An interventional study of TREAT in Traumatic Brain Injury and Alexithymia, sponsored by Indiana University. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-20.
Sponsored by Indiana University · Not applicable, Interventional, and Treatment
Among 12 studies in Brain Injuries, Traumatic by Indiana University — 2 open to participants now, 3 under way, none of them phase 3. Brain Injuries, Traumatic · Indiana University.
Among the 12 studies in Brain Injuries, Traumatic by Indiana University, this one is the 5th largest by enrollment, is one of 4 that started in 2018, is one of 11 with no phase, and was the 6th registered.
1,721 studies on the registry are indexed under Brain Injuries, Traumatic; 447 are open to participants now.
This study's enrollment of 44 is below the median of 52 across 1,088 interventional studies indexed under Brain Injuries, Traumatic.
Browse Brain Injuries, Traumatic studies →2 of the 12 studies in Brain Injuries, Traumatic by Indiana University are open now, in 1 country. Each count lists the studies.
Of the 281 Brain Injuries, Traumatic studies recruiting now, 120 (43%) set no upper age limit and 119 (42%) stop at 75 or younger; 40 take children under 18; 52 take healthy volunteers.
This study: 18 Years and older · all sexes · no healthy volunteers.
The full table on the hub →12 studies; the count open now beside each. This study's row is marked.
First in 2010; this study’s year is marked. 4 started in 2018.
Median enrollment 29 across the 12 interventional studies. Of the 8 that completed or were terminated, 3 (38%) have results posted.
Indiana University is the lead sponsor of 986 studies on the registry; 198 are open to participants now.
Of its 148 completed or terminated interventional studies of FDA-regulated products, 118 (80%) have results posted.
2 of the studies in Brain Injuries, Traumatic by Indiana University that are under way reach primary completion within a year, 0 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT05636020Indiana UniversityIntervention to Change Affect Recognition and Empathy | 2027-02 |
| NCT07038889Indiana UniversityOverground Virtual Reality (VR) Gait Rehabilitation for Traumatic Brain Injury (TBI) | 2027-06 |
Among the 12 studies in Brain Injuries, Traumatic by Indiana University, from their registry updates:
To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.
Phase II randomized, Waitlist Control (WLC) trial with 3-month follow-up to further establish proof of concept and early efficacy of TREAT (1:1 alexithymia treatment) for post-TBI alexithymia. It is anticipated that our target sample size is 44. The purpose of this study is to examine differences in post-treatment self-reported alexithymia and emotional self-awareness in participants with TBI randomized to TREAT or WLC. In addition to examining the differences in post-treatment self-reported emotion regulation (general), anxiety, anger, depression, positive affect (PA), global emotional function and quality of life in participants with TBI randomized to TREAT or WLC.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.
Behavioral: TREAT
After Time 1 testing in Week 1, participants randomized to WLC will not receive any treatment during Weeks 2-5. The only staff interaction during this no treatment time period will be to schedule Time 2 testing appointment for week 6. After Time 2 testing, WLC will receive TREAT (weeks 14-17), followed up with testing.
Behavioral: TREAT
A 4-week one-to-one intervention between the clinical RA (cRA) and participant. Comprised of eight sessions, it involves psycho-educational lessons and skill-building exercises to achieve objectives based on the characteristics of alexithymia.
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.
Time frame: Baseline Week , 6, 18, 30
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.
Time frame: Baseline Week , 6, 18, 30
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.
Time frame: Baseline Week , 6, 18, 30
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).
Time frame: Baseline Week , 6, 18, 30
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.
Time frame: Baseline Week , 6, 18, 30
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).
Time frame: Baseline Week , 6, 18, 30
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
Time frame: Baseline Week , 6, 18, 30
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
Time frame: Week 6 or 18 depending on randomization
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
Time frame: Week 6, 18, 30
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
Time frame: Week 6 or 18 depending on randomization
Ran from May 2018 to primary completion in Nov 2023, 66 months.
Of 442 non-industry interventional studies with no phase under Brain Injuries, Traumatic, half reached primary completion within 41 months of starting (the median), counting those still running; a quarter within 23 and three quarters within 64. This study's 66 months is above that.
Counting every sponsor, half of 464 studies reached it within 40 months; a quarter within 22 and three quarters within 64.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2024. You cannot join it, but the record below documents what was studied.
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