Trial Outcomes & Findings for Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention (NCT NCT03373240)
NCT ID: NCT03373240
Last Updated: 2021-01-08
Results Overview
Improved functioning on cognitive-affective battery: Examining Stop Signal reaction time changed across the 4-week training period. A change score was calculated. A negative number indicates better inhibition over time.
COMPLETED
NA
46 participants
Training visit 1 through 4 weeks of training
2021-01-08
Participant Flow
Participant milestones
| Measure |
TAU Plus Cognitive Remediation Program
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Overall Study
STARTED
|
22
|
24
|
|
Overall Study
4-week Post Treatment
|
14
|
23
|
|
Overall Study
COMPLETED
|
11
|
20
|
|
Overall Study
NOT COMPLETED
|
11
|
4
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
Baseline characteristics by cohort
| Measure |
TAU Plus Cognitive Remediation Program
n=22 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=24 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
Total
n=46 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
22 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
46 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
34.9 years
STANDARD_DEVIATION 8.1 • n=99 Participants
|
32.4 years
STANDARD_DEVIATION 8.6 • n=107 Participants
|
33.6 years
STANDARD_DEVIATION 8.4 • n=206 Participants
|
|
Sex: Female, Male
Female
|
11 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
22 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=99 Participants
|
5 Participants
n=107 Participants
|
12 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
15 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
34 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=99 Participants
|
6 Participants
n=107 Participants
|
11 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
12 Participants
n=99 Participants
|
17 Participants
n=107 Participants
|
29 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
22 participants
n=99 Participants
|
24 participants
n=107 Participants
|
46 participants
n=206 Participants
|
PRIMARY outcome
Timeframe: Training visit 1 through 4 weeks of trainingPopulation: All participants who completed one or more sessions of the computerized Stop Signal task. Negative change reflects improved inhibition over time.
Improved functioning on cognitive-affective battery: Examining Stop Signal reaction time changed across the 4-week training period. A change score was calculated. A negative number indicates better inhibition over time.
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=21 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Stop Signal Reaction Time
|
-8.62 ms
Standard Error 2.79
|
—
|
PRIMARY outcome
Timeframe: 4 weeks before First Training Session through the 4-week training periodPopulation: All participants who completed the pre- and post-treatment substance use calendar.
The cube root of the number of days the participant endorsed using their primary substance. The number of days was submitted to a cube root transformation given skewness and a change score was calculated (post minus pre). A negative number indicated decreased substance use over time.
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=15 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=19 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change From Pre-Post in Substance Use
|
-.34 cube root (number of days)
Standard Error .19
|
.19 cube root (number of days)
Standard Error .17
|
PRIMARY outcome
Timeframe: from the week prior to training to the week after trainingPopulation: All participants who completed the UPPS-NU for both pre- and post-treatment cognitive-affective battery
Negative urgency (NU) subscale. The scale score range is 11-44. Higher values indicate stronger agreement with this pathway toward impulsivity. A change score was calculated. A negative number indicates less agreement with negative urgency.
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=15 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=23 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Pre-Post Cognitive Affective Battery- Negative Urgency Subscale (Part of the Urgency, Premeditation (Lack of), Perseverance (Lack of), Sensation Seeking, Positive Urgency, Impulsive Behavior Scale)
|
-3.13 score on scale
Standard Error 1.57
|
-.70 score on scale
Standard Error 1.27
|
PRIMARY outcome
Timeframe: Training visit 1 through 4 weeks of trainingPopulation: All participants who completed one or more sessions of the Lottery Task. Negative change indicated improved decision-making
The percent of risky choices per session. This would indicate that the participant selected the lottery option that reflected a riskier bet. A change score was calculated. A negative number indicates improved decision-making (selecting fewer risky options).
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=20 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task
|
-1.62 percent of risky choices
Standard Error 0.77
|
—
|
PRIMARY outcome
Timeframe: Training visit 1 through 4 weeks of trainingPopulation: All participants who completed one or more sessions of the computerized Lottery task. Negative change reflects improved decision-making.
Percent of choices the participant made that reflected selecting the ambiguous option. A change score was calculated. A negative number reflects improved decision-making (selecting more safe options).
