Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome
- Conditions
- Brain ConcussionPost-Concussion Syndrome
- Interventions
- Behavioral: CO-OP Group
- Registration Number
- NCT04681742
- Lead Sponsor
- University of Missouri-Columbia
- Brief Summary
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
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 15
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description CO-OP Group CO-OP Group 10, 45-60 minute Cognitive Orientation to daily Occupational Performance intervention sessions
- Primary Outcome Measures
Name Time Method recruitment rate calculated at end of intervention (10 weeks post-baseline) number enrolled/numberscreened AND Total # enrolled
retention rate calculated at end of intervention (10 weeks post-baseline) number completing study procedures/number enrolled
adherence rate calculated at end of intervention (10 weeks post-baseline) number of sessions attended/Total number of sessions
Client Satisfaction Questionnaire-8 post-intervention only (10 weeks post-baseline) Self-report, 8 item measures of intervention acceptability
assessment battery feasibility calculated at end of intervention (10 weeks post-baseline) Percentage of assessment items complete
- Secondary Outcome Measures
Name Time Method College of Optometrists in Vision Quality of Life Outcomes Assessment (COVD-QOL) Change from baseline to post-intervention (10 weeks) Self-report measure of functional impact of visual impairments using a five point Likert scale
Dysexecutive Questionnaire Change from baseline to post-intervention (10 weeks) Self-report measure functional impact of dysexecutive symptoms using five point Likert scale.
NIH Toolbox Cognition Battery Change from baseline to post-intervention (10 weeks) 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)
Henry Ford Hospital Headache Disability Inventory Change from baseline to post-intervention (10 weeks) Self-report questionnaire of functional impact of headache symptoms
Canadian Occupation Performance Measure (COPM) Change from baseline to post-intervention (10 weeks) Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale.
Weekly Calendar Planning Assessment Change from baseline to post-intervention (10 weeks) Performance-based measure of executive functioning within a calendar planning activity using accuracy and time to completion scores. Alternate forms available.
Neurobehavioral Symptom Inventory Change from baseline to post-intervention (10 weeks) Self-report measure on the severity and impact of common concussive symptoms using a 0 (none) to 4 (very severe) Likert scale.
Pittsburgh Sleep Quality Index Change from baseline to post-intervention (10 weeks) Self-report measure of quality and patterns of sleep using a four point Likert scale
Trial Locations
- Locations (1)
University of Missouri-Columbia
🇺🇸Columbia, Missouri, United States