Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

Sponsor:

Collaborators:

Information provided by (Responsible Party):

，

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

January 7, 2019

Estimated Primary Completion Date

September 29, 2023 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006)[ Time Frame: change from baseline to 3 and 6 months ]

Cognitive symptoms. Higher scores represent worse outcomes. Total score ranges from 0-64.

Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ; Benedict et al., 2003)[ Time Frame: change from baseline to 3 and 6 months ]

Cognitive symptoms. Higher scores represent worse outcomes. Total score ranges from 0-60.

California Verbal Learning Test (CVLT-II; Delis et al., 2000)[ Time Frame: change from baseline to 3 and 6 months ]

verbal learning and memory; forced choice validity. Total score ranges from 0-80. Higher scores represent better outcomes.

Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span & Coding subtests (Wechsler, 2008)[ Time Frame: change from baseline to 3 and 6 months ]

attention, working memory, processing speed, reliable digit span validity. Higher scores represent better outcomes. Scores on each subtest range from 0-18 and are reported as WAIS Scaled Scores.

Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983)[ Time Frame: change from baseline to 3 and 6 months ]

word generation, verbal fluency, executive functioning. Higher scores represent better outcomes. Total score ranges from 0-infinite, but are reported as t-scores with a range of 0-100.

Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985)[ Time Frame: change from baseline to 3 and 6 months ]

visual tracking, processing speed, executive functioning. Higher scores are the amount of time to complete the task and represent worse outcomes. Total scores are in seconds, but are converted to t-scores ranging from 0-100 with higher scores representing better outcomes once converted to t-scores.

World Health Organization Disability Assessment Scale (WHODAS 2.0)[ Time Frame: change from baseline to 3 and 6 months ]

quality of life, global functioning. Higher scores represent worse outcomes. Total score ranges from 0-48.

Neuro-QOL Cognitive, ability to participate in social roles and activities, and sleep scales[ Time Frame: change from baseline to 3 and 6 months ]

quality of life, cognitive functioning, sleep functioning, social functioning. Higher scores represent better outcomes. Scores on each subtest range from 8-40.

Memory Compensation Questionnaire (MCQ; de Frias & Dixon, 2005)[ Time Frame: change from baseline to 3 and 6 months ]

compensatory cognitive strategy use. Higher scores represent better outcomes. Total score ranges from 0-176.

Portland Cognitive Strategies Scale 2.0 (PCSS)[ Time Frame: change from baseline to 3 and 6 months ]

compensatory cognitive strategy use. Higher scores represent worse outcomes. Total score ranges from 0-60.

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 2006)[ Time Frame: change from baseline to 3 and 6 months ]
mental health diagnoses. Scores are indicative of presence or absence of a diagnosis (categorical variable, therefore no range of scores is applicable).
PTSD Checklist (PCL-5; Weathers et al., 2013)[ Time Frame: change from baseline to 3 and 6 months ]
PTSD symptoms and severity. Higher scores represent worse outcomes. Total score ranges from 0-80.
Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999)[ Time Frame: change from baseline to 3 and 6 months ]
depression symptoms and severity. Higher scores represent worse outcomes. Total score ranges from 0-27.

Descriptive Information

Brief Title ^ICMJE

Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

Official Title ^ICMJE

Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

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.

Study Type ^ICMJE

Interventional

Study Phase

N/A

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a parallel randomized controlled pilot trial.
Masking: Interventional
Masking Description:Assessors will be masked to participant condition.
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Behavioral: Compensatory Cognitive Training (CCT)
Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016).
Behavioral: Treatment as Usual (TAU)
All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment).

Study Arms

Experimental: Compensatory Cognitive Training (CCT)
Compensatory Cognitive Training draws from the theoretical literature on compensatory strategy training for other cognitively impaired populations (e.g., Huckans et al., 2013; Twamley et al., 2010; Storzbach et al., 2016). It is a rehabilitation model that aims to teach individuals strategies that allow them to work around cognitive deficits. Consistent with this model and the expert recommendations for civilians and Service members with TBI (Cicerone, 2011), manualized CCT treatment provides training in compensatory attention and learning/memory skills, formal problem-solving strategies applied to daily problems, and the use of external aids such as calendar systems and assistive devices to promote completion of daily tasks (Storzbach et al., 2016).
Active Comparator: Treatment as Usual (TAU)
All TAU participants have an ongoing VA mental health provider and received ongoing mental health care during the course of the study (generally weekly individual or group sessions focusing on evidence-based PTSD treatment).

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 29, 2023

Estimated Primary Completion Date

September 29, 2023 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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.

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

，

Study Sponsor ^ICMJE

VA Office of Research and Development

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Maya Elin O'Neil, PhD MS VA Portland Health Care System, Portland, OR

PRS Account

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

请使用微信扫码报名