Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD



Status:Recruiting
Conditions:Psychiatric
Therapuetic Areas:Psychiatry / Psychology
Healthy:No
Age Range:18 - 60
Updated:3/13/2019
Start Date:March 6, 2019
End Date:December 29, 2023
Contact:Maya E O'Neil, PhD MS
Email:Maya.Oneil@va.gov
Phone:(503) 220-8262

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Approximately half a million Veterans receiving services at the VA have Posttraumatic Stress
Disorder (PTSD). PTSD is strongly associated with cognitive functioning deficits in areas of
concentration, attention, memory, learning, verbal abilities, processing speed, and
multitasking. Compensatory Cognitive Training (CCT) is an evidence-based intervention for
cognitive problems that is effective in other Veteran populations such as those with a
history of traumatic brain injury (TBI), but CCT has not yet been tested in Veterans with
PTSD who don't have a history of TBI. The investigators will conduct a pilot randomized
controlled trial (RCT) of CCT in Veterans who have been treated for PTSD but continue to have
cognitive functioning deficits. The investigators will examine feasibility, acceptability,
participant characteristics, and effect size estimates in preparation for a fully-powered RCT
of CCT for PTSD-related cognitive functioning deficits.

Project Background: PTSD is associated with deficits in cognitive functioning including
memory, learning, processing speed, concentration, attention, and executive functioning.
Though many Veterans benefit from evidence-based psychotherapy (EBP) for PTSD, many Veterans
have cognitive functioning deficits even after completing EBP for PTSD. There are no
evidence-based treatments for these Veterans. Compensatory Cognitive Training (CCT) is
improves cognitive functioning in Veterans with brain injury history, but is not yet tested
in Veterans with PTSD.

Project Aims: This study will evaluate feasibility, acceptability, and participant
characteristics, and estimate effect sizes, in a pilot test of CCT for Veterans with
PTSD-related cognitive problems. Data from this study will form the basis for a future, fully
powered trial testing the effectiveness of CCT for cognitive problems in Veterans with PTSD.

Project Methods: The investigators will recruit Veterans from local VA mental health clinics,
using the VA's Corporate Data Warehouse (CDW) to identify potentially eligible Veterans if
needed. The investigators will compare CCT vs. treatment as usual for 36 Veterans with
PTSD-related cognitive functioning deficits. The investigators will calculate rates of
recruitment, retention, and intervention participation. Statistical significance will be
examined, though the investigators' focus will be on effect size estimates, score ranges, and
variability to plan for a follow-up, fully powered RCT.

Anticipated Impact: PTSD-related cognitive functioning deficits are a significant problem for
many Veterans. CCT is an effective cognitive rehabilitation intervention for Veterans with a
history of brain injury, but VA clinicians need data on its effectiveness for Veterans with
PTSD-related cognitive functioning deficits. These studies will provide the data necessary
for a larger scale RCT proposal if results show that CCT is as promising as expected for
Veterans with PTSD.

Inclusion Criteria:

- Eligible Veterans must meet DSM-5 criteria for PTSD with evidence-based PTSD treatment
participation within the past 2 years.

- Must have an individual mental health provider/case manager assigned for coordination
of care and management of crises as well as provision of treatment as usual if Veteran
is randomly assigned to this condition.

- Report subjective cognitive complaints, such as problems with memory,
attention/concentration, and executive function (e.g., planning, organization,
problem-solving, decision-making).

- Referring provider observes mild cognitive problems that interfere with daily life
(e.g., forgetting appointments or medications, poor performance at work or school,
difficulty remembering information, trouble focusing in treatment sessions, trouble
following through on goals).

- Fluent English speaker.

- Able to read and write and provide informed consent.

Exclusion Criteria:

- No history of traumatic brain injury (of any severity) or another major medical
condition likely to significantly impact cognitive functioning such as stroke, MS,
Parkinson's, or a brain tumor.

- Do not meet criteria for bipolar disorder or a psychotic disorder. Do not have a
diagnosis of a substance dependence disorder within the past 30 days.

- Do not have active suicidal intent indicating significant clinical risk (which would
suggest that a treatment targeting suicidal intent is indicated).

- Cognitive problems are not severe (i.e., no dementia). Cognitive problems do NOT
interfere with a Veteran's overall ability to live independently or care for
him/herself.

- Not currently participating in any type of brain stimulation treatment.

- No significant auditory/visual impairments.
We found this trial at
1
site
Portland, Oregon 97201
Principal Investigator: Maya Elin O'Neil, PhD MS
Phone: (503) 220-8262
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mi
from
Portland, OR
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