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NCT Number: NCT06813378

(Neuro)Cognitive Remediation for Adults With OSIs

(Neuro)Cognitive remediation (CR) is an intervention for people experiencing cognitive impairments that interfere with their daily functioning. Cognition refers to a person's ability to perceive, process, manipulate and respond to information. Attention, memory, abstract reasoning, and processing speed are all examples of cognitive skills. By focusing on improving these underlying skills, the overall aim of cognitive remediation is to improve the participant's daily satisfaction and success. CR can be achieved through teaching compensatory strategies, restoration of cognition through drill and practice and by utilizing regulative metacognitive strategies. Acquired skills and strategies are then 'bridged' or applied to daily functioning with the assistance of the clinician.

This pilot study intends to assess the impacts of a CR program on a population of Military Veterans, police officers, and retirees within the Nova Scotia Operational Stress Injury Clinic (NSOSIC). Researchers believe this program will improve cognitive functioning and that participants will perceive that the program was beneficial.

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Key information

About this study

CR is used in many client populations including acquired brain injury (ABI) , attention deficit hyperactivity disorder (ADHD) and post-traumatic stress disorder (PTSD) . Research has begun a more in-depth exploration into the relationship between psychological diagnoses and cognitive impairments. Difficulties in memory, attention, problem- solving ability, and processing speed have been linked to many mental health diagnoses which results in occupational dysfunction in the areas of daily routine, self-care, productivity, leisure, and relationships. Addressing these cognitive impairments with cognitive remediation can be an important step alongside other therapies in the recovery process.

Although CR programs and strategies have been studied with the populations referenced above, it has not been sufficiently evaluated from a mental health trans-diagnostic perspective for military Veterans and police officers and retirees. Additionally, the particular a combination of compensatory, restorative and regulative cognitive remediation used in the CR program for this research has not been published about for this clinical population that has cognitive impairments, but has been used with other populations of mental health service users .

Qualitative research methods will be the focus of this pilot study as they can provide a detailed understanding of the lived experiences of individuals using a relatively small sample size. Using qualitative research methodologies is also advantageous to answer the current research question as it allows participants to share experiences from their own point of view, rather than relying on the pre-suppositions of researchers, as would likely need to be done if trying to use quantitative research methods. Qualitative data will be obtained through individual semi-structured interviews with all participants of this study. These individual interviews will result in complete transcripts of conversations which can be thoroughly analyzed by researchers. This research will use an interpretive phenomenology framework for analysis, as will be described in the data analysis phase of this document.

Quantitative research methodologies will also be used within this pilot study. Four different psychometric measures will be completed by participants at the start and end of this study:

  • Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)- a standardized assessment to screen for cognitive functioning which covers 5 domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory.
  • World Health Organization Disability Assessment Schedule 2.0 (WHODAS)- a standardized assessment measuring health and disability across cultures which covers 6 domains: cognition, mobility, self-care, getting along, life activities, and participation.
  • Patient Health Questionnaire 9 Item (PHQ-9)- A 9-item screening tool used to assess the severity of depression-related symptoms.
  • Generalized Anxiety Disorder 7 Item (GAD-7)- a 7-item screening tool used to assess the severity of anxiety-related symptoms.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Participants must be:

  • Clients engaging in treatment at the Nova Scotia OSI Clinic who may benefit from the CR program.
  • Be experiencing cognitive challenges which may be improved through the cognitive remediation program, as determined by the treating Occupational Therapist.

Exclusion criteria

Participants must not:

-Be accessing CR treatment modality through an Occupational Therapist

Treatment and study plan

(Neuro)Cognitive Remediation

Behavioral

(Neuro)Cognitive remediation is an intervention for people experiencing cognitive impairments that interfere with their daily functioning. Attention, memory, abstract reasoning, and processing speed are all examples of cognitive skills. By focusing on improving these underlying skills, the overall aim of cognitive remediation is to improve the client's daily satisfaction and success. Although cognitive remediation programs and strategies have been studied with other populations, it has not been sufficiently evaluated from a mental health trans-diagnostic perspective for military Veterans and police officers and retirees who this research will study.

Primary outcomes

  1. Participant Reported Qualitative Experience

    Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.

    Qualitative data will be obtained through individual semi-structured interviews with all participants of this study. These individual interviews will result in complete transcripts of conversations which can be thoroughly analyzed by researchers. This research will use an interpretive phenomenology framework for analysis, as will be described in the data analysis phase of this document.

Secondary outcomes

  1. 1. Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)

    Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.

    A standardized assessment to screen for cognitive functioning which covers 5 domains: Immediate Memory, Visuospatial/Constructional, Language, Attention, and Delayed Memory. Total scale scores can range from 40-160, with lower scores indicating a worse outcome.

  2. World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

    Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.

    A standardized assessment measuring health and disability across cultures which covers 6 domains: cognition, mobility, self-care, getting along, life activities, and participation. Scores on this measure can range from 0-48, with higher scores representing a worse outcome.

  3. Patient Health Questionnaire 9 Item (PHQ-9)

    Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.

    A 9-item screening tool used to assess the severity of depression-related symptoms. Scores range from 0-27 with higher scores indicating higher levels of distress.

  4. Generalized Anxiety Disorder 7 Item (GAD-7)

    Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.

    A 7-item screening tool used to assess the severity of anxiety-related symptoms. Scores range from 0-21 with higher scores indicating higher levels of distress.

  5. Montreal Cognitive Assessment

    Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.

    a questionnaire administered by a trained clinician used to detect mild cognitive impairments with lower scores indicating cognitive impairment.

Study contacts

Contact information is provided by the study sponsor or research team.

Abraham Rudnick, MD, PhD, MPsych, BMedSc

CONTACT

[email protected]

902-460-6225

Dougal M Nolan, MsC

CONTACT

[email protected]

902-219-0893

Sponsors and collaborators

Lead sponsor

Nova Scotia Health Authority

Other

Registry information

Official study title

(Neuro)Cognitive Remediation for Adults With Operational Stress Injuries

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Feb 7, 2025
Registry last updated
Jun 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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