Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

Status

Completed

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03696225

Acronym

CCTPTSD

Enrollment

Registered

2018-10-04

Start date

2019-03-06

Completion date

2025-12-29

Last updated

2026-01-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD, Cognitive Function

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.

Interventions

BEHAVIORALCompensatory 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).

BEHAVIORALTreatment 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 design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Outcomes Assessor)

Masking description

Assessors will be masked to participant condition.

Intervention model description

This is a parallel randomized controlled pilot trial.

Eligibility

Sex/Gender

ALL

Age

18 Years to 75 Years

Healthy volunteers

Inclusion criteria

* Eligible Veterans must meet Diagnostic and Statistical Manual 5 (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 (tbi) of any severity or another major medical condition likely to significantly impact cognitive functioning such as stroke, multiple sclerosis (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.

Design outcomes

Primary

Measure	Time frame	Description
California Verbal Learning Test (CVLT-II; Delis et al., 2000)	change from baseline to 3 and 6 months	Comprehensive measurement of verbal learning and memory and includes a forced choice validity. The total raw score is the sum of correct responses on the five presentations; scores range from 0-80. Higher scores represent better outcomes.
Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006)	change from baseline to 3 and 6 months	Self-report severity measure of prospective (remembering to do something in the future) and retrospective (remembering something from the past) memory problems relevant to every day life. Higher scores represent worse outcomes. Total score ranges from 0-64.
Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ; Benedict et al., 2003)	change from baseline to 3 and 6 months	Self-report severity measure of attention and organizational problems. Scores on the MSNQ range from 0 to 58, with higher scores indicating greater cognitive impairment.
Wechsler Adult Intelligence Scale (WAIS-IV) Coding Subtest (Wechsler, 2008)	change from baseline to 3 and 6 months	A measure of processing speed. Higher scores represent better outcomes. Scores range from 0-155.
Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983)	change from baseline to 3 and 6 months	The Controlled Oral Word Association (COWA) Test measures word generation, verbal fluency, and executive functioning. Participants are asked to name as many words as they can starting with a specific letter (i.e., F, A, S) within one minute, and as many words as possible in a specified category (i.e., animals) within one minute. Total score is the sum of responses (three letter trials, one category trial). Higher scores represent better outcomes. Total score ranges are affected by age and education.
Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985)	change from baseline to 3 and 6 months	Measures visual tracking, processing speed, and executive functioning. Scores represent the amount of time to complete the task (in seconds), range from 10-366, and higher numbers represent worse outcomes.
World Health Organization Disability Assessment Scale (WHODAS 2.0)	change from baseline to 3 and 6 months	Self-report measure of quality of life and global functioning. Higher scores represent worse outcomes. Total score ranges from 0-144.
Quality of Life in Neurological Disorders (Neuro-QOL): Cognitive, Ability to Participate in Social Roles and Activities, and Sleep Scales	change from baseline to 3 and 6 months	Self-report measure of quality of life, cognitive functioning, sleep functioning, and social functioning. Higher scores represent lower functioning. Total scores range from 52 to 260.
Memory Compensation Questionnaire (MCQ; de Frias & Dixon, 2005)	change from baseline to 3 and 6 months	A 44-item self-report questionnaire that rates the extent of use of various strategies to improve memory performance relevant to daily living. Higher scores represent better outcomes. Total score ranges from 0-176.
Portland Cognitive Strategies Scale 2.0 (PCSS)	change from baseline to 3 and 6 months	Measures compensatory cognitive strategy use through two scales; how often skills are used and how useful. Higher scores represent more skill use and more perceived usefulness. Total score ranges from 0-60 per scale.
Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span Subtest (Wechsler, 2008)	change from baseline to 3 and 6 months	Measures attention, working memory, processing speed, and reliable digit span validity. Higher scores represent better outcomes. Scores on each subtest (forward, backward, and sequential) range from 0-16 and are reported as WAIS Scaled Scores. Total score (range 0-48) is the sum of each subtest.

Secondary

Measure	Time frame	Description
PTSD Checklist (PCL-5; Weathers et al., 2013)	change from baseline to 3 and 6 months	PTSD symptoms and severity. Higher scores indicates more severe symptomology. Total score ranges from 0-80.
Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999)	change from baseline to 3 and 6 months	A brief, nine-item depression assessment questionnaire used to screen for depression and monitor its severity. Higher scores represent worse outcomes. Total score ranges from 0-27.

Countries

United States

Contacts

PRINCIPAL_INVESTIGATORMaya Elin O'Neil, PhD MS

VA Portland Health Care System, Portland, OR

Participant flow

Participants by arm

Arm	Count
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).	13
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).	8
Total	21

Baseline characteristics

Characteristic	Compensatory Cognitive Training (CCT)	Treatment as Usual (TAU)	Total
Age, Continuous	45 years STANDARD_DEVIATION 12.89	45.63 years STANDARD_DEVIATION 14.3	45.3 years STANDARD_DEVIATION 13.1
Education (years)	14.31 years STANDARD_DEVIATION 1.93	15.75 years STANDARD_DEVIATION 2.44	14.86 years STANDARD_DEVIATION 2.2
Mental Health Diagnosis Agoraphobia	9 Participants	3 Participants	12 Participants
Mental Health Diagnosis Alcohol Use Disorder	2 Participants	0 Participants	2 Participants
Mental Health Diagnosis Generalized Anxiety Disorder	5 Participants	1 Participants	6 Participants
Mental Health Diagnosis Major Depressive Disorder	7 Participants	4 Participants	11 Participants
Mental Health Diagnosis Panic Disorder	5 Participants	1 Participants	6 Participants
Mental Health Diagnosis PTSD	13 Participants	6 Participants	19 Participants
Mental Health Diagnosis Social Anxiety	5 Participants	2 Participants	7 Participants
Race/Ethnicity, Customized Native American	0 Participants	1 Participants	1 Participants
Race/Ethnicity, Customized Non-Hispanic Black	0 Participants	2 Participants	2 Participants
Race/Ethnicity, Customized Non-Hispanic White	13 Participants	4 Participants	17 Participants
Race/Ethnicity, Customized Other	0 Participants	1 Participants	1 Participants
Region of Enrollment United States	13 Participants	8 Participants	21 Participants
Sex: Female, Male Female	8 Participants	2 Participants	10 Participants
Sex: Female, Male Male	5 Participants	6 Participants	11 Participants

Adverse events

Event type	EG000 affected / at risk	EG001 affected / at risk
deaths Total, all-cause mortality	0 / 13	0 / 8
other Total, other adverse events	0 / 13	0 / 13
serious Total, serious adverse events	0 / 13	0 / 8

Outcome results

Primary

California Verbal Learning Test (CVLT-II; Delis et al., 2000)

Comprehensive measurement of verbal learning and memory and includes a forced choice validity. The total raw score is the sum of correct responses on the five presentations; scores range from 0-80. Higher scores represent better outcomes.