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

Primary Purpose

Posttraumatic Stress Disorder

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Compensatory Cognitive Training (CCT)
Treatment as Usual (TAU)
Sponsored by
VA Office of Research and Development
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Posttraumatic Stress Disorder focused on measuring PTSD, Cognitive Function

Eligibility Criteria

18 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • VA Portland Health Care System, Portland, ORRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Compensatory Cognitive Training (CCT)

Treatment as Usual (TAU)

Arm Description

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).

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).

Outcomes

Primary Outcome Measures

Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006)
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)
Cognitive symptoms. Higher scores represent worse outcomes. Total score ranges from 0-60.
California Verbal Learning Test (CVLT-II; Delis et al., 2000)
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)
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)
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)
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)
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
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)
compensatory cognitive strategy use. Higher scores represent better outcomes. Total score ranges from 0-176.
Portland Cognitive Strategies Scale 2.0 (PCSS)
compensatory cognitive strategy use. Higher scores represent worse outcomes. Total score ranges from 0-60.

Secondary Outcome Measures

Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 2006)
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)
PTSD symptoms and severity. Higher scores represent worse outcomes. Total score ranges from 0-80.
Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999)
depression symptoms and severity. Higher scores represent worse outcomes. Total score ranges from 0-27.

Full Information

First Posted
October 3, 2018
Last Updated
October 11, 2023
Sponsor
VA Office of Research and Development
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1. Study Identification

Unique Protocol Identification Number
NCT03696225
Brief Title
Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD
Acronym
CCTPTSD
Official Title
Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 6, 2019 (Actual)
Primary Completion Date
September 29, 2024 (Anticipated)
Study Completion Date
December 29, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
VA Office of Research and Development

4. Oversight

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
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Posttraumatic Stress Disorder
Keywords
PTSD, Cognitive Function

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
This is a parallel randomized controlled pilot trial.
Masking
Outcomes Assessor
Masking Description
Assessors will be masked to participant condition.
Allocation
Randomized
Enrollment
36 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Compensatory Cognitive Training (CCT)
Arm Type
Experimental
Arm Description
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).
Arm Title
Treatment as Usual (TAU)
Arm Type
Active Comparator
Arm Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Compensatory Cognitive Training (CCT)
Other Intervention Name(s)
CCT
Intervention Description
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).
Intervention Type
Behavioral
Intervention Name(s)
Treatment as Usual (TAU)
Other Intervention Name(s)
TAU
Intervention Description
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).
Primary Outcome Measure Information:
Title
Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006)
Description
Cognitive symptoms. Higher scores represent worse outcomes. Total score ranges from 0-64.
Time Frame
change from baseline to 3 and 6 months
Title
Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ; Benedict et al., 2003)
Description
Cognitive symptoms. Higher scores represent worse outcomes. Total score ranges from 0-60.
Time Frame
change from baseline to 3 and 6 months
Title
California Verbal Learning Test (CVLT-II; Delis et al., 2000)
Description
verbal learning and memory; forced choice validity. Total score ranges from 0-80. Higher scores represent better outcomes.
Time Frame
change from baseline to 3 and 6 months
Title
Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span & Coding subtests (Wechsler, 2008)
Description
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.
Time Frame
change from baseline to 3 and 6 months
Title
Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983)
Description
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.
Time Frame
change from baseline to 3 and 6 months
Title
Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985)
Description
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.
Time Frame
change from baseline to 3 and 6 months
Title
World Health Organization Disability Assessment Scale (WHODAS 2.0)
Description
quality of life, global functioning. Higher scores represent worse outcomes. Total score ranges from 0-48.
Time Frame
change from baseline to 3 and 6 months
Title
Neuro-QOL Cognitive, ability to participate in social roles and activities, and sleep scales
Description
quality of life, cognitive functioning, sleep functioning, social functioning. Higher scores represent better outcomes. Scores on each subtest range from 8-40.
Time Frame
change from baseline to 3 and 6 months
Title
Memory Compensation Questionnaire (MCQ; de Frias & Dixon, 2005)
Description
compensatory cognitive strategy use. Higher scores represent better outcomes. Total score ranges from 0-176.
Time Frame
change from baseline to 3 and 6 months
Title
Portland Cognitive Strategies Scale 2.0 (PCSS)
Description
compensatory cognitive strategy use. Higher scores represent worse outcomes. Total score ranges from 0-60.
Time Frame
change from baseline to 3 and 6 months
Secondary Outcome Measure Information:
Title
Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 2006)
Description
mental health diagnoses. Scores are indicative of presence or absence of a diagnosis (categorical variable, therefore no range of scores is applicable).
Time Frame
change from baseline to 3 and 6 months
Title
PTSD Checklist (PCL-5; Weathers et al., 2013)
Description
PTSD symptoms and severity. Higher scores represent worse outcomes. Total score ranges from 0-80.
Time Frame
change from baseline to 3 and 6 months
Title
Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999)
Description
depression symptoms and severity. Higher scores represent worse outcomes. Total score ranges from 0-27.
Time Frame
change from baseline to 3 and 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Maya E O'Neil, PhD MS
Phone
(503) 220-8262
Ext
54522
Email
Maya.Oneil@va.gov
First Name & Middle Initial & Last Name or Official Title & Degree
Emily R Sano, MA
Phone
(503) 220-8262
Ext
58290
Email
emily.sano@va.gov
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Maya Elin O'Neil, PhD MS
Organizational Affiliation
VA Portland Health Care System, Portland, OR
Official's Role
Principal Investigator
Facility Information:
Facility Name
VA Portland Health Care System, Portland, OR
City
Portland
State/Province
Oregon
ZIP/Postal Code
97207-2964
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Archie (Herman) G Bouwer, PhD
Phone
(503) 220-8262
Ext
52900
Email
Archie.Bouwer@va.gov
First Name & Middle Initial & Last Name & Degree
Maya Elin O'Neil, PhD MS

12. IPD Sharing Statement

Plan to Share IPD
No

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Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

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