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Behavioural Intervention

Telehealth for Concussion (STAR-C Trial)

N/A
Waitlist Available
Led By Doug B Cooper, PhD
Research Sponsored by South Texas Veterans Health Care System
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up treatment session 1(week 1), treatment session 2 (week 1), last treatment session(week 3), 1 week post-treatment, 3 months post-treatment
Awards & highlights

STAR-C Trial Summary

This trial will analyze manualized treatments from a successful cognitive rehabilitation intervention to develop a streamlined version that is more feasible for Veterans and Service Members with TBI.

Eligible Conditions
  • Concussion

STAR-C Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~treatment session 1(week 1), treatment session 2 (week 1), last treatment session(week 3), 1 week post-treatment, 3 months post-treatment
This trial's timeline: 3 weeks for screening, Varies for treatment, and treatment session 1(week 1), treatment session 2 (week 1), last treatment session(week 3), 1 week post-treatment, 3 months post-treatment for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Common Concussive Cognitive Complaints (C4) Inventory Change
Goal Attainment Scaling Change
Key Behaviors Change Inventory (KBCI)
+2 more
Secondary outcome measures
Acceptability of Intervention Measure (AIM)- (Clinician)
Acceptability of Intervention Measure (AIM)- (Patient)
Center for Epidemiological Studies-Depression (CES-D)
+5 more

STAR-C Trial Design

2Treatment groups
Experimental Treatment
Group I: TelehealthExperimental Treatment1 Intervention
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered via telehealth.
Group II: In-PersonExperimental Treatment1 Intervention
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) delivered face-to-face.

Find a Location

Who is running the clinical trial?

South Texas Veterans Health Care SystemLead Sponsor
18 Previous Clinical Trials
6,035 Total Patients Enrolled
Brooke Army Medical CenterFED
117 Previous Clinical Trials
26,436 Total Patients Enrolled
McMaster UniversityOTHER
877 Previous Clinical Trials
2,596,002 Total Patients Enrolled

Media Library

Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) (Behavioural Intervention) Clinical Trial Eligibility Overview. Trial Name: NCT05091970 — N/A
Concussion Research Study Groups: Telehealth, In-Person
Concussion Clinical Trial 2023: Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) Highlights & Side Effects. Trial Name: NCT05091970 — N/A
Manualized cognitive rehabilitation for mild traumatic brain injury (mTBI) (Behavioural Intervention) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05091970 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

How many participants are taking part in this clinical research endeavor?

"Affirmative. Clinicaltrials.gov contains data which indicates that this clinical trial, first posted on November 10th 2021, is actively seeking participants. 75 individuals are being sought after from 2 separate medical centres."

Answered by AI

What is the purpose of this experiment?

"The primary outcome of this clinical trial, to be monitored throughout Baseline; 1 week post-treatment, 4 weeks post-treatment and 12 weeks post-treatment is Goal Attainment Scaling Change. Additionally, Feasibility of Intervention Measure (FIM), PTSD Checklist 5 (PCL-5) and Epworth Sleepiness Scale - Adult Version (ESS) are secondary measures that will be taken into account. FIM comprises four items rated on a five point Likert scale representing complete disagreement to total agreement respectively. PCL-5 scores range from 0 to 80 with higher values indicating greater presence and intensity of symptoms. Lastly"

Answered by AI

Is this experiment in need of participants?

"As per the information listed on clinicaltrials.gov, this trial commenced recruitment on November 10th 2021 and is currently recruiting participants. The most recent update was posted on May 12th 2022."

Answered by AI

How can I become eligible to participate in this research project?

"Eligibility requirements for this brain concussion trial include a patient's age being between 18 and 65. A total of 75 individuals will be admitted into the study."

Answered by AI

Does this clinical research accept applicants aged 18 or above?

"This clinical trial requires that all participants be no younger than 18 and not older than 65."

Answered by AI
Recent research and studies
~17 spots leftby Mar 2025