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Building Emotional Self-Awareness Teletherapy (BEST) (BEST)

Primary Purpose

Concussion, Mild, Concussion, Brain, Concussion, Severe

Status

Recruiting

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Treatment

About this trial

This is an interventional treatment trial for Concussion, Mild focused on measuring Alexithymia, Brain Injury, Concussion, Emotion Dysregulation, Affect, Resilience, Military, Service Members, Mood, Teletherapy

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Mild TBI (determined by Ohio State University TBI Identification Method) ≥18 years old U.S. resident (exclusion for California residents) ≥6 months post-TBI elevated alexithymia and emotion dysregulation (defined by >.5 standard deviation above means on the TAS-20 and DERS) capacity to consent proficient English if on medications that influence affect, must be stable for at least 6 weeks access to a device capable of video conferencing and high speed internet. Exclusion Criteria: Premorbid neurological disorder other than TBI (e.g., stroke), active or uncontrolled major psychiatric disorder and/ or disorder that would pose a safety concern (e.g., borderline personality disorder) degenerative neurologic condition visual, hearing, communication, or cognitive impairments that would impede participation unstable or anticipated medication changes that will influence mood/ affect during study participation active involvement in an intensive rehabilitation program individuals who recently started psychotherapy (e.g., < 3 months ago) concurrent participation in any other clinical trial that aims to improve mood/ behavioral functioning will be an exclusion criterion. participants will be excluded if at any point, they participated in TREAT (in-person clinical trial of BEST - NCT03414463)

Sites / Locations

Indiana UniversityRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment

Arm Description

8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes.

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 (worse) alexithymia). Subscales are summed to compute a total score.

Secondary Outcome Measures

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. More discrete emotions earn more points (e.g., "sad" scores better than "bad"). 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.

Change in 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. Scores range from 5 (low) to 180 (high). Higher scores are indicative of more emotion dysregulation problems. The DERS has high internal consistency, test-retest reliability, and good construct validity.

Full Information

NCT ID

NCT05623046

First Posted

November 14, 2022

Last Updated

August 31, 2023

Sponsor

Indiana University

Collaborators

National Intrepid Center of Excellence, Congressionally Directed Medical Research Programs

1. Study Identification

Unique Protocol Identification Number

NCT05623046

Brief Title

Building Emotional Self-Awareness Teletherapy (BEST)

Acronym

BEST

Official Title

Building Emotional Self-Awareness Teletherapy (BEST): A Tool to Optimize Psychological Health Outcomes for Persons With Traumatic Brain Injury

Study Type

Interventional

2. Study Status

Record Verification Date

August 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 23, 2023 (Actual)

Primary Completion Date

July 2025 (Anticipated)

Study Completion Date

July 2025 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Indiana University

Collaborators

National Intrepid Center of Excellence, Congressionally Directed Medical Research Programs

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

To examine the feasibility, acceptability, and preliminary efficacy of a remotely delivered intervention for civilians and service members with mild traumatic brain injury (mTBI) who have difficulty recognizing and regulating their emotions. Post-treatment outcomes of interest include emotional self-awareness and regulation, resiliency, and affective symptoms.

Detailed Description

This Phase I proof of principle pilot study of the Building Emotional Self-awareness Teletherapy (BEST) intervention will use a quasi-experimental, non-randomized, one-group pretest-posttest design with a double pretest and a 3-month follow-up in approximately 40 participants with mTBI (~20 civilians and ~20 service members). Study objectives are to explore the feasibility and early efficacy of BEST to improve psychological health outcomes in civilian and Service Member (SM) participants with mTBI who have alexithymia (poor emotional self-awareness) and emotion dysregulation. We anticipate BEST will have good feasibility and acceptability in both civilian and service member participants, and post-treatment assessments will show significant improvements in alexithymia, emotion regulation, resiliency, and affective symptoms.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Concussion, Mild, Concussion, Brain, Concussion, Severe, Concussion, Intermediate, Concussion; Syndrome, Concussion Injury of Cerebrum, Concussion With Brief Loss of Consciousness, Alexithymia

Keywords

Alexithymia, Brain Injury, Concussion, Emotion Dysregulation, Affect, Resilience, Military, Service Members, Mood, Teletherapy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Treatment

Arm Type

Experimental

Arm Description

8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes.

Intervention Type

Behavioral

Intervention Name(s)

Treatment

Intervention Description

8 one-on-one teletherapy training sessions to enhance emotional skills. Teletherapy sessions will last approximately 60-90 minutes

Primary Outcome Measure Information:

Title

Change in Toronto Alexithymia Scale-20 (TAS-20)

Description

Time Frame

Baseline, Week 6, Week 12, Week 24

Secondary Outcome Measure Information:

Title

Change in Levels of Emotional Awareness Scale (LEAS)

Description

Time Frame

Baseline, Week 6, Week 12, Week 24

Title

Change in Difficulty with Emotion Regulation Scale (DERS)

Description

Time Frame

Baseline, Week 6, Week 12, Week 24

Other Pre-specified Outcome Measures:

Title

Change in Brief Resilience Scale (BRS)

Description

The BRS is a self-administered questionnaire with 6 items using a 5-point Likert-style scale to assess the ability to bounce back or recover from stress. Scores range from 6-30. Higher scores are indicative of greater resilience. Total score is determined by calculating the average across all 6 responses. Scores can then be classified as Low, Normal, or High Resilience.

