Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder

NCT ID: NCT02929979

Last Updated: 2021-02-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-01-01
• Study Completion Date: 2019-07-21

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.

Conditions

Alcohol Use Disorder; PTSD; Cognitive Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: FACTORIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Cognitive Training

Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ. BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations. The investigators will use a suite of BrainHQ exercises designed to target and ameliorate cognitive disruptions in 4 cognitive domains (see main outcome). The investigators will employ basic exercises that focus on increasing processing efficiency in the auditory and visual perceptual and working memory domains, as well as exercises that target impulsivity and cognitive biases. Exercises will be packaged into 4 modules (attention skills, memory skills, executive functioning skills, cognitive control skills) comprised of 4 exercises each. All participants will progress through the same fixed schedule of modules.

Group Type: EXPERIMENTAL

Cognitive Training

Intervention Type: BEHAVIORAL

Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ (BPI/Posit Science, San Francisco). BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations. The investigators will use a suite of BrainHQ exercises designed to target and ameliorate cognitive disruptions in 4 cognitive domains (see main outcome). The investigators will employ basic exercises that focus on increasing processing efficiency in the auditory and visual perceptual and working memory domains, as well as exercises that target impulsivity and cognitive biases. Exercises will be packaged into 4 modules (attention skills, memory skills, executive functioning skills, cognitive control skills) comprised of 4 exercises each. All participants will progress through the same fixed schedule of modules.

Placebo control

Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. The investigators selected this control activity because it mirrors the game-like properties of the cognitive training and it will be used to control for contact with research personnel and for the non-specific effects of participant motivation and engagement with daily computerized activities. It also allows for a double blind study design. Games from the website Sporcle will be used and an online account can be created for each participant.

Group Type: PLACEBO_COMPARATOR

Cognitive training placebo control

Intervention Type: BEHAVIORAL

Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. The investigators selected this control activity because it mirrors the game-like properties of the cognitive training and it will be used to control for contact with research personnel and for the non-specific effects of participant motivation and engagement with daily computerized activities. It also allows for a double blind study design. Games from the website Sporcle will be used and an online account can be created for each participant.

Interventions

Cognitive Training

Participants will complete 22.5 hours of cognitive training exercises over 6-weeks (training 5 times a week) using an app-based program, BrainHQ (BPI/Posit Science, San Francisco). BrainHQ is based on a previous neuroscience-based cognitive training program shown to improve cognition in several different randomized controlled studies with other clinical populations. The investigators will use a suite of BrainHQ exercises designed to target and ameliorate cognitive disruptions in 4 cognitive domains (see main outcome). The investigators will employ basic exercises that focus on increasing processing efficiency in the auditory and visual perceptual and working memory domains, as well as exercises that target impulsivity and cognitive biases. Exercises will be packaged into 4 modules (attention skills, memory skills, executive functioning skills, cognitive control skills) comprised of 4 exercises each. All participants will progress through the same fixed schedule of modules.

Intervention Type: BEHAVIORAL

Cognitive training placebo control

Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. The investigators selected this control activity because it mirrors the game-like properties of the cognitive training and it will be used to control for contact with research personnel and for the non-specific effects of participant motivation and engagement with daily computerized activities. It also allows for a double blind study design. Games from the website Sporcle will be used and an online account can be created for each participant.

Intervention Type: BEHAVIORAL

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

VA Office of Research and Development

FED

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Adrienne Julie Heinz, PhD

Role: PRINCIPAL_INVESTIGATOR

VA Palo Alto Health Care System, Palo Alto, CA

Locations

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan: cover page

View Document

Related Links

http://www.sporcle.com

Sporcle Website

https://idp.springer.com/authorize/casa?redirect_uri=https://link.springer.com/content/pdf/10.1007/s11065-009-9083-4.pdf&casa_token=leCw-mNAgLIAAAAA:8srfkEu1hKO2QF2wJPOvXb2bmZrTBh2VWQN_8AtdKA8z7v2LKW1TlNz_SZcUYySBCeZLSrkr2Tnw7Ti8Hg

The Iowa Gambling Task

Other Identifiers

1IK2RX001492-01A1

Identifier Type: NIH

Identifier Source: secondary_id

View Link

D1492-W

Identifier Type: -

Identifier Source: org_study_id