Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

Yale University

Status: Completed

Conditions: Drug Use Disorders

Treatments: Behavioral: TAU plus Control Tasks; Behavioral: TAU plus Cognitive Remediation Program

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT03373240

2P50DA009241-21 (U.S. NIH Grant/Contract)

2000021496

Details and patient eligibility

About

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.

Full 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.

Enrollment: 46 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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46 participants in 2 patient groups, including a placebo group

TAU plus Cognitive Remediation Program

Experimental group

Description:

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.

Treatment:

Behavioral: TAU plus Cognitive Remediation Program

TAU plus Control Tasks

Placebo Comparator group

Description:

Treatment normally received at this clinic that generally includes individual or group sessions and regular urine monitoring PLUS a series of computerized word games.

Treatment:

Behavioral: TAU plus Control Tasks