Time Frame

Baseline, Week 6, Week 12, Week 24

Title

Change in Positive and Negative Affect Schedule (PANAS)

Description

The PANAS is a 20-item subjective assessment of mood (10 items for Positive Affect [PA] and 10 for Negative Affect [NA]). Using a 5-point scale, participants rate the extent to which they have experienced each mood state during a specified time frame. Subscale scores for positive and negative affect are calculated with scores ranging from 10-50. For the Positive subscale, higher score equal more positive affect. For the negative affect subscale, higher scores are indicative of more negative affect.

Time Frame

Baseline, Week 6, Week 12, Week 24

Title

Change in Patient Health Questionnaire-9 (PHQ-9)

Description

This self-report depression assessment uses a 3-point Likert scale (score range 0-27) with higher scores indicating greater depression severity. Participants rate the frequency of specified problems during the past 2 weeks.

Time Frame

Baseline, Week 6, Week 12, Week 24

Title

Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anxiety

Description

The PROMIS Anxiety item bank (8a) is 8 items. The instrument measures self-reported fear (fearfulness, panic), anxious misery (worry, dread), hyperarousal (tension, nervousness, restlessness), and somatic symptoms related to arousal (racing heart, dizziness). It uses a 5-point Likert scale, ranging from never to always. Anxiety scores range from 5-40 with higher scores indicating greater severity of anxiety.

Time Frame

Baseline, Week 6, Week 12, Week 24

Title

Change in Patient Reported Outcomes Measurement Information System (PROMIS) Anger

Description

The PROMIS Anger item bank (5a) includes 5 items. The Anger instrument assesses self-reported angry mood (irritability, frustration), negative social cognitions (interpersonal sensitivity, envy, disagreeableness), and efforts to control anger. It uses a 5-point Likert scale, ranging from never to always. Anger scores range from 5-25 with higher scores indicating greater severity of anger.

Time Frame

Baseline, Week 6, Week 12, Week 24

Title

Change in Post-traumatic Stress Checklist- 5 (PCL-5)

Description

The PCL-5 is a 20-item, self-rating scale that provides a quick and accurate measure of PTSD symptoms. Each item corresponds to current diagnostic criteria of PTSD, and each symptom is rated in terms of frequency and severity. Scores range from 0-80 with higher scores indicating greater symptom severity.

Time Frame

Baseline, Week 6, Week 12, Week 24

Title

Patient Global Impression of Change (PGIC)

Description

The PGIC captures the patient perspective regarding the achievement of clinically important change with a single item asking perception of change across a Likert scale ranging from 1 (no change) to 7 (a great deal better and a considerable improvement).

Time Frame

Week 12 and Week 24

Title

Post-treatment Satisfaction Survey

Description

Overall satisfaction and satisfaction with remote delivery will be evaluated with a 9-point scale. Participants will respond to the following statements: 1) Overall, how satisfied were you with BEST? (Overall treatment satisfaction); and 2) How satisfied were you with receiving this type of treatment remotely/ via teletherapy? (Teletherapy satisfaction). Scores on each scale range from 1-9. Lower scores indicate lower satisfaction. Higher scores indicate higher satisfaction.

Time Frame

Week 12

Title

Change in Neurobehavioral Symptom Inventory (NSI)

Description

The NSI is a validated 22-item self-report measure that assesses the degree of disturbance in 3 neurobehavioral symptom domains in the past 2 weeks: somatic/ sensory (e.g. dizziness, balance, nausea, vision), affective (e.g., anxiety, depression, irritability, fatigue, sleep) and cognitive (e.g., concentration, forgetfulness, decision-making, slowed thinking). On this measure, respondents rate the degree of symptom severity on a five-point scale that ranges from zero (none; symptom is rarely ever present/not a problem at all) to four (very severe; symptom is almost always present/impairs performance at work, school, or home/individual probably cannot function without help). Scores range from 0 to 110, with higher scores indicative of more severe neurobehavioral symptoms.

Time Frame

Baseline, Week 12, Week 24

Title

Change in Phenotypes and exposures (PhenX) Mental Health Core Items: Alcohol Use and Substance Use

Description

Participants will be asked their use, over the last 30 days, of alcohol (quantity and frequency) and substances (frequency).

Time Frame

Baseline, Week 12, Week 24

Title

Change in Alcohol Use Disorders Identification Test (AUDIT-C)

Description

The AUDIT-C is a 10-item validated self-report tool developed by the World Health Organization to assess alcohol consumption, drinking behaviors, and alcohol-related problems. Scores range from 0-12 with higher scores indicating greater alcohol use and problems.

