Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu

Training to Reconnect With Emotional Awareness Therapy (TREAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03414463
Recruitment Status : Recruiting
First Posted : January 30, 2018
Last Update Posted : May 14, 2018
Sponsor:
Information provided by (Responsible Party):
Dawn Neumann, Indiana University

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.

Condition or disease Intervention/treatment Phase
Traumatic Brain Injury Alexithymia Behavioral: TREAT Not Applicable

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.

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Training to Reconnect With Emotional Awareness Therapy
Actual Study Start Date : May 8, 2018
Estimated Primary Completion Date : December 31, 2021
Estimated Study Completion Date : December 31, 2022

Arm Intervention/treatment
Experimental: 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.
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.

Experimental: Waitlist Control
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.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. Difficulty with Emotion Regulation Scale (DERS) [ Time Frame: Baseline Week , 6, 18, 30 ]
    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.

  2. State-Trait Anxiety Inventory (STAI): [ Time Frame: Baseline Week , 6, 18, 30 ]
    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.

  3. Patient Health Questionnaire 9 (PHQ-9) [ Time Frame: Baseline Week , 6, 18, 30 ]
    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.

  4. State-Trait Anger Expression Inventory (STAXI) [ Time Frame: Baseline Week , 6, 18, 30 ]
    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).

  5. Positive and Negative Affect Scale (PANAS) [ Time Frame: Baseline Week , 6, 18, 30 ]
    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

  6. Patient Global Impression of Change (PGIC) [ Time Frame: Week 6,18, 30 ]
    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

  7. Caregiver Global Impression of Change (CaGIC) [ Time Frame: Week 6,18, 30 ]
    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

  8. Participant Satisfaction [ Time Frame: Week 6 ]
    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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  • have moderate to high screening alexithymia score (TAS-20 ≥52).

Exclusion Criteria:

  • diagnosed with pre-morbid neurological disorder (e.g., stroke, autism, developmental delay)
  • diagnosed with major psychiatric disorder (e.g., schizophrenia)
  • diagnosed with a degenerative neurologic condition
  • unable to follow directions; visual or hearing impairments that would impede participation
  • unable to communicate verbally
  • unstable or anticipated medication changes during study participation
  • active psychological treatment; or actively participating in the Traumatic Brain Injury Model System (TBIMS) alexithymia outcome module

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03414463


Contacts
Layout table for location contacts
Contact: Ryan Mayfield, BS 317-329-2380 interfac@iu.edu
Contact: Kelsey Hurm, MA 317-329-2044 interfac@iu.edu

Locations
Layout table for location information
United States, Indiana
Rehabilitation Hospital of Indiana Recruiting
Indianapolis, Indiana, United States, 46254
Contact: Krista Smith, BS    317-329-2035    smithkrd@iupui.edu   
Sponsors and Collaborators
Indiana University
Investigators
Layout table for investigator information
Principal Investigator: Dawn Neumann, PhD Indiana Universtiy

Layout table for additonal information
Responsible Party: Dawn Neumann, Research Director of Physical Medicine and Rehabilitation, Indiana University
ClinicalTrials.gov Identifier: NCT03414463     History of Changes
Other Study ID Numbers: 1711946589
First Posted: January 30, 2018    Key Record Dates
Last Update Posted: May 14, 2018
Last Verified: May 2018

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Dawn Neumann, Indiana University:
Brain Injury

Additional relevant MeSH terms:
Layout table for MeSH terms
Brain Injuries
Brain Injuries, Traumatic
Affective Symptoms
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Wounds and Injuries
Behavioral Symptoms