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=20 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task
|
-1.77 percent of ambiguous choices
Standard Error .82
|
—
|
PRIMARY outcome
Timeframe: from the week prior to training (pre) to the week after training (post)Population: All participants who completed one or more sessions of the computerized PASAT. Positive change reflects improved cognitive-affective functioning (distress tolerance) over time.
Estimated change in percentage of trial attempts on round 3 of the PASAT. A positive number reflects more trial attempts in the third round of PASAT.
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=21 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT)
|
4.26 percentage of trials attempted
Standard Error .57
|
—
|
PRIMARY outcome
Timeframe: from the week prior to training (pre) to the week after training (post)Population: All participants who completed the digit backwards for both pre- and post-treatment cognitive-affective battery
Score on digit backwards. Fourteen strings of varying lengths (2 to 7 digits) are presented. A participant receives a point for each string they correctly repeat backwards. Range 0-14 points. Change score was calculated-positive values indicate improved working memory over time.
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=13 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=19 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Pre-Post Cognitive Affective Battery: Digit Backwards
|
2.08 scores on scale
Standard Error .62
|
-.21 scores on scale
Standard Error .51
|
PRIMARY outcome
Timeframe: from the week prior to training (pre) to the week after training (post)Population: All participants who completed the breath holding task for both pre- and post-treatment cognitive-affective battery
Negative emotionality-distress tolerance as measured by the difference between when the participant says they are uncomfortable and when they let go of holding their breath. Measured in seconds (this was natural log-transformed due to skewness for analyses). Positive change indicates improved distress tolerance over time.
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=15 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=23 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Pre-Post Cognitive Affective Battery: Breath Holding
|
.19 ln(seconds)
Standard Error .15
|
-.16 ln(seconds)
Standard Error .12
|
PRIMARY outcome
Timeframe: from the week prior to training (pre) to the week after training (post)Population: All participants who completed the perceived stress scale (PSS) for both pre- and post-treatment cognitive-affective battery
Negative emotionality-perceived stress. The total score ranges from 0-4. Higher scores indicate a higher level of perceived stress. A change score was calculated. Negative change indicates an improvement (reduction in perceived stress) over time.
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=15 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=23 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale
|
-.53 scores on scale
Standard Error 1.38
|
-1.61 scores on scale
Standard Error 1.11
|
PRIMARY outcome
Timeframe: from the week prior to training (pre) to the week after training (post)Population: All participants who completed the delay discounting task for both pre- and post-treatment cognitive-affective battery
Incentive salience- delay discounting. Five-Trial Adjusting-Delay Discounting Task (Koffarnus \& Bickel, 2014) is a 5-item behavioral assessment used to estimate the extent to which individuals prefer smaller immediate rewards over larger delayed rewards. A discount rate (ln (k)) is calculated for each time the measure is used. Discount rates for the 5- trial delay task were calculated by taking the inverse of the obtained Effective Delay 50 value, which is equivalent to the value of k, when fitted to this singular point. Ln(k) is the natural log of the discount rate. A change score was calculated. Negative change indicates improved decision-making
Outcome measures
| Measure |
TAU Plus Cognitive Remediation Program
n=15 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=23 Participants
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Change in Pre-Post Cognitive Affective Battery: Delay Discounting
|
-.23 ln(k)
Standard Error .52
|
-.76 ln(k)
Standard Error .42
|
Adverse Events
TAU Plus Cognitive Remediation Program
TAU Plus Control Tasks
Serious adverse events
| Measure |
TAU Plus Cognitive Remediation Program
n=22 participants at risk
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on learning and decision making.
TAU plus Cognitive Remediation Program: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS computerized games that focus on cognitive-affective self-regulatory processes.
|
TAU Plus Control Tasks
n=24 participants at risk
Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
TAU plus Control Tasks: Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.
|
|---|---|---|
|
Psychiatric disorders
Hospitalization
|
0.00%
0/22 • 2 months
|
4.2%
1/24 • Number of events 1 • 2 months
|
|
Gastrointestinal disorders
Hospitalization
|
4.5%
1/22 • Number of events 1 • 2 months
|
0.00%
0/24 • 2 months
|
|
Infections and infestations
Hospitalization
|
4.5%
1/22 • Number of events 1 • 2 months
|
0.00%
0/24 • 2 months
|
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place