(Neuro)Cognitive Remediation for Adults With OSIs

NCT06813378 | Not Yet Recruiting

• 1 other identifier: 65194
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

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.

Conditions

PTSD; Cognitive Impairment; Cognitive Dysfunction

Keywords

PTSD; Military; Veteran; Cognitive Remediation

Outcome Measures

Primary Outcomes (1)

• Participant Reported Qualitative Experience

  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.

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

Secondary Outcomes (5)

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

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

• World Health Organization Disability Assessment Schedule 2.0 (WHODAS)

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

• Patient Health Questionnaire 9 Item (PHQ-9)

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

• Generalized Anxiety Disorder 7 Item (GAD-7)

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

• Montreal Cognitive Assessment

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

Study Arms (1)

(Neuro)Cognitive Remediation

EXPERIMENTAL

Participants will undergo structured cognitive remediation program under the supervision of an Occupational Therapist. (Neuro)Cognitive Remediation will be achieved through teaching compensatory strategies, restoration of cognition through drill and practice and by utilizing regulative metacognitive strategies.

Behavioral: (Neuro)Cognitive Remediation

Interventions

(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.

(Neuro)Cognitive Remediation

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Participants must not:
• Be accessing CR treatment modality through an Occupational Therapist

Sponsors & Collaborators

• Nova Scotia Health Authority: lead

Related Publications (7)

• Best MW, Bowie CR. A review of cognitive remediation approaches for schizophrenia: from top-down to bottom-up, brain training to psychotherapy. Expert Rev Neurother. 2017 Jul;17(7):713-723. doi: 10.1080/14737175.2017.1331128. Epub 2017 May 24.

  PMID: 28511562 BACKGROUND

• Fonzo GA, Fine NB, Wright RN, Achituv M, Zaiko YV, Merin O, Shalev AY, Etkin A. Internet-delivered computerized cognitive & affective remediation training for the treatment of acute and chronic posttraumatic stress disorder: Two randomized clinical trials. J Psychiatr Res. 2019 Aug;115:82-89. doi: 10.1016/j.jpsychires.2019.05.007. Epub 2019 May 8.

  PMID: 31125916 BACKGROUND

• McClure MM, Graff FS, Triebwasser J, Perez-Rodriguez MM, Rosell DR, Szeszko PR, Chu KW, New AS, Siever LJ, Hazlett EA. Neuroimaging predictors of response to cognitive remediation and social skills training: A pilot study in veterans with schizophrenia. Psychiatry Res Neuroimaging. 2019 Nov 30;293:110988. doi: 10.1016/j.pscychresns.2019.110988. Epub 2019 Oct 8.

  PMID: 31655369 BACKGROUND

• Randolph C, Tierney MC, Mohr E, Chase TN. The Repeatable Battery for the Assessment of Neuropsychological Status (RBANS): preliminary clinical validity. J Clin Exp Neuropsychol. 1998 Jun;20(3):310-9. doi: 10.1076/jcen.20.3.310.823.

  PMID: 9845158 BACKGROUND

• Stevenson CS, Whitmont S, Bornholt L, Livesey D, Stevenson RJ. A cognitive remediation programme for adults with Attention Deficit Hyperactivity Disorder. Aust N Z J Psychiatry. 2002 Oct;36(5):610-6. doi: 10.1046/j.1440-1614.2002.01052.x.

  PMID: 12225443 BACKGROUND

• Twamley EW, Jak AJ, Delis DC, Bondi MW, Lohr JB. Cognitive Symptom Management and Rehabilitation Therapy (CogSMART) for veterans with traumatic brain injury: pilot randomized controlled trial. J Rehabil Res Dev. 2014;51(1):59-70. doi: 10.1682/JRRD.2013.01.0020.

  PMID: 24805894 BACKGROUND

• Vanderploeg RD, Cooper DB, Curtiss G, Kennedy JE, Tate DF, Bowles AO. Predicting treatment response to cognitive rehabilitation in military service members with mild traumatic brain injury. Rehabil Psychol. 2018 May;63(2):194-204. doi: 10.1037/rep0000215.

  PMID: 29878826 BACKGROUND

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic; Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders; Cognition Disorders; Neurocognitive Disorders

Central Study Contacts

Abraham Rudnick, MD, PhD, MPsych, BMedSc

CONTACT

902-460-6225; abraham.rudnick@nshealth.ca

Dougal M Nolan, MsC

CONTACT

902-219-0893; dougal.nolan@nshealth.ca

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Director- Nova Scotia Operational Stress Injury Clinic

Model Details: 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.

Study Record Dates

• First Submitted: January 31, 2025
• First Posted: February 7, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): December 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: June 8, 2025

Record last verified: 2025-06