CLINICAL TRIAL

Resilience/Adjustment Counseling with Booster Sessions for Brain Injuries, Traumatic

Recruiting · 18+ · All Sexes · Midlothian, VA

Intervention to Promote Survivor Resilience and Adjustment: Efficacy and Sustainability

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About the trial for Brain Injuries, Traumatic

Eligible Conditions
Brain Injuries · Brain Injuries, Traumatic · Traumatic Brain Injury (TBI)

Treatment Groups

This trial involves 2 different treatments. Resilience/Adjustment Counseling With Booster Sessions 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.
Resilience/Adjustment Counseling with Booster Sessions
BEHAVIORAL
Control TreatmentAnother portion of participants receive the standard treatment to act as a baseline.
Resilience/Adjustment Counseling
BEHAVIORAL

Eligibility

This trial is for patients born any sex aged 18 and older. There are 2 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Mild, moderate, or severe TBI defined as: damage to brain tissue caused by an external mechanical force as evidenced by loss of consciousness due to brain trauma, post-traumatic amnesia (PTA), skull fracture, or objective neurological findings that can be reasonably attributed to TBI on physical examination or mental status examination.
At least 3 months post-TBI.
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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: Change from Baseline to Follow-Up (11 months after Baseline)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: Change from Baseline to Follow-Up (11 months after Baseline).
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 Resilience/Adjustment Counseling with Booster Sessions will improve 1 primary outcome and 3 secondary outcomes in patients with Brain Injuries, Traumatic. Measurement will happen over the course of Change from Baseline to Follow-Up (11 months after Baseline).

13 Item Stress Test
CHANGE FROM BASELINE TO FOLLOW-UP (11 MONTHS AFTER BASELINE)
This self-report measure was developed more than a decade ago for clinical research studies on stress management with survivors and caregiving family members. Sample items include, "I have more to do than I can handle," "I'm pushing myself too hard," and "I can't stand living like this." Items are rated as True (+1) or False (0) with higher scores indicating higher stress levels. The measure has been shown to be sensitive to family intervention after TBI.63,64 The Total Score is the measure of interest in the present investigation.
Brief Symptom Inventory-18 (BSI-18)
CHANGE FROM BASELINE TO FOLLOW-UP (11 MONTHS AFTER BASELINE)
This 18-item self-report instrument was developed to quantify psychological distress in the general population. A number of investigators have used the measure to quantify distress after TBI. In particular, researchers have used the BSI to monitor change in psychological status in response to treatment and general change in status over time. The BSI-18 is often used because of its sound psychometric properties, brevity, ease of administration, and global assessment of psychological issues commonly found in individuals with TBI. Frequency ratings for items in three primary symptom dimensions (Somatization, Depression, and Anxiety) are added to yield the Global Severity Index (GSI). T-scores are calculated based on community norms. The GSI score reflects the overall distress level and is the focus of the present investigation.
Mayo Portland Adaptability Inventory-4 (MPAI-4)
CHANGE FROM BASELINE TO FOLLOW-UP (11 MONTHS AFTER BASELINE)
The MPAI-4 is comprised of 30 items rated from 0 - 4 with higher scores indicating greater problem severity. Items are subdivided into three subscales reflecting emotional and behavioral self-regulation (Adjustment Index), cognitive and physical abilities (Ability Index), and community integration (Participation Index). T-scores are obtained based on norms derived from a brain injury sample. The present investigation focuses on the former two subscales. Adjustment Index items relate to anxiety, depression, irritability, anger, social interaction, and self-awareness. The Ability Index includes items relating to verbal and nonverbal communication and problem solving ability. Research has provided evidence of good concurrent, construct, and predictive validity as well as satisfactory internal consistency. Sensitivity to treatment-related change has also been substantiated.
Connor-Davidson Resilience Scale-10 (CD-RISC-10)
CHANGE FROM BASELINE TO FOLLOW-UP (11 MONTHS AFTER BASELINE)
During the past decade, researchers have developed resilience measurement scales, and a recent review suggested that Connor and Davidson have been most successful. The authors first developed a 25 item scale (CD-RISC) reflecting resilience characteristics identified by Kobasa and Rutter. Normative studies including factor analyses indicated that the CD-RISC is reliable, valid, and sensitive to treatment effects. More recently, a 10-item version was developed using exploratory and confirmatory factors analyses. Respondents are presented with a series of descriptors (e.g., "I am able to adapt and change," "Coping with stress can strengthen me") and rate themselves on a 0 - 4 scale ranging from rarely true (0) to true nearly all the time (4). Campbell-Sills and colleagues have characterized the 10-item version, used in the present study, as demonstrating excellent psychometric properties, namely reliability, internal consistency, and construct validity.

