NCT03373240

Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 46 (actual)
• Sponsor: Yale University · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Drug Use Disorders

Interventions

Type	Name	Description
BEHAVIORAL	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.
BEHAVIORAL	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.

Timeline

• Start date: 2018-01-22
• Primary completion: 2019-10-17
• Completion: 2019-10-17
• First posted: 2017-12-14
• Last updated: 2021-01-08
• Results posted: 2021-01-08

Locations

1 site across 1 country: United States