Recruiting

Emotional Processing

Sponsor:

Kessler Foundation

Code:

NCT03373331

Conditions

Traumatic Brain Injury

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

Emotional Processing Training

Placebo Control Exercises

Study Details

Brief summary:

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.

Conditions

Traumatic Brain Injury

Study ID

NCT03373331

Start date

Sep, 2015

Status verified date

Feb, 2021

Completion date

May, 2021

Anticipated

Primary completion date

May, 2021

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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 Design

Enrollment

50 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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).

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.

.

Interventions

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 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).

Primary outcome measure

  • Facial Expression Identification Task (FEIT) [ Time Frame: Scores will be assessed at two time-points, baseline (week 1) and post-intervention (week 8) ]

Central Contacts and Locations

Central contacts

Angela Smiith, MA

973-324-8448asmith@kesslerfoundation.org

Locations

Kessler Foundation

Recruiting

East Hanover, New Jersey, United States, 07936

More Information

Sponsor

Kessler Foundation

Last update posted

Feb 25, 2021

Last verified

Feb, 2021

Keywords

  • Emotional Processing
  • Cognition
  • Traumatic Brain Injury
  • Intervention

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Kessler Foundation on 2021-02-25.