Treating Emotional Processing Impairments in Individuals With TBI

Treating Emotional Processing Impairments in Individuals With TBI: A Randomized Controlled Trial

The current project will examine the impact of an emotional processing intervention on emotional processing abilities in a sample of 50 persons with moderate to severe TBI. Outcome will be assessed across 3 domains. We will document changes resulting from treatment: (1) in emotional processing tasks (2) in other areas of function including QOL, social functioning, mood and cognition that are also likely to be impacted (3) in brain structure and function. The examination of efficacy in the above three areas will further our knowledge of emotional processing deficits in TBI and more importantly, identify an effective means of treating such deficits.

Study Overview

• Status: Unknown
• Conditions: Traumatic Brain Injury
• Intervention / Treatment: Behavioral: Emotional Processing Training; Behavioral: Placebo Control Exercises

Detailed Description

Emotional processing deficits have a significant negative impact on the lives of persons with TBI. There is emerging research indicating that, in addition to cognitive and behavioral impairments, social and emotional difficulties following TBI are common and are related to significant problems in social relationships, poor social participation, impaired empathy, and a high degree of caregiver stress. Emotional processing is a critical component of social cognition, including the abilities to both identify and discriminate basic universal emotions. The stability of emotional processing deficits following TBI indicates that these impairments likely impact individuals with TBI consistently across the lifespan, and do not appear to resolve with time.

The goals of the trial are to (a) Evaluate the effectiveness of an emotional processing intervention to improve performance on tests of emotional processing in individuals with TBI, (b) Evaluate the improvement of secondary outcomes of psychological, cognitive, and functional abilities following the emotional processing intervention in individuals with TBI, (c) To examine differences in brain activation patterns during emotional processing following treatment in individuals with TBI, BOLD activation in the experimental group will be compared to BOLD patterns of the control group during performance of the QFDT, a facial affect recognition task.

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Angela Smiith, MA; Phone Number: 973-324-8448; Email: asmith@kesslerfoundation.org

Study Locations

• United States
  • New Jersey
    • East Hanover, New Jersey, United States, 07936
      • Recruiting
      • Kessler Foundation

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 65 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• diagnosis of Traumatic Brain Injury (TBI)
• can read and speak English fluently

Exclusion Criteria:

• prior stroke or neurological disease.
• history of significant psychiatric illness (for example, bipolar disorder, schizophrenia, or psychosis) or a current diagnosis of Major Depressive Disorder, Schizophrenia, Epilepsy, Bipolar Disorder
• significant alcohol or drug abuse history

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Experimental Group; Participants in the experimental group will receive emotional processing training exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).	Behavioral: Emotional Processing Training; Participants in the experimental group will receive computerized exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).
Placebo Comparator: Control Group; Participants in the control group will meet with the examiner the same frequency and for the same duration as those in the experimental group. They will receive placebo control exercises administered on a laptop computer. .	Behavioral: Placebo Control Exercises; Participants in the control group will receive computerized control exercises administered on a laptop computer. They will undergo 12 sessions of 45-60 minutes each (twice a week for 6 weeks).

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Facial Expression Identification Task (FEIT)	The FEIT assesses one's ability to correctly identify and discriminate emotions from faces.	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Emotion Regulation Questionnaire (ERQ)	The ERQ is a self-report measure of the use of 2 emotional regulation strategies: cognitive reappraisal and expressive suppression.	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)
Satisfaction with Life Scale (SWLS)	The SWLS is a self-report measure of quality of life.	Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8)

Collaborators and Investigators

• Sponsor: Kessler Foundation
• Collaborators: New Jersey Commission on Brain Injury Research
• Investigators: Principal Investigator: Helen Genova, PhD, Kessler Foundation

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2015
• Primary Completion (Anticipated): May 1, 2021
• Study Completion (Anticipated): May 1, 2021

Study Registration Dates

• First Submitted: December 8, 2017
• First Submitted That Met QC Criteria: December 8, 2017
• First Posted (Actual): December 14, 2017

Study Record Updates

• Last Update Posted (Actual): February 25, 2021
• Last Update Submitted That Met QC Criteria: February 23, 2021
• Last Verified: February 1, 2021

More Information

Terms related to this study

• Keywords: Cognition; Intervention; Traumatic Brain Injury; Emotional Processing
• Additional Relevant MeSH Terms: Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Wounds and Injuries; Craniocerebral Trauma; Trauma, Nervous System; Brain Injuries; Brain Injuries, Traumatic
• Other Study ID Numbers: R-875-15