(Neuro)Cognitive Remediation for Adults With OSIs

Official title

(Neuro)Cognitive Remediation for Adults With Operational Stress Injuries

Overview

(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

Primary outcome measures

• Participant Reported Qualitative Experience [Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.]

Secondary outcome measures (5)

• 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.]
• World Health Organization Disability Assessment Schedule 2.0 (WHODAS) [Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.]
• Patient Health Questionnaire 9 Item (PHQ-9) [Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.]
• Generalized Anxiety Disorder 7 Item (GAD-7) [Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.]
• Montreal Cognitive Assessment [Time frame: From enrollment to the end of treatment- up to 17 weeks after enrollment.]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

N/A

Model

Single group

Masking

Open label

Primary purpose

Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Publications

• 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
• 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
• 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
• 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
• 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
• 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
• 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

Identifiers

NCT: NCT06813378 · 65194

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