Back to resultsTraining to Reconnect With Emotional Awareness Therapy (TREAT)
Primary Purpose
Traumatic Brain Injury, Alexithymia
Status
Active
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
TREAT
Sponsored by
About this trial
This is an interventional treatment trial for Traumatic Brain Injury focused on measuring Brain Injury
Eligibility Criteria
Inclusion Criteria:
- 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
- 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
Exclusion Criteria:
- 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
Sites / Locations
- Rehabilitation Hospital of Indiana
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
TREAT
Waitlist Control
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
State-Trait Anxiety Inventory (STAI):
The STAI is a self-report measure of state and trait anxiety (20 items each). Higher scores indicate more anxiety. For the purposes of this study, we will only be administering the "trait" subscale of the STAI. The STAI has concurrent validity with other anxiety measures and has been used in TBI research.
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.
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).
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03414463
Brief Title
Training to Reconnect With Emotional Awareness Therapy
Acronym
TREAT
Official Title
Training to Reconnect With Emotional Awareness Therapy
Study Type
Interventional
2. Study Status
Record Verification Date
June 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
May 8, 2018 (Actual)
Primary Completion Date
December 30, 2023 (Anticipated)
Study Completion Date
December 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Indiana University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Traumatic Brain Injury, Alexithymia
Keywords
Brain Injury
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
44 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TREAT
Arm Type
Experimental
Arm Description
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.
Arm Title
Waitlist Control
Arm Type
Experimental
Arm Description
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.
Intervention Type
Behavioral
Intervention Name(s)
TREAT
Intervention Description
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.
Primary Outcome Measure Information:
Title
Change in Toronto Alexithymia Scale-20 (TAS-20)
Description
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
Title
Change in Levels of Emotional Awareness Scale (LEAS)
Description
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
Secondary Outcome Measure Information:
Title
Difficulty with Emotion Regulation Scale (DERS)
Description
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
Title
State-Trait Anxiety Inventory (STAI):
Description
The STAI is a self-report measure of state and trait anxiety (20 items each). Higher scores indicate more anxiety. For the purposes of this study, we will only be administering the "trait" subscale of the STAI. The STAI has concurrent validity with other anxiety measures and has been used in TBI research.
Time Frame
Baseline Week , 6, 18, 30
Title
Patient Health Questionnaire 9 (PHQ-9)
Description
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
Title
State-Trait Anger Expression Inventory (STAXI)
Description
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
Title
Positive and Negative Affect Scale (PANAS)
Description
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
Title
Patient Global Impression of Change (PGIC)
Description
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 6,18, 30
Title
Caregiver Global Impression of Change (CaGIC)
Description
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
Title
Participant Satisfaction
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
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
Exclusion Criteria:
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Dawn Neumann, PhD
Organizational Affiliation
Indiana University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Rehabilitation Hospital of Indiana
City
Indianapolis
State/Province
Indiana
ZIP/Postal Code
46254
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Training to Reconnect With Emotional Awareness Therapy
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