Rehabilitation of Executive Functioning in Veterans With PTSD and Mild TBI
| Status: | Completed |
|---|---|
| Conditions: | Hospital, Neurology, Psychiatric, Psychiatric |
| Therapuetic Areas: | Neurology, Psychiatry / Psychology, Other |
| Healthy: | No |
| Age Range: | 18 - 75 |
| Updated: | 2/9/2019 |
| Start Date: | July 31, 2013 |
| End Date: | December 30, 2018 |
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.
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.
The overall aim of this proposal is to investigate the potential short and long term
effectiveness of a cognitive training program Goal-Oriented Attentional Self-regulation
(GOALS) that targets executive control functions in Veterans with co-morbid posttraumatic
stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive
difficulties. Both PTSD and a history of mild TBI are prevalent in Veterans from the
Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts, with reported
rates for each disorder ranging from 14 - 22%. Both PTSD and TBI have been associated with
cognitive dysfunction which may lead to functional impairment and poor community
reintegration. PTSD can be highly debilitating not only due to emotional dysregulation, but
also due to deficits in the cognitive control processes.
Goal-Oriented Attentional Self-Regulation (GOALS) is a therapist administered cognitive
rehabilitation training that targets executive control functions of applied mindfulness-based
attention regulation and goal management, and links them to participant-defined real-life
goals. In a prior study with individuals with chronic brain injury, this training has
improved cognitive performance in areas of complex attention / executive function, memory,
complex functional task performance, and daily functioning. Furthermore, functional MRI
results after training indicated significantly enhanced modulation of neural processing in
extrastriate cortex and changes in prefrontal cortex. Preliminary results from a recently
completed study with Veterans with a history of chronic TBI also support improvements post
GOALS on neuropsychological measures of attention and executive function, performance on
complex 'real-life' tasks, and self-report measures of functional performance. Furthermore,
participants also showed improvement on the emotional regulation self-report measures. These
findings suggest that improving cognitive control may also improve functioning in other
domains such as emotional regulation and functional performance in daily life.
In a randomized, controlled intervention study design, 42 Veterans with a diagnosis of PTSD,
history of mTBI and residual cognitive difficulties will participate in experimental (GOALS),
and/or active comparison (Brain Health Education - EDU) interventions matched for time and
intensity. Participants will be randomized to start with either 5 weeks of GOALS or EDU
training. Those who begin with EDU will cross-over to GOALS, while those begin with GOALS
will have 5 weeks of self-driven practice only. Both groups will participate in pre and post
intervention measurements at baseline, weeks 5 and 10. Long-term follow-up will be at 6
months. Pre- and post-intervention measurements will include performance on untrained:
neuro-cognitive tests assessing targeted and non-targeted cognitive domains, complex
functional task performance in low structure 'real-world' setting, and self-report measures
of emotional regulation and daily functioning.
effectiveness of a cognitive training program Goal-Oriented Attentional Self-regulation
(GOALS) that targets executive control functions in Veterans with co-morbid posttraumatic
stress disorder (PTSD), history of mild traumatic brain injury (mTBI), and cognitive
difficulties. Both PTSD and a history of mild TBI are prevalent in Veterans from the
Operation Enduring Freedom (OEF) and Operation Iraqi Freedom (OIF) conflicts, with reported
rates for each disorder ranging from 14 - 22%. Both PTSD and TBI have been associated with
cognitive dysfunction which may lead to functional impairment and poor community
reintegration. PTSD can be highly debilitating not only due to emotional dysregulation, but
also due to deficits in the cognitive control processes.
Goal-Oriented Attentional Self-Regulation (GOALS) is a therapist administered cognitive
rehabilitation training that targets executive control functions of applied mindfulness-based
attention regulation and goal management, and links them to participant-defined real-life
goals. In a prior study with individuals with chronic brain injury, this training has
improved cognitive performance in areas of complex attention / executive function, memory,
complex functional task performance, and daily functioning. Furthermore, functional MRI
results after training indicated significantly enhanced modulation of neural processing in
extrastriate cortex and changes in prefrontal cortex. Preliminary results from a recently
completed study with Veterans with a history of chronic TBI also support improvements post
GOALS on neuropsychological measures of attention and executive function, performance on
complex 'real-life' tasks, and self-report measures of functional performance. Furthermore,
participants also showed improvement on the emotional regulation self-report measures. These
findings suggest that improving cognitive control may also improve functioning in other
domains such as emotional regulation and functional performance in daily life.
In a randomized, controlled intervention study design, 42 Veterans with a diagnosis of PTSD,
history of mTBI and residual cognitive difficulties will participate in experimental (GOALS),
and/or active comparison (Brain Health Education - EDU) interventions matched for time and
intensity. Participants will be randomized to start with either 5 weeks of GOALS or EDU
training. Those who begin with EDU will cross-over to GOALS, while those begin with GOALS
will have 5 weeks of self-driven practice only. Both groups will participate in pre and post
intervention measurements at baseline, weeks 5 and 10. Long-term follow-up will be at 6
months. Pre- and post-intervention measurements will include performance on untrained:
neuro-cognitive tests assessing targeted and non-targeted cognitive domains, complex
functional task performance in low structure 'real-world' setting, and self-report measures
of emotional regulation and daily functioning.
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
We found this trial at
2
sites
San Francisco, California 94121
Principal Investigator: Tatjana Novakovic-Agopian, PhD
Phone: 415-753-3888
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Martinez, California 94553
Phone: 415-753-3888
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