Alcohol Use DisorderNCT02929979
Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder
A study testing Cognitive Training in people with Alcohol Use Disorder and PTSD, run by VA Office of Research and Development at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Alcohol Use Disorder, PTSD, Cognitive Dysfunction
- What is being tested?
- Cognitive Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Jan 2015to 21 Jul 2019
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Show all 12Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
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.
Read the 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
- Being tested
- Cognitive Training, Cognitive training placebo control
- Keywords
- PTSD, Alcohol Use Disorder, Cognitive Training, Veterans
- Medical subject headings
- Alcoholism, Stress Disorders, Post-Traumatic, Cognitive Dysfunction
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cognitive TrainingBehavioural
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.
Cognitive training placebo controlBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| Cognitive Training | Experimental | 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. Receives: Behavioral: Cognitive Training |
| Placebo control | Placebo comparator | 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. Receives: Behavioral: Cognitive training placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Revised Hopkins Verbal Learning Test
The Revised Hopkins Verbal Learning Test (HVLT-R; Brandt \& Benedict, 2001) assesses learning and memory for a 12-word list (organized into three semantic categories) immediately after the list is read (trial 1), cumulatively across trials (sum trials 1-3) and after a delay (free recall after 25 minutes). Test scores were normalized to t-scores with a Test mean = 50; SD =10 and higher scores indicate better verbal learning and memory.
Measured: 6-weeks
The Wechsler Adult Intelligence Scale-IV Working Memory Index
The Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008) Working Memory Index subtests will be employed: (1) Digit Span - participants are asked to repeat a number sequence, repeat in reverse order and then repeat in a sequential order; (2) Arithmetic - participants are asked to mentally solve arithmetic word problems within a time limit; (3) Letter-Number Sequencing - participants are asked to recall a combination of numbers and letters that they must first numerically and alphabetically sequence. Test scores are standardized on a normed scale with a Test mean = 100; SD =15 and higher scores indicate better working memory.
Measured: 6-weeks
The Conners' Continuous Performance Task II
The Conners' Continuous Performance Task II (CPT-II; Conners \& Staff, 2000) is a computerized task that assesses vigilance and sustained attention. The participant is presented with a stimulus at variable interstimulus event rates and is asked to respond to all stimuli except the "X." Thus they must maintain a continuous response set (sustained attention) and inhibit responding when a specific target is presented. Test scores are normed on a t-score with a Test mean = 50; SD =10; higher scores indicate better response inhibition.
Measured: 6-weeks
The Color-Word Interference Test (DKEFS)
The Color-Word Interference Test is included in the DKEFS tests (DKEFS; Delis, Kaplan, \& Kramer, 2001) and is a variant of the Stroop procedure. Participants are asked to name the ink color (e.g., blue) in which different color words (e.g., red) are printed and thus the test captures ability to inhibit an overlearned response. Test scores are normed on a standardized scale with a Test mean = 10; SD = 3; higher scores indicate better response inhibition.
Measured: 6-weeks
The Iowa Gambling Task
The Iowa Gambling Task (IGT; Bechara et al., 1994) is computerized and participants select from among 4 decks of cards that vary in monetary reward and punishment (i.e., risky "bad" decks that result in infrequent but large losses and "good" decks that result in gradual monetary gain over repeated trials). The IGT will be used to assess decision-making. Money earned is the primary outcome with more money earned indicated better decision making. Go to the links in the Reference section to learn more about this outcome measure.
Measured: 6-weeks
Trail Making Test (TMT) - Part B
On TMT Part B (Reitan, 1955) participants are asked to connect consecutively numbered and lettered circles, alternating between letters and numbers, as quickly as possible (speeded set-shifting). Test scores were normalized to a t-score with a mean = 50; SD =10; with higher scores indicating better set-shifting abilities.
