Clinical trial NCT04681742: Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome
Official title: Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Brain Concussion
Post-Concussion Syndrome
Keywords: metacognition
occupational therapy
Lead sponsor: University of Missouri-Columbia
Sponsor class: OTHER
First posted: 2020-12-23
Enrollment: 15
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Client Satisfaction Questionnaire-8
timeFrame: post-intervention only (10 weeks post-baseline)
measure: recruitment rate
timeFrame: calculated at end of intervention (10 weeks post-baseline)
measure: retention rate
timeFrame: calculated at end of intervention (10 weeks post-baseline)
measure: adherence rate
timeFrame: calculated at end of intervention (10 weeks post-baseline)
measure: assessment battery feasibility
timeFrame: calculated at end of intervention (10 weeks post-baseline)
measure: assessment battery feasibility
timeFrame: calculated at end of intervention (10 weeks post-baseline)
Secondary outcomes:
measure: Canadian Occupation Performance Measure (COPM)
timeFrame: Change from baseline to post-intervention (10 weeks)
measure: Neurobehavioral Symptom Inventory
timeFrame: Change from baseline to post-intervention (10 weeks)
measure: Pittsburgh Sleep Quality Index
timeFrame: Change from baseline to post-intervention (10 weeks)
measure: Henry Ford Hospital Headache Disability Inventory
timeFrame: Change from baseline to post-intervention (10 weeks)
measure: College of Optometrists in Vision Quality of Life Outcomes Assessment (COVD-QOL)
timeFrame: Change from baseline to post-intervention (10 weeks)
measure: Dysexecutive Questionnaire
timeFrame: Change from baseline to post-intervention (10 weeks)
measure: NIH Toolbox Cognition Battery
timeFrame: Change from baseline to post-intervention (10 weeks)
measure: Weekly Calendar Planning Assessment
timeFrame: Change from baseline to post-intervention (10 weeks)
Other outcomes:
Locations:
city: Columbia
country: United States
facility: University of Missouri-Columbia
state: Missouri
Study officials:
affiliation: University of Missouri-Columbia
name: Anna Boone, PhD
role: PRINCIPAL_INVESTIGATOR
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