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 the signs of brain injuries, traumatic?

Many of the head injuries are asymptomatic. A significant number of penetrating injuries and brainstem injuries are associated with persistent headache. These observations are helpful for early identification of injuries and development of a management plan.

Anonymous Patient Answer

What is brain injuries, traumatic?

Traumatic brain injury (TBI) is a frequent and disabling problem for all of medical specialties. Traumatic brain injuries constitute a leading cause of injury-inflicted disability in the US, accounting for 1 billion cases annually. Injury-related functional disability results in prolonged hospitalization, a reduction in employment, and other lasting social and psychological problems. This article presents an overview of the physical and mental sequelae, and prevention of traumatic brain injury.

Anonymous Patient Answer

What are common treatments for brain injuries, traumatic?

Most people with traumatic brain injuries need some form of medical, physical or psychological help. The benefits of early and effective intervention for these injuries are critical to their long term outcome.

Anonymous Patient Answer

How many people get brain injuries, traumatic a year in the United States?

About 33.4 million U.S. people had some sort of [traumatic brain injury](https://www.withpower.com/clinical-trials/traumatic-brain-injury) and about 3.2 million people sustained one in 2016. TBIs result in moderate-to-severe disability in the United States. A number of high-risk factors for TBIs have been identified, including age and gender. TBIs resulting in amputation occurred to 324,000 people in 2016. Rates of TBIs continue to rise.

Anonymous Patient Answer

Can brain injuries, traumatic be cured?

While most brain injuries, traumatic can be cured, it is unclear with patients who are medically intact to what extent the injury occurred post-injury. Because many individuals, who are medically intact have healed their brain injuries, they may have benefited from treatment or intervention, and further research is needed to examine which treatments work to cure brain injuries, traumatic.

Anonymous Patient Answer

What causes brain injuries, traumatic?

Traumatic brain injuries are very common, and most accidents happen as the result of violence. Brain injuries are associated with trauma, accidents in roads and cars and the lack of protective measures of the car. Traumatic brain injury is also a result of accidents in and outdoors activities. Prevention of the incidence and consequences can be made by improving the availability and quality of protective clothes.

Anonymous Patient Answer

Has resilience/adjustment counseling with booster sessions proven to be more effective than a placebo?

The study found that a one-session intervention with booster sessions to survivors of rape/spousal abuse has proven to be more effective in reducing PTSD symptomology than in a control condition.

Anonymous Patient Answer

Is resilience/adjustment counseling with booster sessions typically used in combination with any other treatments?

Recent findings suggest that resilience-based interventions, when combined with treatment for PTSD, are effective for improving HRQoL, psychological well-being, and health-related quality of life in persons with moderate-to-severe TBI who are receiving current psychosocial treatment, and that booster sessions are associated with greater improvement of HRQoL after TBI than is treatment for only TBI symptoms only.

Anonymous Patient Answer

How does resilience/adjustment counseling with booster sessions work?

Recent findings provided preliminary evidence to support the effectiveness of a brief 10-session, low-intensity resilience/adjustment intervention for young to middle age adults following a traumatic event. Additional research with larger sample sizes is warranted.

Anonymous Patient Answer

What is the average age someone gets brain injuries, traumatic?

The mean age at traumatic injury was 14 yrs and 8-44 yrs in males and females respectively. Injury related behaviors were the leading causes of traumatic brain injury. A majority of the traumatic brain injury (TBI) resulted in coma, while a large percentage of comatose patients did not regain consciousness. The most frequent injury occurred between 9 a.m. and 5 p.m., with one of the leading causes of death being TBI. TBI occurred in all racial groups and were more common in older patients. In the absence of specific prevention or intervention measures, it can be expected that TBI will decrease in the future and the number of deaths due to TBI will be less than before.

Anonymous Patient Answer

What does resilience/adjustment counseling with booster sessions usually treat?

This intervention improved health literacy, social competence skill, and functional skills, but it was not associated with behavioral and physiological changes after traumatic brain injury that could inform the trajectory of recovery trajectories. Further research with a larger sample size, better quality control, and more sensitive measures is needed to compare the effects of various resilience interventions.

Anonymous Patient Answer

What are the common side effects of resilience/adjustment counseling with booster sessions?

In a recent study, findings suggest that resilience/adjustment counseling with booster sessions is effective in enhancing the resilience and well-being of children and adolescents. Resilience counseling may lead to a greater probability that students will be successful in coping with stressful and challenging environmental circumstances when confronted with adversity. More research is necessary to validate this approach and help physicians and other healthcare providers who deliver resilience education services.

Anonymous Patient Answer
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