Clinical trial NCT03696225: Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD
Official title: Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Posttraumatic Stress Disorder
Keywords: PTSD
Cognitive Function
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2018-10-04
Enrollment: 21
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: This is a parallel randomized controlled pilot trial.
Primary purpose: TREATMENT

Brief summary: 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.

Detailed description: 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006)
timeFrame: change from baseline to 3 and 6 months
measure: Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ; Benedict et al., 2003)
timeFrame: change from baseline to 3 and 6 months
measure: California Verbal Learning Test (CVLT-II; Delis et al., 2000)
timeFrame: change from baseline to 3 and 6 months
measure: Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span & Coding subtests (Wechsler, 2008)
timeFrame: change from baseline to 3 and 6 months
measure: Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983)
timeFrame: change from baseline to 3 and 6 months
measure: Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985)
timeFrame: change from baseline to 3 and 6 months
measure: World Health Organization Disability Assessment Scale (WHODAS 2.0)
timeFrame: change from baseline to 3 and 6 months
measure: Neuro-QOL Cognitive, ability to participate in social roles and activities, and sleep scales
timeFrame: change from baseline to 3 and 6 months
measure: Memory Compensation Questionnaire (MCQ; de Frias & Dixon, 2005)
timeFrame: change from baseline to 3 and 6 months
measure: Portland Cognitive Strategies Scale 2.0 (PCSS)
timeFrame: change from baseline to 3 and 6 months
Secondary outcomes:
measure: Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 2006)
timeFrame: change from baseline to 3 and 6 months
measure: PTSD Checklist (PCL-5; Weathers et al., 2013)
timeFrame: change from baseline to 3 and 6 months
measure: Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999)
timeFrame: change from baseline to 3 and 6 months
Other outcomes:
Locations:
city: Portland
country: United States
facility: VA Portland Health Care System, Portland, OR
state: Oregon
Study officials:
affiliation: VA Portland Health Care System, Portland, OR
name: Maya Elin O'Neil, PhD MS
role: PRINCIPAL_INVESTIGATOR
References: