CLINICAL TRIAL

Psychological Intervention for Post-Concussion Syndrome

Recruiting · < 65 · All Sexes · Los Angeles, CA

This study is evaluating whether a brief psychological intervention may help reduce post-concussion symptoms.

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About the trial for Post-Concussion Syndrome

Eligible Conditions
Post-Concussion Syndrome · Brain Concussion · Mild Traumatic Brain Injury (MTBI) · Brain Injuries, Traumatic · Post Concussion Syndrome · Brain Injuries

Treatment Groups

This trial involves 2 different treatments. Psychological Intervention is the primary treatment being studied. Participants will all receive the same treatment. There is no placebo group. The treatments being tested are not being studied for commercial purposes.

Main TreatmentA portion of participants receive this new treatment to see if it outperforms the control.
Psychological Intervention
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Psychological Intervention
2019
N/A
~100

Eligibility

This trial is for patients born any sex aged 65 and younger. There are 4 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Between the ages of 13-25
Diagnosed with a concussion or mild traumatic brain injury by a physician
Currently experiencing post-concussive symptoms for at least two months after their injury but no longer than 9 months.
Fluent English speaker
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: baseline and 6 weeks
Screening: ~3 weeks
Treatment: Varies
Reporting: baseline and 6 weeks
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: baseline and 6 weeks.
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether Psychological Intervention will improve 2 primary outcomes, 6 secondary outcomes, and 9 other outcomes in patients with Post-Concussion Syndrome. Measurement will happen over the course of baseline and 6 weeks.

Change in perceived cognitive exertion after treatment
BASELINE AND 6 WEEKS
Change in self-reported physical, emotional, and perceived cognitive symptoms from pre- to post-neurocognitive assessment.
BASELINE AND 6 WEEKS
Change in anxiety symptoms after treatment
BASELINE AND 6 WEEKS
Self-report measure of cognitive and somatic symptoms of anxiety, Beck Anxiety Inventory (BAI)
BASELINE AND 6 WEEKS
Change in end-tidal carbon dioxide after treatment
BASELINE AND 6 WEEKS
Changes in end-tidal carbon dioxide measurement in response to stress paradigm measured through capnometer in mmHg
BASELINE AND 6 WEEKS
Change in depressive symptoms after treatment
BASELINE AND 6 WEEKS
Self-report measure of cognitive and somatic symptoms of depression, Beck Depression Inventory (BDI-II)
BASELINE AND 6 WEEKS
Change in disability perception due to injury after treatment
BASELINE AND 6 WEEKS
Change in self-reported disability in social, occupational, and family/home functioning as measured by the Sheehan Disability Scale
BASELINE AND 6 WEEKS
Change in orthostatic blood pressure after treatment
BASELINE AND 6 WEEKS
Change in orthostatic blood pressure obtained via measurements in three different positions: supine, upright sitting, and standing, each held for 5 minutes. Measurement obtained via Biopac double finger cuff.
BASELINE AND 6 WEEKS
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Who is running the study

Principal Investigator
R. F. A. P.
Robert F. Asarnow Ph.D, Study Principal Investigator
University of California, Los Angeles

Patient Q & A Section

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

What are common treatments for post-concussion syndrome?

There is not one treatment for post-concussion syndrome that is highly effective. Instead, treatments are tailored to the specific patient because there is a small percentage of patients who can benefit tremendously from treatment. Furthermore, there is not one treatment that has been proven to be effective for all patients. Treatment for post-concussion syndrome should be tailored to the specific patient based on their symptoms and the outcome the patient intends to achieve. This is a more effective treatment plan because the less that post-concussion syndrome sufferers experience, the less their symptoms will become worse. Because of this, more research is needed and it is necessary to evaluate medications and potential treatments before recommending an established treatment regimen.

Anonymous Patient Answer

Can post-concussion syndrome be cured?

Post-concussion Syndrome can be substantially reduced, even when the underlying condition like concussion is undiagnosed. It can not be cured, but it can be treated and most of the patients can return to their previous status within 6 months.

