Trial Outcomes & Findings for Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder (NCT NCT02929979)

Results Overview

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.

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

90 participants

Primary outcome timeframe

6-weeks

Results posted on

2021-02-11

Participant Flow

Participant milestones

Participant milestones
Measure	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.	Placebo Control Participants will play a rotating set of commercial computer games at the same dose and frequency as the cognitive training. Games from the website Sporcle were used for each participant.
Overall Study STARTED	52	38
Overall Study COMPLETED	25	28
Overall Study NOT COMPLETED	27	10

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Cognitive Remediation for Alcohol Use Disorder and Posttraumatic Stress Disorder

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Cognitive Training n=52 Participants 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.	Placebo Control n=38 Participants 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.	Total n=90 Participants Total of all reporting groups
Age, Continuous	40.41 years STANDARD_DEVIATION 11.43 • n=5 Participants	40.41 years STANDARD_DEVIATION 11.43 • n=7 Participants	40.41 years STANDARD_DEVIATION 11.43 • n=5 Participants
Sex: Female, Male Female	4 Participants n=5 Participants	3 Participants n=7 Participants	7 Participants n=5 Participants
Sex: Female, Male Male	48 Participants n=5 Participants	35 Participants n=7 Participants	83 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	9 Participants n=5 Participants	6 Participants n=7 Participants	15 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	43 Participants n=5 Participants	32 Participants n=7 Participants	75 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Posttraumatic Stress Disorder	52 Participants n=5 Participants	38 Participants n=7 Participants	90 Participants n=5 Participants

PRIMARY outcome

Timeframe: 6-weeks

Population: t-test; data were missing for some participants due to attrition

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=21 Participants 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.	Placebo Control n=22 Participants 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 wi
The Revised Hopkins Verbal Learning Test	47.71 units on a scale Standard Deviation 10.34	44.14 units on a scale Standard Deviation 10.70

PRIMARY outcome

Timeframe: 6-weeks

Population: t-test; some data were missing due to attrition

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=21 Participants 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.	Placebo Control n=22 Participants 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 wi
The Wechsler Adult Intelligence Scale-IV Working Memory Index	102 units on a scale Standard Deviation 14.34	103.27 units on a scale Standard Deviation 13.99

PRIMARY outcome

Timeframe: 6-weeks

Population: t-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=26 Participants 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.	Placebo Control n=28 Participants 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 wi
The Conners' Continuous Performance Task II	47.92 units on a scale Standard Deviation 10.59	50.11 units on a scale Standard Deviation 8.44

PRIMARY outcome

Timeframe: 6-weeks

Population: t-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=21 Participants 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.	Placebo Control n=22 Participants 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 wi
The Color-Word Interference Test (DKEFS)	10.86 units on a scale Standard Deviation 2.37	10.55 units on a scale Standard Deviation 2.20

PRIMARY outcome

Timeframe: 6-weeks

Population: t-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=26 Participants 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.	Placebo Control n=28 Participants 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 wi
The Iowa Gambling Task	760.65 Dollars Standard Deviation 1547.92	-371.40 Dollars Standard Deviation 1929.80

PRIMARY outcome

Timeframe: 6-weeks

Population: T-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=26 Participants 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.	Placebo Control n=28 Participants 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 wi
Trail Making Test (TMT) - Part B	51.00 units on a scale Standard Deviation 12.71	49.93 units on a scale Standard Deviation 11.71

PRIMARY outcome

Timeframe: 6-weeks

Population: t-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=26 Participants 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.	Placebo Control n=28 Participants 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 wi
The Wisconsin Card Sorting Test - Computer Version 4 Research Edition	48.65 units on a scale Standard Deviation 14.25	51.38 units on a scale Standard Deviation 7.28

PRIMARY outcome

Timeframe: 6-weeks

Population: t-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=26 Participants 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.	Placebo Control n=28 Participants 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 wi
The Tower Test (DKEFS)	11.83 units on a scale Standard Deviation 1.97	11.00 units on a scale Standard Deviation 2.00

SECONDARY outcome

Timeframe: 6-weeks

Population: t-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=26 Participants 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.	Placebo Control n=28 Participants 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 wi
Functional Status - Inventory of Psychosocial Functioning	40.41 units on a scale Standard Deviation 13.53	40.94 units on a scale Standard Deviation 11.12

SECONDARY outcome

Timeframe: 6-weeks

Population: t-test; missing data for some participants due to attrition or technical difficulties in test administration

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.

Outcome measures

Outcome measures
Measure	Cognitive Training n=26 Participants 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.	Placebo Control n=28 Participants 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 wi
PTSD Symptom Severity	36.04 units on a scale Standard Deviation 16.15	40.64 units on a scale Standard Deviation 19.59

Adverse Events

Cognitive Training

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Placebo Control

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Adrienne Heinz

VA Palo Alto Healthcare System

Phone: 9196306847

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place