Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03169647
Recruitment Status : Recruiting
First Posted : May 30, 2017
Last Update Posted : August 21, 2017
Information provided by (Responsible Party):
Kessler Foundation

April 11, 2017
May 30, 2017
August 21, 2017
August 17, 2017
June 30, 2018   (Final data collection date for primary outcome measure)
Goodman and Kruskal gamma coefficient on MRI-based metacognitive task [ Time Frame: 7 weeks ]
While participants are in the scanner, they will perform a metamemory paradigm that involves the completion of 2 components per trial: 1) a memory task (a non-verbal recognition task), and 2) a metacognitive task that immediately follows completion of every recognition item. Accuracy of metacognitive functioning can be quantified using the Goodman and Kruskal gamma coefficient,16 a value between -1 and 1, indicating the discrepancy between the participant's judgment and objective performance that is commonly used in the metacognitive literature.
Same as current
Complete list of historical versions of study NCT03169647 on Archive Site
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Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
Evaluating the Effectiveness of Treatment for Metacognition in Moderate and Severe Traumatic Brain Injury
Metacognition, in-the-moment awareness of performance while engaging in cognitive tasks, is negatively affected by traumatic brain injury (TBI). Metacognitive deficits can greatly reduce quality of life for individuals with TBI as functioning in this domain has been closely linked with successful independent living and community re-integration. Problematically, there are currently no empirically validated treatment options that address metacognitive deficits after TBI. Recent research in healthy samples demonstrates that specific listening interventions may alter neural activation in brain works associated with metacognition and can improve metacognitive functioning; however, it remains unknown if these effects generalize to individuals with TBI. Thus, the objective of the proposed study is to use a double-blind, placebo controlled randomized clinical trial to determine the efficacy of applying a specific listening intervention to improve metacognition after TBI and to employ functional magnetic resonance imaging (fMRI) to document the neural mechanisms by which the intervention operates.
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Outcomes Assessor)
Primary Purpose: Treatment
Brain Injuries, Traumatic
Behavioral: Listening-based intervention
Participants will listen to pre-specified material on a CD
  • Experimental: Intervention
    listening-based protocol (type A)
    Intervention: Behavioral: Listening-based intervention
  • Placebo Comparator: Control
    listening-based protocol (type B)
    Intervention: Behavioral: Listening-based intervention
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*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Same as current
June 30, 2018
June 30, 2018   (Final data collection date for primary outcome measure)

Inclusion Criteria:

  • diagnosis of moderate or severe brain injury
  • between the ages of 18 and 59.
  • able to read and speak English fluently.
  • TBI at least 1 year ago.

Exclusion Criteria:

  • pregnant.
  • left-handed.
  • color-blind.
  • diagnosed with significant psychiatric illness (e.g., bipolar, schizophrenia).
  • receiving or have received inpatient and/or rehabilitative treatment for substance use.
  • diagnosis of a neurological condition other than TBI (e.g., epilepsy, multiple sclerosis, stroke).
  • any metal in my body that has not been declared MRI-safe by my physician.
  • impaired independent use of either hand.
  • any of the following in/on my body that may interfere with MRI: pacemaker, implanted electrical devices, brain stimulators, particular types of dental implants, aneurysm clips, metallic prostheses (including metal pins and rods, heart valves, and internal hearing aids), permanent eyeliner, implanted delivery pumps, or shrapnel fragments.
  • history of engaging in welding and/or metal working activities.
  • formal training or am a current practitioner of yoga, meditation, and/or mindfulness.
  • currently involved in any other type of thinking skills and/or emotional treatment, such as psychotherapy.
Sexes Eligible for Study: All
18 Years to 59 Years   (Adult)
Contact: Erica Weber, PhD 973-324-8451
Contact: Nancy Chiaravalloti, PhD
United States
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: No
Kessler Foundation
Kessler Foundation
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Kessler Foundation
August 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP