Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

NCT03696225 | Completed Results

• 2 other identifiers: D2762-W1IK2RX002762-01A1
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

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.

Conditions

Posttraumatic Stress Disorder

Keywords

PTSD; Cognitive Function

Outcome Measures

Primary Outcomes (11)

• Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006)

  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.

  change from baseline to 3 and 6 months

• Multiple Sclerosis Neuropsychological Screening Questionnaire - Patient Version (MSNQ; Benedict et al., 2003)

  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.

  change from baseline to 3 and 6 months

• 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.

  change from baseline to 3 and 6 months

• Wechsler Adult Intelligence Scale (WAIS-IV) Coding Subtest (Wechsler, 2008)

  A measure of processing speed. Higher scores represent better outcomes. Scores range from 0-155.

  change from baseline to 3 and 6 months

• Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983)

  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.

  change from baseline to 3 and 6 months

• Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985)

  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.

  change from baseline to 3 and 6 months

• World Health Organization Disability Assessment Scale (WHODAS 2.0)

  Self-report measure of quality of life and global functioning. Higher scores represent worse outcomes. Total score ranges from 0-144.

  change from baseline to 3 and 6 months

• Quality of Life in Neurological Disorders (Neuro-QOL): Cognitive, Ability to Participate in Social Roles and Activities, and Sleep Scales

  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.

  change from baseline to 3 and 6 months

• Memory Compensation Questionnaire (MCQ; de Frias & Dixon, 2005)

  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.

  change from baseline to 3 and 6 months

• Portland Cognitive Strategies Scale 2.0 (PCSS)

  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.

  change from baseline to 3 and 6 months

• Wechsler Adult Intelligence Scale (WAIS-IV) Digit Span Subtest (Wechsler, 2008)

  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.

  change from baseline to 3 and 6 months

Secondary Outcomes (2)

• PTSD Checklist (PCL-5; Weathers et al., 2013)

  change from baseline to 3 and 6 months

• Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999)

  change from baseline to 3 and 6 months

Study Arms (2)

Compensatory Cognitive Training (CCT)

EXPERIMENTAL

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)

Treatment as Usual (TAU)

ACTIVE COMPARATOR

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)

Interventions

Compensatory Cognitive Training (CCT) BEHAVIORAL

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).

Also known as: CCT

Compensatory Cognitive Training (CCT)

Treatment as Usual (TAU) BEHAVIORAL

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).

Also known as: TAU

Treatment as Usual (TAU)

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• VA Office of Research and Development: lead

Study Sites (1)

VA Portland Health Care System, Portland, OR

Portland, Oregon, 97207-2964, United States

Location

MeSH Terms

Conditions

Stress Disorders, Post-Traumatic

Interventions

Therapeutics

Condition Hierarchy (Ancestors)

Stress Disorders, Traumatic; Trauma and Stressor Related Disorders; Mental Disorders

Limitations and Caveats

Coronavirus disease shutdown resulted in less recruitment than initially anticipated. Groups and assessments were moved to a remote, phone-based format which may have limited understanding and application of skills taught in groups. Exclusion criteria included some diagnoses (i.e., history of TBI) which are frequently comorbid with PTSD, which limited the sample and affected recruitment efforts. Low demographic variability limits representation and generalizability to the larger population.

Results Point of Contact

• Title: Dr. Maya E. O'Neil, Principal Investigator
• Organization: VA Portland Health Care System

Maya.Oneil@va.gov

503-220-8262

Study Officials

• Maya Elin O'Neil, PhD MS

  VA Portland Health Care System, Portland, OR

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Assessors will be masked to participant condition.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: FED
• Responsible Party: SPONSOR

Model Details: This is a parallel randomized controlled pilot trial.

Study Record Dates

• First Submitted: October 3, 2018
• First Posted: October 4, 2018
• Study Start: March 6, 2019
• Primary Completion: September 29, 2024
• Study Completion: December 29, 2025
• Last Updated: January 23, 2026
• Results First Posted: October 15, 2025

Record last verified: 2026-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)