N/A
N=46
Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
Drug Use Disorders
Bottom Line
View on ClinicalTrials.gov: NCT03373240 ↗Enrolled (actual)
46
Serious AEs
6.5%
Results posted
Jan 2021
Primary outcome: Primary: Change in Stop Signal Reaction Time — -8.62 ms — p=.003
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- TAU plus Cognitive Remediation Program (Behavioral); TAU plus Control Tasks (Behavioral)
- Age
- Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Oct 2019
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change in Stop Signal Reaction Time |
-8.62 | .003 sig |
| PRIMARY Change From Pre-Post in Substance Use |
-.34; .19 | .049 sig |
| PRIMARY 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; -.70 | .236 |
| PRIMARY Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task |
-1.62 | .039 sig |
| PRIMARY Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task |
-1.77 | .035 sig |
| PRIMARY Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT) |
4.26 | <.001 sig |
| PRIMARY Change in Pre-Post Cognitive Affective Battery: Digit Backwards |
2.08; -.21 | .008 sig |
| PRIMARY Change in Pre-Post Cognitive Affective Battery: Breath Holding |
.19; -.16 | .077 |
| PRIMARY Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale |
-.53; -1.61 | .547 |
| PRIMARY Change in Pre-Post Cognitive Affective Battery: Delay Discounting |
-.23; -.76 | .436 |
Summary
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.
Eligibility Criteria
Inclusion Criteria
- Meet current DSM-5 criteria for an alcohol, stimulant, cannabis, or opioid use disorder.
- Are sufficiently stable for 4 weeks of outpatient treatment.
- Are willing to provide locator information.
- Are fluent in English and have a 4th grader or higher reading level
Exclusion Criteria
- Meet DSM-5 criteria for a bipolar or schizophrenic disorder.
- Who have a legal case pending such that incarceration during the 4-week protocol is likely.
- Are physically dependent on alcohol, opioids or benzodiazepines or who report recent PCP use.
- Have a baseline Shipley estimated IQ less than 70
- Have 3 or more head injuries with loss of consciousness for over 30 minutes or lasting effects
- Have a history of chronic illness or neurological disorders (e.g., epilepsy or stroke) that would complicate evaluation of effects of cognitive training
Data sourced from ClinicalTrials.gov (NCT03373240). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.