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Posttraumatic Stress DisorderCCTPTSDNCT03696225

Assessment and Treatment of Cognitive Functioning Deficits in Veterans With PTSD

A study testing Compensatory Cognitive Training (CCT) and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Posttraumatic Stress Disorder
What is being tested?
Compensatory Cognitive Training (CCT) and Treatment as Usual (TAU)
Could I receive a placebo?
No, everyone receives an active treatment
How many people
21 participants
Where
1 siteUnited States
Study dates
6 Mar 2019to 29 Dec 2025
Phase
Interventional
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United States1 site
  • VA Portland Health Care System, Portland, OR

    Portland, Oregon, 97207-2964

Other trials in United States

About this study

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.

Read the 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.

Being tested
Compensatory Cognitive Training (CCT), Treatment as Usual (TAU)
Keywords
PTSD, Cognitive Function
Medical subject headings
Stress Disorders, Post-Traumatic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Compensatory Cognitive Training (CCT)Behavioural

    Also called 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).

  • Treatment as Usual (TAU)Behavioural

    Also called 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 groups in NCT03696225
Study groupRoleWhat they receive
Compensatory Cognitive Training (CCT)ExperimentalCompensatory 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).
Receives: Behavioral: Compensatory Cognitive Training (CCT)
Treatment as Usual (TAU)Active comparatorAll 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).
Receives: Behavioral: Treatment as Usual (TAU)

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: change from baseline to 3 and 6 months

  2. 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.

    Measured: change from baseline to 3 and 6 months

  3. 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.

    Measured: change from baseline to 3 and 6 months

  4. 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.

    Measured: change from baseline to 3 and 6 months

  5. 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.

    Measured: change from baseline to 3 and 6 months

  6. 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.

    Measured: change from baseline to 3 and 6 months

  7. 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.

    Measured: change from baseline to 3 and 6 months

  8. 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.

    Measured: change from baseline to 3 and 6 months

  9. 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.

    Measured: change from baseline to 3 and 6 months

  10. 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.

    Measured: change from baseline to 3 and 6 months

  11. 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.

    Measured: change from baseline to 3 and 6 months

Secondary outcomes (2)
  1. PTSD Checklist (PCL-5; Weathers et al., 2013)

    PTSD symptoms and severity. Higher scores indicates more severe symptomology. Total score ranges from 0-80.

    Measured: change from baseline to 3 and 6 months

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

    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.

    Measured: change from baseline to 3 and 6 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted4 Oct 2018
  2. Study start6 Mar 2019
  3. Primary completion29 Sep 2024
  4. Study completion29 Dec 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
This is a parallel randomized controlled pilot trial.
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
21 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03696225
Sponsor's protocol ID
D2762-W
Other IDs
1IK2RX002762-01A1
Acronym
CCTPTSD
Status last verified
Jan 2026
First submitted
3 Oct 2018
Last updated
23 Jan 2026
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A study testing Compensatory Cognitive Training (CCT) and Treatment as Usual (TAU) in people with Posttraumatic Stress Disorder, run by VA Office of Research and Development at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 23 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 15 Oct 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Prospective-Retrospective Memory Questionnaire (PRMQ; Crawford et al., 2006) (time frame: change from baseline to 3 and 6 months). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Jan 2026.

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