Inovativní multimodální školení a školení pozornosti ke zlepšení emoční komunikace u veteránů s TBI a 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. 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.
Přehled studie
Postavení
Detailní popis
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.
Typ studie
Zápis (Aktuální)
Fáze
- Nelze použít
Kontakty a umístění
Studijní místa
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Florida
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Gainesville, Florida, Spojené státy, 32608-1135
- North Florida/South Georgia Veterans Health System, Gainesville, FL
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Kritéria účasti
Kritéria způsobilosti
Věk způsobilý ke studiu
Přijímá zdravé dobrovolníky
Pohlaví způsobilá ke studiu
Popis
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
Studijní plán
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Žádné (otevřený štítek)
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: 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.
Ostatní jména:
computerized attention drill training
Ostatní jména:
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Komparátor placeba: 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.
Ostatní jména:
participant will watch movies and answer questions after
Ostatní jména:
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Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Florida Affect Battery (FAB), assessing change
Časové okno: 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
Časové okno: 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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Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
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Emotion Recognition Task, assessing change
Časové okno: 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
Časové okno: week 1, week 11, week 22
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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
Časové okno: 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
Časové okno: 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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Spolupracovníci a vyšetřovatelé
Vyšetřovatelé
- Vrchní vyšetřovatel: Julia K. Waid-Ebbs, PhD, North Florida/South Georgia Veterans Health System, Gainesville, FL
Termíny studijních záznamů
Hlavní termíny studia
Začátek studia (Aktuální)
Primární dokončení (Aktuální)
Dokončení studie (Odhadovaný)
Termíny zápisu do studia
První předloženo
První předloženo, které splnilo kritéria kontroly kvality
První zveřejněno (Aktuální)
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
Naposledy ověřeno
Více informací
Termíny související s touto studií
Další relevantní podmínky MeSH
- Trauma a poruchy související se stresem
- Onemocnění mozku
- Onemocnění centrálního nervového systému
- Nemoci nervového systému
- Duševní poruchy
- Rány a zranění
- Kraniocerebrální trauma
- Trauma, nervový systém
- Stresové poruchy, traumatické
- Poranění mozku
- Stresové poruchy, posttraumatické
- Technologie, průmysl a zemědělství
- Technologie
- Audiovizuální pomůcky
- Vzdělávací technologie
- Filmové snímky
Další identifikační čísla studie
- D4411-P
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
Popis plánu IPD
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.
Časový rámec sdílení IPD
at closure of study and as long as FITBIR retains the data
Kritéria přístupu pro sdílení IPD
dependent on FITBIR criteria
Typ podpůrných informací pro sdílení IPD
- ANALYTIC_CODE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Studuje produkt zařízení regulovaný americkým úřadem FDA
produkt vyrobený a vyvážený z USA
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