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Behavioral Intervention
Cognitive Training for PTSD (CCTPTSD Trial)
N/A
Waitlist Available
Led By Maya Elin O'Neil, PhD MS
Research Sponsored by VA Office of Research and Development
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Eligible Veterans must meet DSM-5 criteria for PTSD with evidence-based PTSD treatment participation within the past 2 years
Be older than 18 years old
Must not have
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
Not currently participating in any type of brain stimulation treatment
Timeline
Screening 3 weeks
Treatment Varies
Follow Up change from baseline to 3 and 6 months
Awards & highlights
No Placebo-Only Group
Summary
This trial is testing whether an intervention called compensatory cognitive training (CCT) is effective in improving cognitive functioning in veterans with posttraumatic stress disorder (PTSD).
Who is the study for?
This trial is for English-speaking Veterans with PTSD who've had treatment in the last 2 years and still struggle with cognitive issues like memory, attention, or decision-making. They must have a mental health provider and not suffer from severe psychiatric disorders, substance dependence (recent), major brain injuries, or conditions affecting cognition.
What is being tested?
The study tests Compensatory Cognitive Training (CCT) against usual care to see if CCT can help veterans with PTSD improve their cognitive skills such as concentration and memory. It's a pilot randomized controlled trial preparing for a larger future study.
What are the potential side effects?
Since this trial involves cognitive training rather than medication, traditional side effects are not expected. However, participants may experience frustration or fatigue during training exercises.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a veteran diagnosed with PTSD and have been in treatment within the last 2 years.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have no history of severe brain injuries or diseases affecting my brain function.
Select...
I am not undergoing any brain stimulation treatments.
Select...
I do not have major hearing or vision problems.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ change from baseline to 3 and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~change from baseline to 3 and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
California Verbal Learning Test (CVLT-II; Delis et al., 2000)
Controlled Oral Word Association Test (Benton, Hamsher, & Sivan, 1983)
Halstead Reitan Trailmaking Test (Trails A & B; Reitan & Wolfson, 1985)
+7 moreSecondary study objectives
Mini International Neuropsychiatric Interview (MINI; Sheehan et al., 2006)
PTSD Checklist (PCL-5; Weathers et al., 2013)
Patient Health Questionnaire (PHQ-9; Spitzer, Kroenke, & Williams, 1999)
Awards & Highlights
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.
Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Compensatory Cognitive Training (CCT)Experimental Treatment1 Intervention
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).
Group II: Treatment as Usual (TAU)Active Control1 Intervention
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).
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Who is running the clinical trial?
VA Office of Research and DevelopmentLead Sponsor
1,664 Previous Clinical Trials
3,765,767 Total Patients Enrolled
Maya Elin O'Neil, PhD MSPrincipal InvestigatorVA Portland Health Care System, Portland, OR
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Eligibility Criteria:
This trial includes the following eligibility criteria:- I have a mental health provider or case manager for my care.I experience issues with memory, focus, or decision-making.I experience memory issues or focus problems that affect my daily activities.I have no history of severe brain injuries or diseases affecting my brain function.I am a veteran diagnosed with PTSD and have been in treatment within the last 2 years.I am not undergoing any brain stimulation treatments.I do not have major hearing or vision problems.My cognitive issues do not stop me from living independently.
Research Study Groups:
This trial has the following groups:- Group 1: Compensatory Cognitive Training (CCT)
- Group 2: Treatment as Usual (TAU)
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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