Measured: 6-weeks
The Wisconsin Card Sorting Test - Computer Version 4 Research Edition
The Wisconsin Card Sorting Test - computer version 4 Research Edition (WCST; Heaton et al., 1993) uses stimulus cards to assess set-shifting, an index of cognitive flexibility. Participants must match a stimulus card to the appropriate card deck based on shape designs and rules that shift throughout the task. Scores were normed with t-scores with a mean = 50; SD =10; and higher scores indicating more cognitive flexibility.
Measured: 6-weeks
The Tower Test (DKEFS)
The Tower Test is included in the Delis-Kaplan Executive Function System Tests (DKEFS; Delis et al., 2001) and participants are tasked with moving five disks across three pegs to construct a target tower in the fewest number of moves possible. The Tower test will be used to assess planning and procedural problem solving. Scores were normed to a standardized score with a mean = 10; SD =3; with higher scores indicating better problem solving abilities.
Measured: 6-weeks
Secondary outcomes (2)
Functional Status - Inventory of Psychosocial Functioning
The 80-item Inventory of Psychosocial Functioning (IPF; Marx et al., 2009), was developed among Veterans to assess level of functional impairment. The IPF includes 80 self-report and behavioral indices that assess current psychosocial functioning across 7 domains. Domain scores are summed to yield a total score for psychosocial functioning. The IPF yields a grand mean and seven subscale means for functioning in romantic partnerships, family, friendships, parenting, education, work, and self-care activities. Items are rated from 0 (never) to 6 (always). Each subscale is scored by summing scored items, dividing by the maximum possible score, and multiplying by 100, yielding grand and subscales means of 0-100, with higher scores indicating greater impairment. Because participants may skip subscales that do not apply (except for the self-care subscale), the sum of the IPF subscale means is divided by the number of subscales completed.
Measured: 6-weeks
PTSD Symptom Severity
The PTSD Checklist - Military Version (PCL-M; Weathers et al., 2012; National Center for PTSD) is comprised of 20 items that correspond to the 20 DSM-5 (APA, 2013) symptoms of PTSD. The PCL-M provides an index of global PTSD symptom severity and will be administered throughout the study. Scores can range from 0-80 with higher scores indicating higher levels of PTSD symptom severity.
Measured: 6-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Oct 2016 (estimated)
- Study start1 Jan 2015
- Primary completion21 Jul 2019
- Study completion21 Jul 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Alcohol Use DisorderStudies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Factorial
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Adrienne Julie Heinz, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02929979
- Sponsor's protocol ID
- D1492-W
- Other IDs
- 1IK2RX001492-01A1
- Status last verified
- Jan 2021
- First submitted
- 28 Sep 2016
- Last updated
- 11 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder
- ClinicalTrials.gov ID
- NCT02929979
- Acronym / sponsor ID
- D1492-W
- Conditions
- Alcohol Use Disorder, PTSD, Cognitive Dysfunction
- Keywords
- PTSD, Alcohol Use Disorder, Cognitive Training, Veterans
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- 1 Jan 2015 (actual)
- Primary completion
- 21 Jul 2019 (actual)
- Study completion
- 21 Jul 2019 (actual)
- First posted
- 11 Oct 2016 (estimated)
- Results
- Posted 11 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cognitive Training | Experimental | Behavioral: Cognitive TrainingParticipants 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. |
| Placebo control | Placebo comparator | Behavioral: Cognitive training placebo controlParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (12 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Cognitive TrainingParticipants 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. | Behavioural | Cognitive Training |
| Cognitive training placebo controlParticipants 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. | Behavioural | Placebo control |
Primary outcome
The Revised Hopkins Verbal Learning Test
Time frame: 6-weeks
The Revised Hopkins Verbal Learning Test (HVLT-R; Brandt \& Benedict, 2001) assesses learning and memory for a 12-word list (organized into three semantic categories) immediately after the list is read (trial 1), cumulatively across trials (sum trials 1-3) and after a delay (free recall after 25 minutes). Test scores were normalized to t-scores with a Test mean = 50; SD =10 and higher scores indicate better verbal learning and memory.
The Wechsler Adult Intelligence Scale-IV Working Memory Index
Time frame: 6-weeks
The Wechsler Adult Intelligence Scale-IV (WAIS-IV; Wechsler, 2008) Working Memory Index subtests will be employed: (1) Digit Span - participants are asked to repeat a number sequence, repeat in reverse order and then repeat in a sequential order; (2) Arithmetic - participants are asked to mentally solve arithmetic word problems within a time limit; (3) Letter-Number Sequencing - participants are asked to recall a combination of numbers and letters that they must first numerically and alphabetically sequence. Test scores are standardized on a normed scale with a Test mean = 100; SD =15 and higher scores indicate better working memory.
The Conners' Continuous Performance Task II
Time frame: 6-weeks
The Conners' Continuous Performance Task II (CPT-II; Conners \& Staff, 2000) is a computerized task that assesses vigilance and sustained attention. The participant is presented with a stimulus at variable interstimulus event rates and is asked to respond to all stimuli except the "X." Thus they must maintain a continuous response set (sustained attention) and inhibit responding when a specific target is presented. Test scores are normed on a t-score with a Test mean = 50; SD =10; higher scores indicate better response inhibition.
The Color-Word Interference Test (DKEFS)
Time frame: 6-weeks
The Color-Word Interference Test is included in the DKEFS tests (DKEFS; Delis, Kaplan, \& Kramer, 2001) and is a variant of the Stroop procedure. Participants are asked to name the ink color (e.g., blue) in which different color words (e.g., red) are printed and thus the test captures ability to inhibit an overlearned response. Test scores are normed on a standardized scale with a Test mean = 10; SD = 3; higher scores indicate better response inhibition.
The Iowa Gambling Task
Time frame: 6-weeks
The Iowa Gambling Task (IGT; Bechara et al., 1994) is computerized and participants select from among 4 decks of cards that vary in monetary reward and punishment (i.e., risky "bad" decks that result in infrequent but large losses and "good" decks that result in gradual monetary gain over repeated trials). The IGT will be used to assess decision-making. Money earned is the primary outcome with more money earned indicated better decision making. Go to the links in the Reference section to learn more about this outcome measure.
Trail Making Test (TMT) - Part B
Time frame: 6-weeks
On TMT Part B (Reitan, 1955) participants are asked to connect consecutively numbered and lettered circles, alternating between letters and numbers, as quickly as possible (speeded set-shifting). Test scores were normalized to a t-score with a mean = 50; SD =10; with higher scores indicating better set-shifting abilities.
The Wisconsin Card Sorting Test - Computer Version 4 Research Edition
Time frame: 6-weeks
The Wisconsin Card Sorting Test - computer version 4 Research Edition (WCST; Heaton et al., 1993) uses stimulus cards to assess set-shifting, an index of cognitive flexibility. Participants must match a stimulus card to the appropriate card deck based on shape designs and rules that shift throughout the task. Scores were normed with t-scores with a mean = 50; SD =10; and higher scores indicating more cognitive flexibility.
The Tower Test (DKEFS)
Time frame: 6-weeks
The Tower Test is included in the Delis-Kaplan Executive Function System Tests (DKEFS; Delis et al., 2001) and participants are tasked with moving five disks across three pegs to construct a target tower in the fewest number of moves possible. The Tower test will be used to assess planning and procedural problem solving. Scores were normed to a standardized score with a mean = 10; SD =3; with higher scores indicating better problem solving abilities.
2 secondary outcomes
Functional Status - Inventory of Psychosocial Functioning
Time frame: 6-weeks
PTSD Symptom Severity
Time frame: 6-weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Sporcle WebsiteLink provided by the sponsor.
- The Iowa Gambling TaskLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adrienne Julie Heinz, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Cognitive Training in people with Alcohol Use Disorder and PTSD, 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 4 inclusion and 12 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 11 Feb 2021. 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. Some participants in this study may receive a placebo. 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 11 Feb 2021). 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?
The Revised Hopkins Verbal Learning Test (time frame: 6-weeks). The study lists 8 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 11 Feb 2021.