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Completed

NCT Number: NCT04681742

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.

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Key information

Age range

18 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

CO-OP Group

Behavioral

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.

Primary outcomes

  1. Client Satisfaction Questionnaire-8

    Time frame: post-intervention only (10 weeks post-baseline)

    Self-report, 8 item measures of intervention acceptability

  2. recruitment rate

    Time frame: calculated at end of intervention (10 weeks post-baseline)

    number enrolled/numberscreened AND Total # enrolled

  3. retention rate

    Time frame: calculated at end of intervention (10 weeks post-baseline)

    number completing study procedures/number enrolled

  4. adherence rate

    Time frame: calculated at end of intervention (10 weeks post-baseline)

    number of sessions attended/Total number of sessions

  5. assessment battery feasibility

    Time frame: calculated at end of intervention (10 weeks post-baseline)

    Time for completion

  6. assessment battery feasibility

    Time frame: calculated at end of intervention (10 weeks post-baseline)

    Percentage of assessment items complete

Secondary outcomes

  1. Canadian Occupation Performance Measure (COPM)

    Time frame: 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.

  2. Neurobehavioral Symptom Inventory

    Time frame: 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.

  3. Pittsburgh Sleep Quality Index

    Time frame: Change from baseline to post-intervention (10 weeks)

    Self-report measure of quality and patterns of sleep using a four point Likert scale

  4. Henry Ford Hospital Headache Disability Inventory

    Time frame: Change from baseline to post-intervention (10 weeks)

    Self-report questionnaire of functional impact of headache symptoms

  5. College of Optometrists in Vision Quality of Life Outcomes Assessment (COVD-QOL)

    Time frame: Change from baseline to post-intervention (10 weeks)

    Self-report measure of functional impact of visual impairments using a five point Likert scale

  6. Dysexecutive Questionnaire

    Time frame: Change from baseline to post-intervention (10 weeks)

    Self-report measure functional impact of dysexecutive symptoms using five point Likert scale.

  7. NIH Toolbox Cognition Battery

    Time frame: 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)

  8. Weekly Calendar Planning Assessment

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

University of Missouri-Columbia

Other

Registry information

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Dec 23, 2020
Registry last updated
Mar 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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