Training to Reconnect With Emotional Awareness Therapy (TREAT)

Indiana University

Status: Completed

Conditions: Alexithymia; Traumatic Brain Injury

Treatments: Behavioral: TREAT

Study type: Interventional

Funder types: Other

Identifiers

NCT03414463

1711946589

Details and patient eligibility

About

To decrease emotional self-awareness deficits and improve emotional self-regulation, particularly anxiety, anger, depression, and positive affect, through the treatment of alexithymia.

Full 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.

Enrollment: 44 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 2 patient groups

TREAT

Experimental group

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.

Treatment:

Behavioral: TREAT

Waitlist Control

Experimental group

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.

Treatment:

Behavioral: TREAT