Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome

Study Overview
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Brief Summary
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This study will evaluate the practicality (i.e. acceptability to stakeholders; outcome battery feasibility; recruitment, retention, and adherence rates) and the preliminary effect of a cognitive strategy training intervention in adults with post-concussive syndrome.

Detailed Description
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Up to 90% of known traumatic brain injuries are classified as mild, with many more injuries likely going undetected. While each of these individuals experiences somatic, cognitive, and/or affective symptoms acutely following the injury, an estimated 10-15% will continue to experience these symptoms for months up to a year post-injury. The persistence of symptoms for three months or greater is termed post-concussive syndrome (PCS) and can lead to decreases in academics, job performance, leisure, daily life activities, and routines. Traditionally, rehabilitation is either not provided to these individuals or has a specific focus on alleviating impairments (e.g. sustained attention) instead of mitigating effects on daily life function. Transfer of improvements in said impairments is known to be limited. Cognitive Orientation to daily Occupational Performance (CO-OP), a type of metacognitive strategy training, has known positive effects on activity performance outcomes in acquired brain injury (e.g. subacute and chronic stroke; moderate traumatic brain injury)1-5. CO-OP has yet to be evaluated in a sample of individuals with PCS. In sum, (1) CO-OP is an evidence-based intervention for improving activity performance, and (2) it is reasonable to hypothesize that the positive effects of CO-OP may be applied in PCS to overcome similar cognitive difficulties to improve activity performance. The central research hypothesis is that a functionally-oriented metacognitive strategy training intervention, CO-OP, will be feasible and have a positive effect on activity performance in individuals with PCS syndrome. A single-group, prospective design with outcomes gathered pre-and post-intervention will be used (n=15) to evaluate the acceptability and feasibility of CO-OP in PCS. We will also be evaluating effect size on outcome measures of activity performance and perceptions of the functional impact of PCS symptoms. Specific Aim 1: Determine the feasibility of CO-OP in Post-Concussive Syndrome. Hypothesis 1.1: Participants will report positive perceptions of the intervention via scores greater than 3 on the Client-Satisfaction Questionnaire. Hypothesis 1.2: The study will demonstrate acceptable recruitment, retention, and adherence rates. Hypothesis 1.3: The proposed assessment battery will be feasible (average completion time <2 hours). Specific Aim 2: Explore the preliminary effect of CO-OP in a sample of individuals with PCS on activity performance outcomes. Hypothesis 2.1: The CO-OP group will demonstrate improvements in activity performance outcomes.

Official Title
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Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome

Conditions
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Brain Concussion, Post-Concussion Syndrome

Intervention / Treatment
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* Behavioral: CO-OP Group


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants will be included if have a physician diagnosis of mTBI or if they meet the following criteria for mild traumatic brain injury established by the American Congress of rehabilitation Medicine including a traumatically induced physiological disruption of brain function, as manifested by at least one of the following: any loss of consciousness, any loss of memory for events immediately before or after the accident, any alteration in mental state at the time of the accident (e.g., feeling dazed, disoriented, or confused), and focal neurologic deficit(s) that may or may not be transient; severity of injury should not exceed a loss of consciousness >30 minutes, at 30 minutes post-injury a Glasgow Coma Scale score more severe than 13-15, or post-traumatic amnesia >24 hours. One or more post-concussive symptoms persisting for greater than 4 weeks that is inhibiting performance of one or more daily activities Age 18-60 years Exclusion Criteria: Any additional severe neurologic or psychiatric conditions severe depressive symptoms per a score of >21 on the Patient Health Questionnaire (PHQ-9) inability to read, write, and speak English fluently lack of transportation to intervention sessions

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CO-OP Group<br>10, 45-60 minute Cognitive Orientation to daily Occupational Performance intervention sessions | Behavioral: CO-OP Group<br>* CO-OP focuses on learning of a global problem-solving strategy, Goal-Plan-Do-Check (GPDC), within the performance of participant-chosen goals. Use of a broadly applicable strategy and meaningful activity ensures the intervention is salient to the participant and increases likelihood of transfer. Uniquely, therapists applying CO-OP use guided discovery methods, such as asking a series of probing questions, to support participants in analyzing their own performance of a given task and generating potential solutions for improving performance. Participants become equipped with these skills through repetitive application of the GPDC process. First, participants identify a specific goal (Goal). Then, participants consider a detailed plan (Plan) for accomplishing the goal. By carrying out the plan (Do) and critically analyzing the results (Check), participants determine how the plan worked. The intervention focuses on learning GPDC with gradual withdrawal of guided discovery methods.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Client Satisfaction Questionnaire-8 | Self-report, 8 item measures of intervention acceptability | post-intervention only (10 weeks post-baseline) | 
| recruitment rate | number enrolled/numberscreened AND Total # enrolled | calculated at end of intervention (10 weeks post-baseline) | 
| retention rate | number completing study procedures/number enrolled | calculated at end of intervention (10 weeks post-baseline) | 
| adherence rate | number of sessions attended/Total number of sessions | calculated at end of intervention (10 weeks post-baseline) | 
| assessment battery feasibility | Time for completion | calculated at end of intervention (10 weeks post-baseline) | 
| assessment battery feasibility | Percentage of assessment items complete | calculated at end of intervention (10 weeks post-baseline) | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Canadian Occupation Performance Measure (COPM) | Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale. | Change from baseline to post-intervention (10 weeks) | 
| Neurobehavioral Symptom Inventory | Self-report measure on the severity and impact of common concussive symptoms using a 0 (none) to 4 (very severe) Likert scale. | Change from baseline to post-intervention (10 weeks) | 
| Pittsburgh Sleep Quality Index | Self-report measure of quality and patterns of sleep using a four point Likert scale | Change from baseline to post-intervention (10 weeks) | 
| Henry Ford Hospital Headache Disability Inventory | Self-report questionnaire of functional impact of headache symptoms | Change from baseline to post-intervention (10 weeks) | 
| College of Optometrists in Vision Quality of Life Outcomes Assessment (COVD-QOL) | Self-report measure of functional impact of visual impairments using a five point Likert scale | Change from baseline to post-intervention (10 weeks) | 
| Dysexecutive Questionnaire | Self-report measure functional impact of dysexecutive symptoms using five point Likert scale. | Change from baseline to post-intervention (10 weeks) | 
| NIH Toolbox Cognition Battery | Neuropsychological, computer based tests of attention, executive functioning, episodic memory, working memory, language, and processing speed resulting in normative T-scores (mean=50; SD=10) | Change from baseline to post-intervention (10 weeks) | 
| Weekly Calendar Planning Assessment | Performance-based measure of executive functioning within a calendar planning activity using accuracy and time to completion scores. Alternate forms available. | Change from baseline to post-intervention (10 weeks) | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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metacognition, occupational therapy