Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome

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.

Study Overview

• Status: Completed
• Conditions: Brain Concussion; Post-Concussion Syndrome
• Intervention / Treatment: Behavioral: CO-OP Group

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.

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Anna Boone, PhD, MSOT, OTR/L; Phone Number: 573-882-7023; Email: booneae@health.missouri.edu

Study Locations

• United States
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri-Columbia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 60 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: CO-OP Group; 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.

What is the study measuring?

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)

Collaborators and Investigators

• Sponsor: University of Missouri-Columbia
• Investigators: Principal Investigator: Anna Boone, PhD, University of Missouri-Columbia

Publications and helpful links

General Publications

• Kroenke K, Spitzer RL, Williams JB. The PHQ-9: validity of a brief depression severity measure. J Gen Intern Med. 2001 Sep;16(9):606-13. doi: 10.1046/j.1525-1497.2001.016009606.x.
• Attkisson CC, Zwick R. The client satisfaction questionnaire. Psychometric properties and correlations with service utilization and psychotherapy outcome. Eval Program Plann. 1982;5(3):233-7. doi: 10.1016/0149-7189(82)90074-x.
• Lundin A, de Boussard C, Edman G, Borg J. Symptoms and disability until 3 months after mild TBI. Brain Inj. 2006 Jul;20(8):799-806. doi: 10.1080/02699050600744327.
• McCrory P, Meeuwisse WH, Aubry M, Cantu RC, Dvorak J, Echemendia RJ, Engebretsen L, Johnston K, Kutcher JS, Raftery M, Sills A, Benson BW, Davis GA, Ellenbogen R, Guskiewicz KM, Herring SA, Iverson GL, Jordan BD, Kissick J, McCrea M, McIntosh AS, Maddocks D, Makdissi M, Purcell L, Putukian M, Schneider K, Tator CH, Turner M. Consensus statement on concussion in sport: the 4th International Conference on Concussion in Sport, Zurich, November 2012. J Athl Train. 2013 Jul-Aug;48(4):554-75. doi: 10.4085/1062-6050-48.4.05. No abstract available.
• Law M, Baptiste S, McColl M, Opzoomer A, Polatajko H, Pollock N. The Canadian occupational performance measure: an outcome measure for occupational therapy. Can J Occup Ther. 1990 Apr;57(2):82-7. doi: 10.1177/000841749005700207.
• Jacobson GP, Ramadan NM, Aggarwal SK, Newman CW. The Henry Ford Hospital Headache Disability Inventory (HDI). Neurology. 1994 May;44(5):837-42. doi: 10.1212/wnl.44.5.837.
• Dawson DR, Binns MA, Hunt A, Lemsky C, Polatajko HJ. Occupation-based strategy training for adults with traumatic brain injury: a pilot study. Arch Phys Med Rehabil. 2013 Oct;94(10):1959-63. doi: 10.1016/j.apmr.2013.05.021. Epub 2013 Jun 22.
• Polatajko HJ, McEwen SE, Ryan JD, Baum CM. Pilot randomized controlled trial investigating cognitive strategy use to improve goal performance after stroke. Am J Occup Ther. 2012 Jan-Feb;66(1):104-9. doi: 10.5014/ajot.2012.001784.
• McEwen S, Polatajko H, Baum C, Rios J, Cirone D, Doherty M, Wolf T. Combined Cognitive-Strategy and Task-Specific Training Improve Transfer to Untrained Activities in Subacute Stroke: An Exploratory Randomized Controlled Trial. Neurorehabil Neural Repair. 2015 Jul;29(6):526-36. doi: 10.1177/1545968314558602. Epub 2014 Nov 21.
• Henshaw E, Polatajko H, McEwen S, Ryan JD, Baum CM. Cognitive approach to improving participation after stroke: two case studies. Am J Occup Ther. 2011 Jan-Feb;65(1):55-63. doi: 10.5014/ajot.2011.09010.
• Dawson DR, Gaya A, Hunt A, Levine B, Lemsky C, Polatajko HJ. Using the cognitive orientation to occupational performance (CO-OP) with adults with executive dysfunction following traumatic brain injury. Can J Occup Ther. 2009 Apr;76(2):115-27. doi: 10.1177/000841740907600209.
• Bergersen K, Halvorsen JO, Tryti EA, Taylor SI, Olsen A. A systematic literature review of psychotherapeutic treatment of prolonged symptoms after mild traumatic brain injury. Brain Inj. 2017;31(3):279-289. doi: 10.1080/02699052.2016.1255779. Epub 2017 Jan 26.
