An interventional study of CO-OP Group in Brain Concussion and Post-Concussion Syndrome, sponsored by University of Missouri-Columbia. Completed at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2023-03-10.
Sponsored by University of Missouri-Columbia · Not applicable, Interventional, and Treatment
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.
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.
132 studies on the registry are indexed under Post-Concussion Syndrome; 33 are open to participants now.
This study's enrollment of 15 is below the median of 52 across 110 interventional studies indexed under Post-Concussion Syndrome.
Browse Post-Concussion Syndrome studies →University of Missouri-Columbia is the lead sponsor of 357 studies on the registry; 70 are open to participants now.
Of its 42 completed or terminated interventional studies of FDA-regulated products, 28 (67%) have results posted.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
10, 45-60 minute Cognitive Orientation to daily Occupational Performance intervention sessions
Behavioral: CO-OP Group
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.
Client Satisfaction Questionnaire-8
Self-report, 8 item measures of intervention acceptability
Time frame: post-intervention only (10 weeks post-baseline)
recruitment rate
number enrolled/numberscreened AND Total # enrolled
Time frame: calculated at end of intervention (10 weeks post-baseline)
retention rate
number completing study procedures/number enrolled
Time frame: calculated at end of intervention (10 weeks post-baseline)
adherence rate
number of sessions attended/Total number of sessions
Time frame: calculated at end of intervention (10 weeks post-baseline)
assessment battery feasibility
Time for completion
Time frame: calculated at end of intervention (10 weeks post-baseline)
assessment battery feasibility
Percentage of assessment items complete
Time frame: calculated at end of intervention (10 weeks post-baseline)
Canadian Occupation Performance Measure (COPM)
Self-report measures of perceived performance and satisfaction of occupational performance on a 1 to 10 Likert scale.
Time frame: 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.
Time frame: 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
Time frame: Change from baseline to post-intervention (10 weeks)
Henry Ford Hospital Headache Disability Inventory
Self-report questionnaire of functional impact of headache symptoms
Time frame: 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
Time frame: Change from baseline to post-intervention (10 weeks)
Dysexecutive Questionnaire
Self-report measure functional impact of dysexecutive symptoms using five point Likert scale.
Time frame: 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)
Time frame: 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.
Time frame: Change from baseline to post-intervention (10 weeks)
This study is completed, as verified in Mar 2023. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
University of Missouri-Columbia