NCT03373240

Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

Completed NA Results posted Last updated 8 January 2021

What this trial tests

NA trial testing TAU plus Cognitive Remediation Program in Drug Use Disorders in 46 participants. Completed in 17 October 2019.

Timeline

22 January 2018

Primary endpoint
17 October 2019

17 October 2019

Quick facts

Lead sponsor	Yale University
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	randomized
Design	parallel
Masking	none
Primary purpose	treatment
Enrollment	46
Start date	22 January 2018
Primary completion	17 October 2019
Estimated completion	17 October 2019
Sites	1 location across United States

Drugs / interventions tested

• TAU plus Cognitive Remediation Program
• TAU plus Control Tasks

Conditions studied

• Drug Use Disorders — all drugs for Drug Use Disorders →

Sponsor

Yale University

Who can join

Adults 18 to 50, any sex, with Drug Use Disorders. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Change in Stop Signal Reaction Time Primary · Training visit 1 through 4 weeks of training

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.

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	-8.62	± 2.79

Change From Pre-Post in Substance Use Primary · 4 weeks before First Training Session through the 4-week training period

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.

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	-.34	± .19
TAU Plus Control Tasks	.19	± .17

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) Primary · from the week prior to training to the week after training

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.

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	-3.13	± 1.57
TAU Plus Control Tasks	-.70	± 1.27

Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task Primary · Training visit 1 through 4 weeks of training

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).

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	-1.62	± 0.77

Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task Primary · Training visit 1 through 4 weeks of training

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).

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	-1.77	± .82

Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT) Primary · from the week prior to training (pre) to the week after training (post)

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.

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	4.26	± .57

Change in Pre-Post Cognitive Affective Battery: Digit Backwards Primary · from the week prior to training (pre) to the week after training (post)

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.

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	2.08	± .62
TAU Plus Control Tasks	-.21	± .51

Change in Pre-Post Cognitive Affective Battery: Breath Holding Primary · from the week prior to training (pre) to the week after training (post)

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.

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	.19	± .15
TAU Plus Control Tasks	-.16	± .12

Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale Primary · from the week prior to training (pre) to the week after training (post)

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.

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	-.53	± 1.38
TAU Plus Control Tasks	-1.61	± 1.11

Change in Pre-Post Cognitive Affective Battery: Delay Discounting Primary · from the week prior to training (pre) to the week after training (post)

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 calcul

Group	Value	95% CI
TAU Plus Cognitive Remediation Program	-.23	± .52
TAU Plus Control Tasks	-.76	± .42

Adverse events — posted to ClinicalTrials.gov

Time frame: 2 months. Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

TAU Plus Cognitive Remediation Program

Serious: 2/22 (9%)

Deaths: 0/22

TAU Plus Control Tasks

Serious: 1/24 (4%)

Deaths: 0/24

Serious adverse events (3 terms)

Reaction	System	TAU Plus Cognitive Remedia…	TAU Plus Control Tasks
Hospitalization	Psychiatric disorders	—	—
Hospitalization	Gastrointestinal disorders	—	—
Hospitalization	Infections and infestations	—	—

Most-reported serious reactions: Hospitalization, Hospitalization, Hospitalization.

Data from ClinicalTrials.gov NCT03373240 adverse events section.

Sponsor's own description

We are proposing a small randomized clinical trial in which 100 substance users will complete the existing Psychotherapy Development Center (PDC) pretreatment assessment battery as well as a novel battery of assays to evaluate cognitive-affective functioning. After completing pretreatment assessments, participants will be randomized to either a (1) cognitive remediation program (training tasks) specifically designed to address cognitive-affective dysregulation or (2) control tasks (verbal fluency tasks). Tasks will be completed twice per week for 4 weeks, after which assessment batteries will be repeated. Finally, we will evaluate real-world behavior and the durability of the training via a one-month follow-up, which will include assessment of substance use as well as the cognitive-affective battery.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.