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Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD (CCTPTSD)

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ClinicalTrials.gov Identifier: NCT03696225
Recruitment Status : Recruiting
First Posted : October 4, 2018
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

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.

Condition or disease Intervention/treatment Phase
Posttraumatic Stress Disorder Behavioral: Compensatory Cognitive Training (CCT) Behavioral: Treatment as Usual (TAU) Not Applicable

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 36 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: This is a parallel randomized controlled pilot trial.
Masking: Single (Outcomes Assessor)
Masking Description: Assessors will be masked to participant condition.
Primary Purpose: Treatment
Official Title: Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD
Actual Study Start Date : March 6, 2019
Estimated Primary Completion Date : September 29, 2023
Estimated Study Completion Date : December 29, 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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).
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).
Other Name: CCT

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).
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).
Other Name: TAU




Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

  9. 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.

  10. 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.


Secondary Outcome Measures :
  1. 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).

  2. 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.

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03696225


Contacts
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Contact: Maya E O'Neil, PhD MS (503) 220-8262 ext 54522 Maya.Oneil@va.gov
Contact: Marilyn Huckans, PhD (503) 220-8262 ext 54689 marilyn.huckans@va.gov

Locations
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United States, Oregon
VA Portland Health Care System, Portland, OR Recruiting
Portland, Oregon, United States, 97239
Contact: Archie (Herman) G Bouwer, PhD    (503) 220-8262 ext 52900    Archie.Bouwer@va.gov   
Contact: Michael P Davey, MD PhD    (503) 273-5125    michael.davey@va.gov   
Principal Investigator: Maya Elin O'Neil, PhD MS         
Sponsors and Collaborators
VA Office of Research and Development
Investigators
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Principal Investigator: Maya Elin O'Neil, PhD MS VA Portland Health Care System, Portland, OR

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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT03696225     History of Changes
Other Study ID Numbers: D2762-W
1IK2RX002762-01A1 ( U.S. NIH Grant/Contract )
First Posted: October 4, 2018    Key Record Dates
Last Update Posted: August 22, 2019
Last Verified: August 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by VA Office of Research and Development:
PTSD
Cognitive Function

Additional relevant MeSH terms:
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Stress Disorders, Post-Traumatic
Stress Disorders, Traumatic
Trauma and Stressor Related Disorders
Mental Disorders