TBI 및 PTSD가 있는 재향군인의 감정 의사소통을 개선하기 위한 혁신적인 다중 모드 및 주의력 교육
Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Currently there are no interventions for emotion recognition in Veterans with mTBI and PTSD, and interventions for severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise but lacked attention training that is an essential component in recognizing emotions in our daily lives. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a study is needed to determine the effectiveness of a MMART combined with attention training.
연구 개요
상태
정황
상세 설명
Background. Deficits in emotion recognition are common in traumatic brain injury (TBI) and in post-traumatic stress disorder (PTSD) but these deficits have not been well studied in Veterans with both mild TBI (mTBI) and PTSD. Poor emotion recognition has been associated with poor quality of interpersonal relationships, loss of employment, behavioral problems, reduced social reintegration, social isolation and even suicide. Currently there are no interventions for emotion recognition deficits in Veterans with mTBI and PTSD, and interventions conducted in civilians with severe TBI have lacked training of both facial and vocal emotion recognition. In a preliminary study of an innovative combination of facial and vocal modalities, a multimodal affect recognition training (MMART) showed promise with significant improvement on the Florida Affect Battery (FAB) but lacked attention training that is an essential component in recognizing rapidly changing emotions in our everyday lives. Attention training using Brain HQ targets the required attention factors underlying emotion recognition. Given the need to improve relationships and productivity in Veterans with mTBI and PTSD, a randomized controlled trial is needed to determine the effectiveness of an innovative MMART combined with attention training to improve emotion recognition and everyday function.
Objective & Hypotheses. The objective of this randomized controlled trial is to determine the treatment effect of a MultiModal Affect Recognition Training (MMART) combined with attention training in Veterans with TBI/PTSD.
Hypothesis 1. MMART combined with attention training will significantly improve performance on tests of emotion recognition.
Hypothesis 2: Treatment gains will translate to functional activities. Primary measures. Florida Affect Battery (FAB) and the Community Reintegration in Service members (CRIS).
Secondary measures. Emotion Recognition Task (ERT), attention index of the Repeatable Battery for the Assessment of Neuropsychological Status (RBANS), the Continuous Performance Task and the TBI Quality of Life (TBI-QOL) Ability to Participate in Social Roles and Activities.
Methods. 20 Veterans with mTBI and PTSD will be randomized to either the combined training or an inactive control group. Both groups will attend 16, one-hour in-person sessions over 8 weeks. Outcomes will be assessed at pre-, post-, 3 month-post-treatment. A linear regression will be used to determine significant improvement of the treatment group over the control group, with t-tests to demonstrate within group improvement. Effect size calculations will be used to determine the power needed for a future Merit proposal.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Florida
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Gainesville, Florida, 미국, 32608-1135
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Veterans with a diagnosis of mTBI and PTSD based on VA/Department of Defense guidelines.
- Emotion recognition deficit
- Attention deficit
- Corrected vision within normal limits
- Hearing within normal limits
- Fluent in English
Exclusion Criteria:
- Premorbid history of schizophrenia
- Bipolar disorder
- Chronic medical or neurological diseases
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
|
실험적: MMART and attention training
Training to recognize affect and prosodic expressions of emotions combined with attention training. |
8 session, trains participants to recognize expression of emotion from a variety of stimuli, including dynamic stimuli (e.g., video instead of still pictures) and it employs both facial and vocal examples of emotion expression.
다른 이름들:
computerized attention drill training
다른 이름들:
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위약 비교기: Brain Health Workshop and National Geographic Movies
an inactive arm that matches sessions of intervention. BHW is education about the brain and cognition. National Geographic movies are viewed with the clinician and the participant answers questions about the movies. |
an education presentation on brain function and cognitive principles of learning with homework and quizzes on information covered.
다른 이름들:
participant will watch movies and answer questions after
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Florida Affect Battery (FAB), assessing change
기간: week 1, week 11, week 22
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A standardized assessment of emotional affect and prosody recognition. normative scores range from 0-100 for each of the 12 subscales. Higher scores indicate better emotion recognition. |
week 1, week 11, week 22
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Community Reintegration of Service Members, assessing change
기간: week 1, week 11, week 22
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Satisfaction questionnaire of community participation. Scores range from .43 to 2.15. 43 items with five rating options of 1-5. Higher scores indicate better community participation. |
week 1, week 11, week 22
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Emotion Recognition Task, assessing change
기간: week 1, week 11, week 22
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Computerized assessment of emotional affect recognition. Correct responses range from 0-48 (higher scores indicate better emotion recognition) and correct response time ranges from 0 to infinity (lower scores indicate quicker response time). |
week 1, week 11, week 22
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Continuous Performance Task, assessing change
기간: week 1, week 11, week 22
|
Computerized measures of sustained attention. 100 trials with accuracy ranging from 0-100 (higher scores indicate better attention) and response time from 0-60 (lower scores indicate quicker response time). |
week 1, week 11, week 22
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Attention Index of the Repeatable Battery for the Assessment of Neuropsychological Status, assessing change
기간: week 1, week 11, week 22
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Digit span and symbol digit to assess attention. Scaled scores range from 1-19, with higher scores indicating better attention. |
week 1, week 11, week 22
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Traumatic Brain injury quality of life
기간: week 1, week 11, week 22
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Quality of life questionnaire about community participation. 59 items with scores ranging from 59-295, with higher scores indicating better community participation. |
week 1, week 11, week 22
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공동 작업자 및 조사자
수사관
- 수석 연구원: Julia K. Waid-Ebbs, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- D4411-P
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Final data sets will be maintained locally and a de-identified, anonymized dataset will be made available in response to specific requests that meet the criteria described within this document and to data repositories i.e. FITBIR.
IPD 공유 기간
at closure of study and as long as FITBIR retains the data
IPD 공유 액세스 기준
dependent on FITBIR criteria
IPD 공유 지원 정보 유형
- ANALYTIC_CODE
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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