- ICH GCP
- Amerikanska kliniska prövningsregistret
- Klinisk prövning 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
Studieöversikt
Status
Betingelser
Intervention / Behandling
Detaljerad beskrivning
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.
Studietyp
Inskrivning (Faktisk)
Fas
- Inte tillämpbar
Kontakter och platser
Studieorter
-
-
Texas
-
Houston, Texas, Förenta staterna, 77030
- Michael E. DeBakey VA Medical Center
-
-
Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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.
Studieplan
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Icke-randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
---|---|
Experimentell: 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.
|
Aktiv 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.
|
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Compliance rates
Tidsram: 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
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
---|---|---|
Improvement in performance over time
Tidsram: 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
Tidsram: At ten weeks
|
Scores on pre- and post- mental health measures will also be related to task performance
|
At ten weeks
|
Samarbetspartners och utredare
Samarbetspartners
Utredare
- Huvudutredare: Mary R Newsome, PhD, Michael E. DeBakey VA Medical Center
Studieavstämningsdatum
Studera stora datum
Studiestart
Primärt slutförande (Faktisk)
Avslutad studie (Faktisk)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Uppskatta)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- H-27735
- 10K09.H (Annan identifierare: MEDVAMC Research & Development Board)
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