Training to Reconnect With Emotional Awareness Therapy

NCT03414463 | Completed

• 1 other identifier: 1711946589
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

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.

Conditions

Traumatic Brain Injury; Alexithymia

Keywords

Brain Injury

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  Baseline Week , 6, 18, 30

Secondary Outcomes (8)

• Difficulty with Emotion Regulation Scale (DERS)

  Baseline Week , 6, 18, 30

• Generalized Anxiety Disorder Assessment (GAD-7):

  Baseline Week , 6, 18, 30

• Patient Health Questionnaire 9 (PHQ-9)

  Baseline Week , 6, 18, 30

• State-Trait Anger Expression Inventory (STAXI)

  Baseline Week , 6, 18, 30

• Positive and Negative Affect Scale (PANAS)

  Baseline Week , 6, 18, 30

Study Arms (2)

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.

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.

Behavioral: TREAT

Interventions

TREAT BEHAVIORAL

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.

TREAT; Waitlist Control

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Indiana University: lead

Study Sites (1)

Rehabilitation Hospital of Indiana

Indianapolis, Indiana, 46254, United States

Location

MeSH Terms

Conditions

Brain Injuries, Traumatic; Affective Symptoms; Brain Injuries

Condition Hierarchy (Ancestors)

Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Craniocerebral Trauma; Trauma, Nervous System; Wounds and Injuries; Behavioral Symptoms; Behavior

Study Officials

• Flora Hammond, MD

  Indiana University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair of Department of Physical Medicine and Rehabilitation

Study Record Dates

• First Submitted: January 11, 2018
• First Posted: January 30, 2018
• Study Start: May 8, 2018
• Primary Completion: November 10, 2023
• Study Completion: November 14, 2023
• Last Updated: May 20, 2024

Record last verified: 2024-05

Locations

US (1)