Traumatic Brain InjuryTREATNCT03414463
Training to Reconnect With Emotional Awareness Therapy
A study testing TREAT in people with Traumatic Brain Injury and Alexithymia, run by Indiana University at 1 site in United States.
Trial summary
To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Traumatic Brain Injury, Alexithymia
- What is being tested?
- TREAT
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 1 siteUnited States
- Study dates
- 8 May 2018to 14 Nov 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- TBI (injury due to a external physical force)
- Complicated mild, moderate, or severe TBI (defined by Glasgow Coma Scale (GCS) in Emergency Department (ED) (≤12), or Post traumatic amnesia (PTA) (≥1 day),Loss of Conscientious (LOC) (≥30 minutes),or positive head CT scan consistent with TBI)
- At least 18 years or older
- ≥1 year post-injury
- Adequate vision, hearing, speech, and comprehension
- Reliable mode of transportation
Show all 9Show fewer
- Available for treatment during regular business hours
- Have moderate to high screening alexithymia score (TAS-20 ≥52)
- If participating in active psychological treatment prior to enrollment, their participation must be ongoing for 4 or more weeks
Who cannot join
- Diagnosed with pre-morbid neurological disorder that could affect mood and cognition (e.g., stroke, Alzheimer's disease, Parkinson's disease); does not include controlled seizures
- Diagnosed with major psychiatric disorder (e.g., schizophrenia, Borderline Personality Disorder)
- Severe Depression and/or perceived risk to self or others
- Developmental disability (e.g. autism, developmental delay)
- Unstable or anticipated medication changes related to mood or emotion during study participation
- Having started psychological treatment less than 4 weeks prior to enrollment
- Actively participating in the Traumatic Brain Injury Model System (TBIMS) alexithymia outcome module
Trial locations and contacts
1 site in 1 country.
United States1 site
Rehabilitation Hospital of Indiana
Indianapolis, Indiana, 46254
About this study
To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.
Read the detailed description
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.
- Conditions
- Traumatic Brain Injury, Alexithymia
- Being tested
- TREAT
- Keywords
- Brain Injury
- Medical subject headings
- Brain Injuries, Traumatic, Affective Symptoms, Brain Injuries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TREATBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| TREAT | Experimental | 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. Receives: Behavioral: TREAT |
| Waitlist Control | Experimental | 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. Receives: Behavioral: TREAT |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline Week , 6, 18, 30
Secondary outcomes (8)
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.
Measured: 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).
Measured: 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.
Measured: 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).
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: Week 6 or 18 depending on randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2018
- Study start8 May 2018
- Primary completion10 Nov 2023
- Study completion14 Nov 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Traumatic Brain InjuryStudies of the same condition, open and under way.
- More trials run by Indiana UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Indiana University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Flora Hammond, Indiana University
- Investigators
- Flora Hammond, MD, Principal investigator, Indiana University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03414463
- Sponsor's protocol ID
- 1711946589
- Acronym
- TREAT
- Status last verified
- May 2024
- First submitted
- 11 Jan 2018
- Last updated
- 20 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Training to Reconnect With Emotional Awareness Therapy
- ClinicalTrials.gov ID
- NCT03414463
- Acronym / sponsor ID
- TREAT / 1711946589
- Conditions
- Traumatic Brain Injury, Alexithymia
- Keywords
- Brain Injury
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Indiana UniversityUniversity, hospital or other
- Study start
- 8 May 2018 (actual)
- Primary completion
- 10 Nov 2023 (actual)
- Study completion
- 14 Nov 2023 (actual)
- First posted
- 30 Jan 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| TREAT | Experimental | Behavioral: TREATA 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. |
| Waitlist Control | Experimental | Behavioral: TREATAfter 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- TBI (injury due to a external physical force)
- Complicated mild, moderate, or severe TBI (defined by Glasgow Coma Scale (GCS) in Emergency Department (ED) (≤12), or Post traumatic amnesia (PTA) (≥1 day),Loss of Conscientious (LOC) (≥30 minutes),or positive head CT scan consistent with TBI)
- At least 18 years or older
- ≥1 year post-injury
- Adequate vision, hearing, speech, and comprehension
Key exclusion criteria (7 listed)
- Diagnosed with pre-morbid neurological disorder that could affect mood and cognition (e.g., stroke, Alzheimer's disease, Parkinson's disease); does not include controlled seizures
- Diagnosed with major psychiatric disorder (e.g., schizophrenia, Borderline Personality Disorder)
- Severe Depression and/or perceived risk to self or others
- Developmental disability (e.g. autism, developmental delay)
- Unstable or anticipated medication changes related to mood or emotion during study participation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TREATA 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. | Behavioural | TREAT, Waitlist Control |
Primary outcome
Change in Toronto Alexithymia Scale-20 (TAS-20)
Time frame: Baseline Week , 6, 18, 30
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.
Change in Levels of Emotional Awareness Scale (LEAS)
Time frame: Baseline Week , 6, 18, 30
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.
8 secondary outcomes
Difficulty with Emotion Regulation Scale (DERS)
Time frame: Baseline Week , 6, 18, 30
Generalized Anxiety Disorder Assessment (GAD-7):
Time frame: Baseline Week , 6, 18, 30
Patient Health Questionnaire 9 (PHQ-9)
Time frame: Baseline Week , 6, 18, 30
State-Trait Anger Expression Inventory (STAXI)
Time frame: Baseline Week , 6, 18, 30
Positive and Negative Affect Scale (PANAS)
Time frame: Baseline Week , 6, 18, 30
Patient Global Impression of Change (PGIC)
Time frame: Week 6 or 18 depending on randomization
Caregiver Global Impression of Change (CaGIC)
Time frame: Week 6, 18, 30
Participant Satisfaction
Time frame: Week 6 or 18 depending on randomization
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Flora Hammond, MD principal investigator
Indiana University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TREAT in people with Traumatic Brain Injury and Alexithymia, run by Indiana University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Toronto Alexithymia Scale-20 (TAS-20) (time frame: Baseline Week , 6, 18, 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2024.