Time Frame

Baseline, Week 12, Week 24

Title

Change in Drug Abuse Screen Test (DAST-10)

Description

This is a 10-item self-report questionnaire that provides an index of drug abuse problems. Scores range from 0-10 with higher scores indicating more drug abuse.

Time Frame

Baseline, Week 12, Week 24

Title

Change in Pain Catastrophizing Scale

Description

This 13-item scale evaluates the thoughts and feelings people have related to their pain. Participants rate the degree to which they agree with statements describing thoughts/ feelings about their pain (e.g., I worry all the time about whether the pain will end) on a scale ranging from 0 (not at all) to 4 (all the time). The total scores range from 0-52, with higher scores indicating more severe pain catastrophizing.

Time Frame

Baseline, Week 12, Week 24

Title

Change in PROMIS Pain Intensity Short Form (3a)

Description

This is a 3 item self-assessment of worst pain and average pain intensity in the last 7 days as well as current pain. Scores range from 3-15 with higher scores indicating greater pain severity.

Time Frame

Baseline, Week 12, Week 24

Title

Change in PROMIS Pain Interference (8a short form)

Description

This is an eight item measure of self-reported consequences of pain on relevant aspects of a person's life and may include the extent to which pain hinders engagement with social, cognitive, emotional, physical, and recreational activities. Scores range from 6-30 with higher scores indicating more pain interference.

Time Frame

Baseline, Week 12, Week 24

Title

Change in Perth Alexithymia Questionnaire (PAQ)

Description

This questionnaire asks about how participants perceive and experience unpleasant and pleasant emotions. Participants will be presented with statements and must indicate on a 7-point scale, how much they agree or disagree that the statement is true in describing themselves. Scores range from 24-168 with five subscale scores and a total score indicating level of alexithymia.

Time Frame

Baseline, Week 12, Week 24

Title

Change in Ambivalence over Emotional Expressiveness Questionnaire (AEQ)

Description

This is a 14-item self-report of the degree to which one feels ambivalent about expressing emotions using a 5-point Likert scale, with higher scores indicating greater ambivalence in expression. Total scores range from 14-70.

Time Frame

Baseline, Week 12, Week 24

Title

Change in Emotional Approach Coping (EAC)

Description

The 8-item emotional approach coping scale assesses participants' understanding and processing of emotions in general. The EAC has good internal consistency and validity. Items are rated from 1 (I usually don't do this at all) to 4 (I usually do this a lot) and averaged. Total scores range from 8- 32. Higher mean scores indicate more use of emotional approach as a coping style.

Time Frame

Baseline, Week 12, Week 24

Title

Change in UPPS-P (Negative Urgency subscale only)

Description

This measure evaluates various domains of impulsive behavior. One of these domain subscales is negative urgency, which is the only subscale that will be administered as part of this protocol. For this 4-item subscale, participants are presented with statements for which they must rate their agreement, using a 4-point Likert scale. Scores range from 4-16. Higher scores indicate more negative urgency.

Time Frame

Baseline, Week 12, Week 24

Title

Change in Process Model of Emotion Regulation Questionnaire (PMERQ)

Description

This questionnaire evaluates engagement and disengagement strategies that people use to regulate their negative emotions at different stages of emotion regulation (situation selection, situation modification, attentional deployment, cognitive (re)appraisal, and response modulation). Participants rate the degree of their agreement with statements using a scale that ranges from -3 (Strongly Disagree) to 3 (Strongly Agree).

Time Frame

Baseline, Week 12, Week 24

Title

Change in Multidimensional Assessment of Interoceptive Awareness (MAIA)

Description

The MAIA comprises 37 items on eight scales, conceptually organized in five dimensions: (a) Awareness of body sensations (Noticing scale), (b) emotional reaction and attentional response to sensations (Not-Distracting and Not-Worrying scales), (c) capacity to regulate attention (Attention Regulation scale), (d) awareness of mind-body integration (Emotional Awareness, Self-Regulation, and Body Listening scales), and (e) trusting body sensations (Trusting scale). Total scores range from 0-185. Higher score indicate greater interoceptive awareness.

Time Frame

Baseline, Week 12, Week 24

Title

Change in NIH Toolbox Loneliness

Description

This 5 item measure of loneliness asks about the frequency with which participants felt different aspects of loneliness over the last month using a 5-point scale (1=Never to 5=Always). Total scores range from 5-25. Higher scores indicate more feelings of loneliness.

Time Frame

Baseline, Week 12, Week 24

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Amanda Melton

Phone

3173292380

amamelto@iu.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Rebecca Runkel

Phone

3173292380

interfac@iupui.edu

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

Indiana University

City

Indianapolis

State/Province

Indiana

ZIP/Postal Code

46202

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Amanda Melton

Phone

317-329-2380

amamelto@iu.edu

12. IPD Sharing Statement

Learn more about this trial

Building Emotional Self-Awareness Teletherapy (BEST)

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