NCT03414463

Training to Reconnect With Emotional Awareness Therapy

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 44 (actual)
• Sponsor: Indiana University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Traumatic Brain Injury
• Alexithymia

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2018-05-08
• Primary completion: 2023-11-10
• Completion: 2023-11-14
• First posted: 2018-01-30
• Last updated: 2024-05-20

Locations

1 site across 1 country: United States