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| ID | Type | Description | Link |
|---|---|---|---|
| HT94252510889 | Other Grant/Funding Number | Department of Defense Office of the Congressionally Directed Medical Research Programs |
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| Name | Class |
|---|---|
| United States Department of Defense | FED |
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The purpose of the study is to test two different training programs to find out which is better at helping people with a concussion or mild TBI (mTBI) improve their emotional health and well-being. Study participation is completely remote and will last approximately 8 months total, involving 4 assessment visits and 8 sessions of brain training via a secure video-conferencing platform. The 4 assessment visits (about 30-90 minutes each) include surveys and questionnaires about participant's emotional health. These assessment visits will take place before the training, immediately after the training, 3 months after training and 6 months after training. The 8 sessions of 1-on-1 training (about 60-90 minutes each) will be completed over the course of approximately 1 month.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Program 1 | Experimental | Enhance emotional awareness and ability to name, describe and express emotions with greater clarity, granularity and accuracy. Goals include enhancing participants' ability to: recognize and embrace the benefits of emotional awareness; detect onset of emotional responses early before escalation; accurately label and differentiate emotions; discern emotions from non-emotions; recognize and experience a larger breadth of emotions, including pleasant emotions. |
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| Program 2 | Active Comparator | To promote general wellbeing and quality of life. Grounded in Health Belief Model emphasizing self-management and self-efficacy. Content includes topics relevant to living health with a TBI Contents were derived from the Traumatic Brain Injury Model Systems Knowledge Translation Center factsheets and topics recommended by the Consumer advisory panel. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Program 1 | Behavioral | Program 1 will teach participants how to recognize, label, and differentiate their emotions. The program will cover ways to reduce feeling "confused" or numb, and decrease the feelings of anger, stress and being overwhelmed. |
| Measure | Description | Time Frame |
|---|---|---|
| Toronto Alexithymia Scale-20 | his widely used alexithymia assessment (including the TBI population), is comprised of 3 factors: 1) ability to identify emotions); 2) ability to describe emotions; and 3) externally-oriented thinking. In addition to being a co-primary outcome measure, the TAS-20 scores will be used to determine eligibility (>.5 SD above published means). It is a CDE and a PhenX toolkit measure has good psychometric properties, including good test-retest reliability. Range: Min/ Max = 20 to 100 Lower scores indicate less alexithymia (good); higher scores indicate greater alexithymia (bad) | 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment. |
| Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome) | This commonly used measure of emotion dysregulation, uses a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.56 Will be used to evaluate emotion dysregulation and to determine eligibility (>.5 SD above published means). Range: Min/ Max = 36 to 180. Lower scores indicate less dysregulation (good); higher scores indicate more dysregulation (bad) | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| Measure | Description | Time Frame |
|---|---|---|
| Brief Resilience Scale (BRS) | Self-administered questionnaire with 6 items using a 5-point Likert-style scale to assess the ability to bounce back or recover from stress. Scores range from 6-30. The BRS is a recommended CDE in the PhenXToolkit and has been found to have good reliability and validity. Range: Min/ Max = 6 to 30. Lower scores indicate worse resilience; higher scores indicate better resilience |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Grace Wells | Contact | 732-321-7000 | 68682 | grace.wells1@hmhn.org |
| Amanda Melton | Contact | 317-408-5589 | amamelto@iu.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dawn Neumann, PhD, FACRM | Hackensack Meridian Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Indiana University | Recruiting | Indianapolis | Indiana | 46202 | United States |
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| Program 2 | Behavioral | Program 2 will teach participants strategies to improve their overall brain health and functioning. It will also teach participants how to develop and work towards individualized short-term and long-term goals aimed at improving their quality of life. |
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| 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| Patient Health Questionnaire-9 (PHQ-9; depression) | This 9 item self-report depression assessment uses a 3-point Likert scale with established validity and reliability, including in the TBI population.64,65 Participants rate the frequency of specified problems during the past 2 weeks. Range: Min/ Max = 0 to 27 Lower scores indicate less depression; higher scores indicate higher depression | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| PROMIS item banks for Anxiety | The PROMIS item bank (8a) for anxiety is 8 items and the Anger item bank (5a) includes 5 items. The Anxiety instrument measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). All use a 5-point Likert scale, ranging from never to always. These are Common Data Elements (CDE) measures and have good psychometric properties. Range: Min/ Max = 8 to 40 Lower scores indicate less anxiety; higher scores indicate higher anxiety | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| PROMIS item banks Anger | The PROMIS Anger instrument assesses self-reported angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. All use a 5-point Likert scale, ranging from never to always. These are Common Data Elements (CDE) measures and have good psychometric properties. Range: Min/ Max = 5 to 25 Lower scores indicate less anger; high scores indicate more anger | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| Post-traumatic Stress Checklist- 5 (PCL-5) | PCL-5 is used to measure PTSD symptomatology. The PCL-5 is a 20-item, self-rating scale that provides a quick and accurate measure of PTSD symptoms. Each item corresponds to current diagnostic criteria of PTSD, and each symptom is rated in terms of frequency and severity. The PCL-5 is applied generally to any traumatic event and therefore would capture any military-specific trauma. Psychometric properties indicate the PCL to be a valid instrument of PTSD symptoms. Range: Min/ Max = 0 to 80. Lower scores indicate less posttraumatic stress; high scores indicates greater post-traumatic stress | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| Patient Global Impression of Change (PGIC) emotional functioning and quality of life | The PGIC captures the patient perspective regarding the achievement of clinically important change with a single item asking perception of change across a rating scale ranging from 1 (no change) to 7 (a great deal better and a considerable improvement). Two separate PGIC assessments will be administered to participants immediately (within a week)- one to evaluate perceived change in global emotional functioning/ PH (PGIC-Emotion) and the other to evaluate perceived global changes in quality of life (PGIC-QoL). In addition to the traditional 7-point rating scale, participants will also be asked to provide a list of changes (if any) in their emotional functioning and psychological health for the PGIC-emotion, and to list any changes in their life quality for the PGIC-QoL. This "Free listing" will have participants list all the items, concepts, or ideas that come to mind regarding their global changes. | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months |
| National Intrepid Center Of Excellence | Not yet recruiting | Bethesda | Maryland | 20889 | United States |
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| Hackensack Meridian Health - JFK Johnson Rehabilitation Institute | Recruiting | Edison | New Jersey | 08820 | United States |
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| ID | Term |
|---|---|
| D001924 | Brain Concussion |
| D000342 | Affective Symptoms |
| ID | Term |
|---|---|
| D000070642 | Brain Injuries, Traumatic |
| D001930 | Brain Injuries |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
| D009422 | Nervous System Diseases |
| D006259 | Craniocerebral Trauma |
| D020196 | Trauma, Nervous System |
| D016489 | Head Injuries, Closed |
| D014947 | Wounds and Injuries |
| D014949 | Wounds, Nonpenetrating |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
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