- ICH GCP
- US-Register für klinische Studien
- Klinische Studie NCT01278316
Rural Veterans With Post-traumatic Stress Disorder (PTSD) And Comorbid Mild Traumatic Brain Injury (TBI): A Feasibility Study
Remote Administration Of Cognitive Training Tasks In Rural Veterans With PTSD And Comorbid Mild TBI: A Feasibility Study
Studienübersicht
Status
Intervention / Behandlung
Detaillierte Beschreibung
Many military personnel have experienced traumatic brain injury (TBI) and posttraumatic stress disorder (PTSD) as a result of the current Afghanistan and Iraq wars. TBI occurs when a sudden force causes the brain to move, causing damage to brain cells. PTSD is an anxiety disorder associated with serious traumatic events. Blast explosions can lead to TBI. People who experience TBI as a result of a blast injury are more likely to experience PTSD than people who have TBI not due to blast. TBI and PTSD may be associated with memory problems in some patients. Because therapy for PTSD sometimes requires learning new ways to think about things and making new responses, being able to remember the new information being learned is important. It is possible that improving memory may also improve PTSD treatment.
This is a prospective study of Operation Enduring Freedom and Operation Iraqi Freedom (Afghanistan and Iraq wars; OEF/OIF) veterans who will undergo two neuropsychological and psychiatric assessments prior and subsequent to a cognitive training intervention. This is a feasibility study to ascertain whether OEF/OIF veterans diagnosed with mild TBI and comorbid PTSD and who live in rural locations will adhere to the schedule demands required of a computer-based cognitive training protocol.
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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Texas
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Houston, Texas, Vereinigte Staaten, 77030
- Michael E. DeBakey VA Medical Center
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-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
Inclusion Criteria:
- Rural residence
- Willingness to commit to the time requirements of the study
- Undergoing treatment for posttraumatic stress disorder (PTSD) as assessed by a clinician, diagnosed with mild traumatic brain injury (TBI)
- Native English speaker
- 20-40 years
- Normal or corrected to normal vision and hearing.
Exclusion Criteria:
- Substance dependence
- Major depression with suicidal ideation
- Psychotic disorder
- History of neurological disorder other than mild traumatic brain injury (TBI) due to blast from Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) (i.e., Afghanistan and Iraq wars) deployment
- History of known or suspected learning disorder.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Nicht randomisiert
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: Cognitive training
Cognitive Intervention Tasks Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks.
Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily.
All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
|
Participants will be asked to perform the Brain Fitness (PositScience) cognitive training tasks an hour each day, five days per week for 8-10 weeks.
Six tasks manipulating auditory and verbal information will be presented, and stimuli from all tasks are presented auditorily.
All tasks are designed to begin with the lowest level of difficulty required to attain 85% accuracy, and as performance improves, difficulty increases to maintain 85% accuracy, with difficulty decreasing if accuracy decreases.
|
|
Aktiver Komparator: Control
The control group will perform computerized tasks that utilize cognitive performance, but were not systematically developed to improve cognitive performance.
|
Participants will be asked to perform computerized tasks that involve auditory and verbal performance one hour each day, five days per week for 8-10 weeks.
Six tasks requiring auditory and verbal information will be presented.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Compliance rates
Zeitfenster: Up to ten weeks
|
Compliance is defined as number of times per week and number of hours per day of task performance
|
Up to ten weeks
|
|
Qualitative assessment
Zeitfenster: Up to ten weeks
|
Participants' reactions to the study will be gathered with Likert scale ratings of perceived problems of delivery, ease of program use, and perceived improvement of cognition.
Open-ended responses to structured questions on likes and dislikes, suggestions for improvement, and overall satisfaction will also be implemented.
|
Up to ten weeks
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
Improvement in performance over time
Zeitfenster: Up to ten weeks
|
Performance at the beginning of the training session of each task will be compared to performance at the completion of the training session of each task.
|
Up to ten weeks
|
|
Relation of performance to mental health
Zeitfenster: At ten weeks
|
Scores on pre- and post- mental health measures will also be related to task performance
|
At ten weeks
|
Mitarbeiter und Ermittler
Ermittler
- Hauptermittler: Mary R Newsome, PhD, Michael E. DeBakey VA Medical Center
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
- Psychische Störungen
- Erkrankungen des Gehirns
- Erkrankungen des zentralen Nervensystems
- Erkrankungen des Nervensystems
- Wunden und Verletzungen
- Kraniozerebrales Trauma
- Trauma, Nervensystem
- Trauma- und stressbedingte Störungen
- Hirnverletzungen
- Belastungsstörungen, traumatisch
- Belastungsstörungen, posttraumatisch
- Hirnverletzungen, traumatisch
Andere Studien-ID-Nummern
- H-27735
- 10K09.H (Andere Kennung: MEDVAMC Research & Development Board)
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