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(Neuro)Cognitive Remediation for Adults With OSIs

(Neuro)Cognitive Remediation for Adults With Operational Stress Injuries

Status
Not yet recruiting
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06813378
Enrollment
20
Registered
2025-02-07
Start date
2025-08-31
Completion date
2026-12-31
Last updated
2025-06-08

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cognitive Dysfunction, Cognitive Impairment, PTSD

Keywords

PTSD, Military, Veteran, Cognitive Remediation

Brief summary

(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.

Detailed description

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: 1. 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. 2. 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. 3. Patient Health Questionnaire 9 Item (PHQ-9)- A 9-item screening tool used to assess the severity of depression-related symptoms. 4. Generalized Anxiety Disorder 7 Item (GAD-7)- a 7-item screening tool used to assess the severity of anxiety-related symptoms.

Interventions

BEHAVIORAL(Neuro)Cognitive Remediation

(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.

Sponsors

Nova Scotia Health Authority
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Intervention model description

Participants will complete a minimum of 5 and a maximum of 17 one-on-one sessions (1-1.5 hrs in length) with an Occupational Therapist throughout the CR program. This program is designed to be tailored to a participant's individual needs, focusing on their specific cognitive impairments (hence the large range of potential sessions). During these sessions, participants will work with their clinician to learn compensatory strategies and restoration of cognition through a series of drill and practices to overcome their cognitive challenges. This study will use a mixed methods design incorporating both qualitative and quantitative research methods. Upon completion of the program, participants will be asked to complete a one-on-one interview with a researcher lasting approximately one hour. Additionally, participants will complete two psychometric questionnaires before beginning the cognitive remediation program and upon completion of the program.

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Participant Reported Qualitative ExperienceFrom 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

MeasureTime frameDescription
1. Repeatable Battery for the Assessment of Neuropsychological Status Update (RBANS)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.
World Health Organization Disability Assessment Schedule 2.0 (WHODAS)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.
Patient Health Questionnaire 9 Item (PHQ-9)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.
Generalized Anxiety Disorder 7 Item (GAD-7)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.
Montreal Cognitive AssessmentFrom 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.

Contacts

Primary ContactAbraham Rudnick, MD, PhD, MPsych, BMedSc
abraham.rudnick@nshealth.ca902-460-6225
Backup ContactDougal M Nolan, MsC
dougal.nolan@nshealth.ca902-219-0893

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026