Outcome
| Type |
Measure |
Description |
Time frame |
Safety issue |
| Primary |
Change in Toronto Alexithymia Scale-20 (TAS-20) |
This is a 20-item self report questionnaire comprised of three sub-constructs (Difficulty Identifying feelings, Difficulty Describing feelings, Externally-oriented Thinking). The full scale range is 20-100 (higher scores indicate higher alexithymia). Subscales are summed to compute a total score. Scores between 52 and 60 indicate moderate alexithymia; scores 61 and higher indicate high alexithymia. |
Baseline Week , 6, 18, 30 |
|
| Primary |
Change in Levels of Emotional Awareness Scale (LEAS) |
objective, performance-based measure of emotional awareness and labeling. Short hypothetical scenarios are presented and participants are asked to describe how they and others would feel in the context of the scenarios. Participants' responses are scored with an electronic system, removing human bias and interpretation. The LEAS has parallel forms (A and B), which will alternate at testing sessions. |
Baseline Week , 6, 18, 30 |
|
| Secondary |
Difficulty with Emotion Regulation Scale (DERS) |
Using a 5-point Likert scale, participants rate the frequency they utilize self-regulation behaviors in response to general emotional distress. There are 6 subscales: Lack of Emotional Awareness, Lack of Emotional Clarity, Difficulties Controlling Impulsive Behaviors When Distressed, Difficulties Engaging in Goal-Directed Behavior When Distressed, Non-acceptance of Negative Emotional Responses, and Limited Access to Effective Emotion Regulation Strategies. Items are summed to provide a Total Emotion Dysregulation score. The DERS has high internal consistency, test-retest reliability, and good construct validity.61 Importantly, because this measure assesses difficulties regulating all types of emotions, it captures different information than that provided by measures specific to anxiety, anger, or depression which can miss more general, yet common, self-regulation problems. |
Baseline Week , 6, 18, 30 |
|
| Secondary |
Generalized Anxiety Disorder Assessment (GAD-7): |
A self-report 7-item questionnaire (score range is 0 to 21) that assesses frequency of seven anxiety symptoms linked to the DSM-IV criteria for Generalized Anxiety Disorder (GAD). Higher scores indicate higher levels of anxiety severity (higher=worse). |
Baseline Week , 6, 18, 30 |
|
| Secondary |
Patient Health Questionnaire 9 (PHQ-9) |
This self-report depression assessment uses a 3-point Likert scale (maximum score 27), with established validity and reliability, including in the TBI population. Participants rate the frequency of specified problems during the past 2 weeks. |
Baseline Week , 6, 18, 30 |
|
| Secondary |
State-Trait Anger Expression Inventory (STAXI) |
consists of 57 questions that address the intensity and the frequency of internal and external expressions of anger rated on a 4-point Likert scale. The measure is comprised of 3 subscales, each with individual t-scores: "How I feel right now"; "How I generally feel"; "How I generally react or behave when angry or furious." For the purpose of this study, we will only be administering the latter 2 subscales ("How I generally feel" and "How I generally react or behave). |
Baseline Week , 6, 18, 30 |
|
| Secondary |
Positive and Negative Affect Scale (PANAS) |
20-item subjective assessment of mood (10 items for Positive Affect and 10 for Negative Affect). Participants rate on a 5-point scale the extent to which they have experienced each mood state during a specified time frame. This measure showed a significantly increased positive affect in Phase I. The measure has shown good test-retest reliability over a number of weeks and validity in a variety of populations |
Baseline Week , 6, 18, 30 |
|
| Secondary |
Patient Global Impression of Change (PGIC) |
This Likert scale, used in prior TBI studies captures the patient perspectives of clinically important change in participant global emotional function and quality of life during the course of study participation. Responses range from 1 (very much worse) to 7 (very much improved). Depending on participants' preferences |
Week 6 or 18 depending on randomization |
|
| Secondary |
Caregiver Global Impression of Change (CaGIC) |
This Likert scale, used in prior TBI studies captures the caregiver perspectives of clinically important change in participant global emotional function and quality of life during the course of study participation. Responses range from 1 (very much worse) to 7 (very much improved). Depending on participants' preferences |
Week 6, 18, 30 |
|
| Secondary |
Participant Satisfaction |
Using the same satisfaction questions from the Phase I preliminary study, participants will respond to the following statements using a 5-point Likert scale (1=Strongly Disagree to 5=Strongly Agree): 1) I am satisfied with the information taught in this training program; 2) The lessons taught in the training are relevant to my needs; 3) I will try to use the lessons I learned from this training in my daily life; 4) The information provided in this training program was easy to understand; 5) If a friend or family member was in need similar help, I would recommend the program to him or her; and 6) I think the training program helped me to deal more effectively with my emotions. The participant will be asked seventh open-ended questions regarding additional comments about the training program. Depending on participants' preferences |
Week 6 or 18 depending on randomization |
|
