest [ Time Frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks ]
  • Change in Score on Conners Continuous Performance Task Third Edition (CPT-3) [ Time Frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks ]
  • Change in Score on the World Health Organization Disability Assessment Schedule 2.0 (WHODAS 2.0) [ Time Frame: Phase 1 (inpatient): Baseline, post-intervention at 3 weeks, and post-intervention at 3 months ]
  • Change from Baseline in Score on the Cognitive Failures Questionnaire (CFQ) at 3 weeks post-intervention and 3 months post-intervention [ Time Frame: Phase 1 (inpatient): Baseline, post-intervention at 3 weeks, and post-intervention at 3 months. This measure will also be administered during week 1, week 3, week 6, and week 9 of the intervention. ]
  • Change in Score on the Return to Work Obstacles and Self-Efficacy Scale - Common Mental Disorders (ROSES-CMD) [ Time Frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks ]
  • Change from Baseline in Score on the VOT Hooper Visual Organization Test at 3 weeks post-intervention [ Time Frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks ]
  • Change in Score on the Rey-Osterrieth Complex Figure Test (RCFT) [ Time Frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks ]
  • Change in Score on the Depression Anxiety Stress Scale (DASS-21) [ Time Frame: Phase 1 (Inpatient): Week 1, Week 3, and Week 6 of intervention, and post-intervention at 3 weeks ]
  • Change in Score on the Stroop Colour and Word Test (SCWT) [ Time Frame: Phase 1 (inpatient): Baseline and post-intervention at 3 weeks ]
  • Advanced Clinical Solutions Test of Premorbid Functioning (TOPF) [ Time Frame: Phase 1 (inpatient): Baseline only ]
  • Change from baseline in scores on the PTSD Checklist for DSM-5 (PCL-5) at post-intervention [ Time Frame: Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention ]
  • Change from baseline in scores on the Depression and Anxiety Stress Scale (DASS-21) at post-intervention [ Time Frame: Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention ]
  • Change from baseline in scores on the Sustained Attention Response Task (SART) [ Time Frame: Phase 2 (outpatient): Baseline, post-intervention at 9 weeks, 3 months post-intervention, 6 months post-intervention ]
  • Change from baseline in scores on the Cognitive Failures Questionnaire (CFQ) at post-intervention [ Time Frame: Phase 2 (outpatient): Baseline, week 3 of intervention, week 6 of intervention, post-intervention at 9 weeks, 3 months post-intervention, and 6 months post-intervention ]
  • Change from baseline in symptom severity as assessed by the Clinician-Administered PTSD Scale for DSM-5 (CAPS-5) at post-intervention [ Time Frame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks ]
  • Functional neurological change from baseline at post-intervention [ Time Frame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks ]
  • Functional neurological change from baseline at post-intervention [ Time Frame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks ]
  • Change from baseline in score on the Sustained Attention Response Task (SART) adapted for functional Magnetic Resonance Imaging (fMRI) at post-intervention [ Time Frame: Phase 3 (fMRI): Baseline and post-intervention at 9 weeks ]

Central Contacts and Locations

Central contacts

Locations

Homewood Research Institute

Recruiting

Guelph, Ontario, Canada, N1E6K9

Contacts

More Information

Sponsor

Homewood Research Institute

Last update posted

Jan 16, 2024

Last verified

Jan, 2024

Keywords

  • cognitive remediation
  • public safety personnel
  • psychosocial education
  • first responders
  • military

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Homewood Research Institute on 2024-01-16.