Clinical trial NCT03373240: Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
Official title: Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Drug Use Disorders
Keywords: Drug use Disorders
Cognitive Remediation
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute on Drug Abuse (NIDA)
First posted: 2017-12-14
Enrollment: 46
Sex: ALL
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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).
Primary purpose: TREATMENT

Brief 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.

Detailed description: Participants will be 100 individuals (aged 18 to 50) enrolled in outpatient (non- methadone/buprenorphine) treatment for any substance use disorder (other than PCP) at the Substance Abuse Treatment Unit in New Haven. As the goal of this project is to develop interventions that address self-regulation across multiple disorders, we will recruit individuals who have a range of substance use disorders and levels of severity. Our primary Specific Aim will be to evaluate the efficacy of the cognitive-remediation program relative to the control condition control on the indicators of cognitive-affective functioning and substance use, testing the hypothesis that individuals randomized to the cognitive remediation program will demonstrate improved functioning on the cognitive-affective battery as well as reduced real-world substance abuse. We will also explore potential moderators of response to the training, including baseline measures of cognitive-affective function.

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

Primary outcomes:
measure: Change in Stop Signal Reaction Time
timeFrame: Training visit 1 through 4 weeks of training
measure: Change From Pre-Post in Substance Use
timeFrame: 4 weeks before First Training Session through the 4-week training period
measure: 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)
timeFrame: from the week prior to training to the week after training
measure: Change in Experimental Performance-Change in Percentage of Risky Choices Under Risk Condition of the Lottery Task
timeFrame: Training visit 1 through 4 weeks of training
measure: Change in Experimental Performance- Change in Percentage of Ambiguous Choices Under 24% Ambiguity in Lottery Task
timeFrame: Training visit 1 through 4 weeks of training
measure: Change in Experimental Performance- Paced Auditory Serial Addition Test (PASAT)
timeFrame: from the week prior to training (pre) to the week after training (post)
measure: Change in Pre-Post Cognitive Affective Battery: Digit Backwards
timeFrame: from the week prior to training (pre) to the week after training (post)
measure: Change in Pre-Post Cognitive Affective Battery: Breath Holding
timeFrame: from the week prior to training (pre) to the week after training (post)
measure: Change in Pre-Post Cognitive Affective Battery: Perceived Stress Scale
timeFrame: from the week prior to training (pre) to the week after training (post)
measure: Change in Pre-Post Cognitive Affective Battery: Delay Discounting
timeFrame: from the week prior to training (pre) to the week after training (post)
Secondary outcomes:
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Substance Abuse Treatment Center (SATU)
state: Connecticut
Study officials:
affiliation: Yale University
name: Arielle Baskin-Sommers, PhD
role: PRINCIPAL_INVESTIGATOR
References: