N/A
N=46
Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI
Post Traumatic Stress Disorder · Mild Traumatic Brain Injury, Concussion
Bottom Line
View on ClinicalTrials.gov: NCT01921179 ↗Enrolled (actual)
46
Serious AEs
0.0%
Results posted
Feb 2020
Primary outcome: Primary: Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training — -0.03; -0.39 z score — p=<0.01
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- GOALS (Goal-Oriented Attentional Regulation) (Behavioral); EDU (Brain Health Education) (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- VA Office of Research and Development
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Performance on Neurocognitive Measure of Attention and Executive Function Post GOALS Intervention vs EDU Control Training |
-0.03; -0.39 | <0.01 sig |
| PRIMARY Long Term Follow-up After GOALS Training - Change in Performance on Neurocognitive Measures of Attention and Executive Function 6+ Months Post GOALS Intervention Relative to Baseline |
-0.2 | <0.001 sig |
| SECONDARY Change in Performance on Complex Functional Task -Goal Processing Scale Post GOALS Intervention vs EDU Control Training |
8.10; 7.60 | >0.05 |
| SECONDARY Long Term Follow-up After GOALS Training - Change in Performance on Complex Functional Task -Goal Processing Scale 6+ Months Post GOALS Intervention Relative to Baseline |
8.23 | <0.001 sig |
| SECONDARY Change on Self Report Measures of Emotional Regulation GOALS Post Intervention vs EDU Control Training |
-1.37; -2.09 | <0.05 sig |
| SECONDARY Long Term Follow-up Change on Self Report Measures of Emotional Regulation 6+ Months Post GOALS Intervention |
-1.01 | <0.01 sig |
Summary
One of the most pressing concerns within the VA currently is the provision of interventions that address the cognitive as well as emotional problems faced by Veterans with concurrent mild TBI and PTSD. One purpose of this study is to learn more about how PTSD and mild brain injury influences how people think, act, and feel. This may include how people pay attention, keep information in memory, organize plans for achieving important goals, and manage stress. Another purpose of this research is to learn more about the effects of cognitive training on the thinking, behavior, and emotions of individuals with PTSD and mild brain injury - both in the short- and long-term. With this research, the investigators hope to better understand and treat cognitive and emotional difficulties that can occur due to PTSD and mild brain injury.
Eligibility Criteria
Inclusion Criteria
- Diagnosis of PTSD
- History of mild TBI, including concussion > 6 months ago
- Cognitive difficulties affecting daily functioning
- Age 18-75
- Veteran
- At least 12th grade education or equivalent
Exclusion Criteria
- Amnesic/Severe memory problems
- Active Substance Abuse/Dependence
- Medical condition that may affect mental status/disrupt study participation
- Active psychotropic medication changes
- Participation in evidence-based PTSD treatment
Data sourced from ClinicalTrials.gov (NCT01921179). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.