• Schmitter-Edgecombe M, Seelye AM. Recovery of content and temporal order memory for performed activities following moderate to severe traumatic brain injury. J Clin Exp Neuropsychol. 2012;34(3):256-68. doi: 10.1080/13803395.2011.633497. Epub 2012 Jan 6.
• Taylor CA, Bell JM, Breiding MJ, Xu L. Traumatic Brain Injury-Related Emergency Department Visits, Hospitalizations, and Deaths - United States, 2007 and 2013. MMWR Surveill Summ. 2017 Mar 17;66(9):1-16. doi: 10.15585/mmwr.ss6609a1.
• Jagoda AS, Bazarian JJ, Bruns JJ Jr, Cantrill SV, Gean AD, Howard PK, Ghajar J, Riggio S, Wright DW, Wears RL, Bakshy A, Burgess P, Wald MM, Whitson RR. Clinical policy: neuroimaging and decisionmaking in adult mild traumatic brain injury in the acute setting. J Emerg Nurs. 2009 Apr;35(2):e5-40. doi: 10.1016/j.jen.2008.12.010.
• King PR, Donnelly KT, Donnelly JP, Dunnam M, Warner G, Kittleson CJ, Bradshaw CB, Alt M, Meier ST. Psychometric study of the Neurobehavioral Symptom Inventory. J Rehabil Res Dev. 2012;49(6):879-88. doi: 10.1682/jrrd.2011.03.0051.
• Carpenter JS, Andrykowski MA. Psychometric evaluation of the Pittsburgh Sleep Quality Index. J Psychosom Res. 1998 Jul;45(1):5-13. doi: 10.1016/s0022-3999(97)00298-5.
• Carlozzi NE, Tulsky DS, Wolf TJ, Goodnight S, Heaton RK, Casaletto KB, Wong AWK, Baum CM, Gershon RC, Heinemann AW. Construct validity of the NIH Toolbox Cognition Battery in individuals with stroke. Rehabil Psychol. 2017 Nov;62(4):443-454. doi: 10.1037/rep0000195.
• Weiner NW, Toglia J, Berg C. Weekly Calendar Planning Activity (WCPA): a performance-based assessment of executive function piloted with at-risk adolescents. Am J Occup Ther. 2012 Nov-Dec;66(6):699-708. doi: 10.5014/ajot.2012.004754.
• Bennett PC, Ong B, Ponsford J. Measuring executive dysfunction in an acute rehabilitation setting: using the dysexecutive questionnaire (DEX). J Int Neuropsychol Soc. 2005 Jul;11(4):376-85. doi: 10.1017/s1355617705050423.
• Maples WC, Hoenes R. The College of Optometrists in Vision Development checklist related to vision function: expert opinions. Optometry. 2009 Dec;80(12):688-94. doi: 10.1016/j.optm.2009.06.003.
• Ferreira IS, Pinto CB, Saleh Velez FG, Leffa DT, Vulcano de Toledo Piza P, Fregni F. Recruitment challenges in stroke neurorecovery clinical trials. Contemp Clin Trials Commun. 2019 Jul 5;15:100404. doi: 10.1016/j.conctc.2019.100404. eCollection 2019 Sep. Erratum In: Contemp Clin Trials Commun. 2020 Dec 10;20:100689.
• French B, Leathley M, Sutton C, McAdam J, Thomas L, Forster A, Langhorne P, Price C, Walker A, Watkins C. A systematic review of repetitive functional task practice with modelling of resource use, costs and effectiveness. Health Technol Assess. 2008 Jul;12(30):iii, ix-x, 1-117. doi: 10.3310/hta12300.
• Waljas M, Iverson GL, Lange RT, Hakulinen U, Dastidar P, Huhtala H, Liimatainen S, Hartikainen K, Ohman J. A prospective biopsychosocial study of the persistent post-concussion symptoms following mild traumatic brain injury. J Neurotrauma. 2015 Apr 15;32(8):534-47. doi: 10.1089/neu.2014.3339. Epub 2015 Feb 25.

Study record dates

Study Major Dates

• Study Start (Actual): October 15, 2020
• Primary Completion (Actual): December 31, 2022
• Study Completion (Actual): December 31, 2022

Study Registration Dates

• First Submitted: December 16, 2020
• First Submitted That Met QC Criteria: December 18, 2020
• First Posted (Actual): December 23, 2020

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 8, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: occupational therapy; metacognition
• Additional Relevant MeSH Terms: Pathologic Processes; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Disease; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds, Nonpenetrating; Brain Injuries; Brain Injuries, Traumatic; Syndrome; Post-Concussion Syndrome; Brain Concussion
• Other Study ID Numbers: 2019802

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No