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

Homewood Research Institute

Status: Enrolling

Conditions: Post Traumatic Stress Disorder; Cognitive Deficit

Treatments: Behavioral: Psychosocial Education; Behavioral: Goal Management Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT04251624

19-05

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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88 participants in 2 patient groups

Goal Management Therapy

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. 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.

Treatment:

Behavioral: Goal Management Therapy

Psychosocial Education

Active Comparator group

Description:

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.

Treatment:

Behavioral: Psychosocial Education