Clinical trial NCT02929979: Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder
Official title: Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Alcohol Use Disorder
PTSD
Cognitive Dysfunction
Keywords: PTSD
Alcohol Use Disorder
Cognitive Training
Veterans
Lead sponsor: VA Office of Research and Development
Sponsor class: FED
First posted: 2016-10-11
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

Brief summary: The project will examine whether a computerized neuroscience-based cognitive training program can improve cognitive functioning and recovery outcomes among Veterans with Alcohol Use Disorder and co-occurring PTSD. Information from this study will help determine the malleability of cognitive dysfunction, an established risk factor for poor recovery outcomes in this population. Improved functional outcomes can decrease risk of chronic impairment and ultimately help affected individuals live richer, more productive lives. Web-based treatment technologies may increase the reach and impact of treatment, and foster patient recovery in cases where staffing, space, acceptability of counseling, and transportation are barriers. Findings may also support expanding use of existing, highly-accessible cognitive remediation technologies to other vulnerable clinical populations.

Detailed description: The prevalence of Alcohol Use Disorder (AUD), Posttraumatic Stress Disorder (PTSD) and co-occurring AUD and PTSD is elevated among Veterans compared to civilians (Carter et al., 2011). Despite available empirically supported treatments, relapse and non-response rates remain high and individuals with co-occurring AUD and PTSD evidence particularly poor clinical and functional outcomes (McCarthy \& Petrakis, 2010). Given recent estimates that 63-76% of Operation Enduring Freedom/Operation Iraqi Freedom (OEF/OIF) Veterans with an AUD also have a diagnosis of PTSD (Seal et al., 2011), there is urgent need to reduce chronic impairment among this growing and highly vulnerable population.

AUD and PTSD are characterized by separate and overlapping deficits in attention, memory and higher-order skills known as executive functions (e.g., planning, inhibition, self-regulation), which are in turn, associated with poor clinical and functional outcomes (Bates et al., 2013; Polak et al., 2012, Aupperle, 2012). Indeed, cognitive dysfunction can interfere with many aspects of recovery (e.g. gaining control of maladaptive, over-trained behaviors) and its targeting as a trans-disease process for direct intervention represents a potentially high-yield and innovative approach for optimizing recovery outcomes. Neuroscience-based computerized cognitive training programs for psychiatric illness have achieved growing support in the literature and demonstrate strong potential to remediate disrupted cognitive processes observed in AUD and co-occurring PTSD (Bates et. 2013; Vinogradov et al., 2012). These programs offer a highly accessible, individualized, patient-driven, non-medication treatment approach for improving cognitive functioning. Such improvements may increase emotional and behavioral control and enhance patients' capacity to effectively employ more adaptive self-management strategies. To date however, no studies have capitalized on available evidence-based cognitive remediation technologies to comprehensively target patterns of neurocognitive dysfunction that underlie both AUD and PTSD.

The proposed Rehabilitation Research and Development (RR\&D) Career Development Award-2 (CDA-2) seeks to fill this gap by conducting a randomized prospective study, designed to evaluate the feasibility and efficacy of an existing web-based cognitive training program (BrainHQ; Posit Science/Brain Plasticity Institute) versus a placebo, for improving cognitive functioning and recovery outcomes. The research will be conducted iteratively, in two stages, based on the Stage Model of Behavioral Therapy Development per the National Institute on Drug Abuse, and has two overarching aims: Aim 1: Examine the acceptability, usability and feasibility of an existing web-based cognitive training program tailored for AUD and co-occurring PTSD. Aim 2: Test the efficacy of the web-based cognitive training program to improve cognitive functioning as well as clinical and functional outcomes. To test these aims, 148 Veterans with AUD and PTSD will be recruited from an outpatient Substance Use Disorder (SUD) treatment program. Participants will be randomized into either cognitive training or a computer game control. Individuals will then complete a baseline assessment, followed by 30 hours of home-based cognitive training or computer games over 6 weeks. Assessments will be completed each week of the training, as well as post-training and at post-training follow-up. The primary outcome will be performance on an (untrained) neuropsychological assessment battery 6 months post-training. Secondary outcomes include alcohol use, PTSD symptoms and quality of life.

Findings from the proposed study will inform clinical practice and policy by investigating whether a cognitive training program (shown to improve cognitive functioning in other clinical populations) can improve cognitive functioning and promote gains in functional recovery from AUD and PTSD. This study will lay the groundwork to investigate the potential for cognitive training to remediate neurocognitive disruptions in other dually diagnosed SUD patient populations across different VA treatment programs. This translational program of research will help vulnerable Veteran populations achieve more optimal and enduring recovery outcomes.

Eligibility criteria: Inclusion Criteria:

* Be a Veteran
* Meet DSM-5 diagnostic criteria for current AUD
* Meet DSM-5 criteria for current PTSD
* Be willing to perform daily home-based computer exercises for 6 weeks

Exclusion Criteria:

Individuals will be excluded based on evidence of the following:

* History of, or current, psychotic disorder or Schizophrenia
* Current scheduled (i.e., daily) prescribed use of cognitive enhancers (e.g., Memantine) or stimulants (e.g., Methylphenidate) that may enhance cognitive performance
* Current severe traumatic brain injury (DoD TBI Screen 2)
* Any type of dementia (Mini Mental Status Exam (MMSE) \< 24), delirium or medical illnesses associated with potential cognitive issues (HIV, Hypothyroidism, B-12 deficiency)
* Any level of mental retardation (Wechsler Test of Adult Reading WTAR)
* Limited ability to speak/read/write/understand English (WTAR)
* Inadequate vision or hearing
* Active suicidal/homicidal intent
* Self-report and collateral history from medical record/primary care physician/outpatient addiction treatment team will be used as necessary to determine inclusion and exclusion.

  * Suicidal and homicidal intent will be assessed in the context of a structured clinical interview.
  * In the unlikely event that respondents endorse active intent they will be referred immediately for treatment and will be excluded from the current study.

Primary outcomes:
measure: The Revised Hopkins Verbal Learning Test
timeFrame: 6-weeks
measure: The Wechsler Adult Intelligence Scale-IV Working Memory Index
timeFrame: 6-weeks
measure: The Conners' Continuous Performance Task II
timeFrame: 6-weeks
measure: The Color-Word Interference Test (DKEFS)
timeFrame: 6-weeks
measure: The Iowa Gambling Task
timeFrame: 6-weeks
measure: Trail Making Test (TMT) - Part B
timeFrame: 6-weeks
measure: The Wisconsin Card Sorting Test - Computer Version 4 Research Edition
timeFrame: 6-weeks
measure: The Tower Test (DKEFS)
timeFrame: 6-weeks
Secondary outcomes:
measure: Functional Status - Inventory of Psychosocial Functioning
timeFrame: 6-weeks
measure: PTSD Symptom Severity
timeFrame: 6-weeks
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: VA Palo Alto Health Care System, Palo Alto, CA
state: California
Study officials:
affiliation: VA Palo Alto Health Care System, Palo Alto, CA
name: Adrienne Julie Heinz, PhD
role: PRINCIPAL_INVESTIGATOR
References: