Alcohol Use Disorder Clinical Trial
Official title:
Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder
Verified date | January 2021 |
Source | VA Office of Research and Development |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 90 |
Est. completion date | July 21, 2019 |
Est. primary completion date | July 21, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 65 Years |
Eligibility | 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. |
Country | Name | City | State |
---|---|---|---|
United States | VA Palo Alto Health Care System, Palo Alto, CA | Palo Alto | California |
Lead Sponsor | Collaborator |
---|---|
VA Office of Research and Development |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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. | 6-weeks | |
Primary | 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. | 6-weeks | |
Primary | 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. | 6-weeks | |
Primary | 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. | 6-weeks | |
Primary | 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. | 6-weeks | |
Primary | 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. | 6-weeks | |
Primary | 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. | 6-weeks | |
Primary | 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. | 6-weeks | |
Secondary | 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. | 6-weeks | |
Secondary | 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. | 6-weeks |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04788004 -
Long-term Recovery: Longitudinal Study of Neuro-behavioral Markers of Recovery and Precipitants of Relapse
|
||
Recruiting |
NCT05684094 -
Mechanisms of Risky Alcohol Use in Young Adults: Linking Sleep to Reward- and Stress-Related Brain Function
|
N/A | |
Completed |
NCT03406039 -
Testing the Efficacy of an Online Integrated Treatment for Comorbid Alcohol Misuse and Emotional Problems
|
N/A | |
Completed |
NCT03573167 -
Mobile Phone-Based Motivational Interviewing in Kenya
|
N/A | |
Completed |
NCT04817410 -
ED Initiated Oral Naltrexone for AUD
|
Phase 1 | |
Active, not recruiting |
NCT04267692 -
Harm Reduction Talking Circles for American Indians and Alaska Natives With Alcohol Use Disorders
|
N/A | |
Completed |
NCT03872128 -
The Role of Neuroactive Steroids in Stress, Alcohol Craving and Alcohol Use in Alcohol Use Disorders
|
Phase 1 | |
Completed |
NCT02989662 -
INIA Stress and Chronic Alcohol Interactions: Glucocorticoid Antagonists in Heavy Drinkers
|
Phase 1/Phase 2 | |
Recruiting |
NCT06030154 -
Amplification of Positivity for Alcohol Use
|
N/A | |
Active, not recruiting |
NCT05419128 -
Family-focused vs. Drinker-focused Smartphone Interventions to Reduce Drinking-related Consequences of COVID-19
|
N/A | |
Completed |
NCT04564807 -
Testing an Online Insomnia Intervention
|
N/A | |
Completed |
NCT04284813 -
Families With Substance Use and Psychosis: A Pilot Study
|
N/A | |
Completed |
NCT04203966 -
Mental Health and Well-being of People Who Seek Help From Their Member of Parliament
|
||
Recruiting |
NCT05861843 -
Craving Assessment in Patients With Alcohol Use Disorder Using Virtual Reality Exposure
|
||
Terminated |
NCT04404712 -
FAAH Availability in Psychiatric Disorders: A PET Study
|
Early Phase 1 | |
Enrolling by invitation |
NCT04128761 -
Decreasing the Temporal Window in Individuals With Alcohol Use Disorder
|
N/A | |
Not yet recruiting |
NCT06337721 -
Preventing Alcohol Use Disorders and Alcohol-Related Harms in Pacific Islander Young Adults
|
N/A | |
Not yet recruiting |
NCT06163651 -
Evaluating a One-Year Version of the Parent-Child Assistance Program
|
N/A | |
Not yet recruiting |
NCT06444243 -
Psilocybin-assisted Therapy for Alcohol Use Disorder
|
Phase 2 | |
Enrolling by invitation |
NCT02544581 -
Preliminary Analysis of the Soberlink Alcohol Breath Analyzer System's (SABA) Clinical Utility During Aftercare
|
N/A |