Alexithymia, Mild Traumatic Brain Injury
Conditions
Keywords
Emotional dysregulation, Brain training, Concussion, Veterans, Military service members
Brief summary
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.
Interventions
BEHAVIORALProgram 1
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.
BEHAVIORALProgram 2
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.
Sponsors
Hackensack Meridian Health
United States Department of Defense
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Mild TBI * ≥18 years old * ≥6 months post-TBI * Elevated alexithymia and emotion dysregulation * Capacity to consent * Speaks and understands English * Personal device capable of video conferencing and internet
Exclusion criteria
* Premorbid neurological disorder other than TBI * Degenerative neurologic condition * Active or uncontrolled major psychiatric disorder * Conditions that pose safety concern to self or others, such as suicide risk * Previous psychiatric hospitalization * Visual, hearing, communication, or cognitive impairments that would impede participation * Unstable medications (e.g., started \< 6 weeks prior to enrollment) or anticipated medication changes that will influence mood/ affect during study participation * Active involvement in an intensive rehabilitation program * Individuals who recently started psychotherapy and/or mental health counseling (e.g., \<3 months prior)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Toronto Alexithymia Scale-20 | 1) baseline 2) immediate post-treatment, 3) 3 months post-treatment; 4) 6- months post-treatment. | 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) |
| Difficulty with Emotion Regulation Scale (DERS; Co-Primary outcome) | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Brief Resilience Scale (BRS) | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | 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 |
| Patient Health Questionnaire-9 (PHQ-9; depression) | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | 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 |
| PROMIS item banks for Anxiety | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | 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 |
| PROMIS item banks Anger | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | 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 |
| Post-traumatic Stress Checklist- 5 (PCL-5) | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | 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 |
| Patient Global Impression of Change (PGIC) emotional functioning and quality of life | 1) baseline 2) immediate post-treatment, 3) 3 months; 4) 6- months | 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. |
Countries
United States
Contacts
CONTACTGrace Wells
CONTACTAmanda Melton
PRINCIPAL_INVESTIGATORDawn Neumann, PhD, FACRM
Hackensack Meridian Health
Outcome results
None listed