Feasibility Testing of Cognitive Strategy Training in Post-Concussive Syndrome

NCT04681742 | Completed DMC

• 1 other identifier: 2019802
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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.

Conditions

Brain Concussion; Post-Concussion Syndrome

Keywords

metacognition; occupational therapy

Outcome Measures

Primary Outcomes (6)

• 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 Outcomes (8)

• Canadian Occupation Performance Measure (COPM)

  Change from baseline to post-intervention (10 weeks)

• Neurobehavioral Symptom Inventory

  Change from baseline to post-intervention (10 weeks)

• Pittsburgh Sleep Quality Index

  Change from baseline to post-intervention (10 weeks)

• Henry Ford Hospital Headache Disability Inventory

  Change from baseline to post-intervention (10 weeks)

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

  Change from baseline to post-intervention (10 weeks)

Study Arms (1)

CO-OP Group

EXPERIMENTAL

10, 45-60 minute Cognitive Orientation to daily Occupational Performance intervention sessions

Behavioral: CO-OP Group

Interventions

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.

CO-OP Group

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Missouri-Columbia: lead

Study Sites (1)

University of Missouri-Columbia

Columbia, Missouri, 65212, United States

Location

Related Publications (24)

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MeSH Terms

Conditions

Brain Concussion; Post-Concussion Syndrome

Condition Hierarchy (Ancestors)

Brain Injuries, Traumatic; Brain Injuries; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Head Injuries, Closed; Wounds and Injuries; Wounds, Nonpenetrating

Study Officials

• Anna Boone, PhD

  University of Missouri-Columbia

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor in the Department of Occupational Therapy

Study Record Dates

• First Submitted: December 16, 2020
• First Posted: December 23, 2020
• Study Start: October 15, 2020
• Primary Completion: December 31, 2022
• Study Completion: December 31, 2022
• Last Updated: March 10, 2023

Record last verified: 2023-03

Locations

US (1)