Anonymous Patient Answer

What are the signs of post-concussion syndrome?

Symptoms of PCS were widely variable among the sports-medicine participants in the study. The most common symptoms are headache, dizziness, loss of focus and confusion. Data from a recent study suggest that it is important to assess for symptoms of concussion in all clinical populations using similar criteria, such as the mSRC, when post-concussion syndrome is being investigated.

Anonymous Patient Answer

What causes post-concussion syndrome?

The post-concussion syndrome may be caused by many mechanisms and may not necessarily be due to one of the proposed causes (head injury, drug consumption, or psychological distress) of the syndrome.

Anonymous Patient Answer

How many people get post-concussion syndrome a year in the United States?

About 1.4 million people would develop symptoms of a post-concussion syndrome in 2022. This rate exceeds the 1.2 million new cases of post-concussion syndrome annually.

Anonymous Patient Answer

What is post-concussion syndrome?

In a recent study, findings do not indicate the presence of PCS after mild-to-moderate TBI (relative to controls), and the prevalence of mild PCS in people not using prescription or over-the-counter medications, as well as in the participants who did not report use of any prescription or over-the-counter medications, were extremely low. Further investigation is required to evaluate other potential contributors of post-concussion symptoms like anxiety and depression.

Anonymous Patient Answer

What are the latest developments in psychological intervention for therapeutic use?

It is clear that some treatments are superior to others, but there are a limited number of guidelines available to assist therapists in identifying the type of treatment that best suits individual cases. There are also significant limitations to our understanding of the mechanism by which treatments work and in a number of cases, it is unclear whether the findings translate to a better long-term outcome for our patients. There is some evidence that psychological interventions, including cognitive behavioural therapies, have had an effect on a range of physical and psychological outcomes such as risk profiles, treatment adherence, quality of life, and overall health, all of which may be more predictable for each patient than just dealing with psychosocial symptoms directly.

Anonymous Patient Answer

What is the average age someone gets post-concussion syndrome?

The average age of PPCS onset is approximately 46 years old for males and 43 years old for females. In the United States, post-concussion syndrome affects approximately 5% of young athletes, and PPCS causes a significant economic burden on the healthcare system. The average age of symptom onset is earlier than previously reported.

Anonymous Patient Answer

Is psychological intervention safe for people?

Psychological interventions could have a moderate positive effect for people with mild and moderate traumatic brain injury, however, they are not recommended as the current standard of care for this cohort. This trial was registered at www.anzctr.org.au (reference number: ACTRN12610000130036) as ACTRN12610000130034, and was accepted with no change in the recruitment target. summary: Data from a recent study is evaluating whether counseling to improve health behaviors will help patients with traumatic brain injury.

Anonymous Patient Answer

How serious can post-concussion syndrome be?

[The incidence of [PCS] is higher than previously reported from the general U.S. population, however; (it is less than 3% to 5%); there also appears to be an increase during the week following a concussion; and the time period of presentation ranges from a week following a concussion to 12 weeks after a concussion; however, only 15% of participants had PCS at 12 weeks after concussion. Although PCS could be considered an extremely debilitating symptom, it is also potentially reversible. For this reason, our results suggest that PCS may be less serious than previously reported. (https://www.withpower.

Anonymous Patient Answer

Is psychological intervention typically used in combination with any other treatments?

Findings support psychological treatment is typically used in conjunction with other treatments for chronic traumatic brain injury, and may indicate additional clinical benefit from the addition of neuropsychological assessments.

Anonymous Patient Answer

What is psychological intervention?

Although the literature on the topic of psychological intervention is rather vast, it is important to note that the most common interventions are carers and patient's social work/psychology (e.g., social skills, family and group interventions). These interventions are effective in [improving coping strategies (e.g., emotion regulation, stress management, and mental health) and function of the patient's life (e.g., daily functioning, relationships, and social support networks)].

Anonymous Patient Answer
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