Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

NCT ID: NCT03373240

Last Updated: 2021-01-08

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-01-22
• Study Completion Date: 2019-10-17

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.

Conditions

Drug Use Disorders

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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 learning and decision making.

Group Type: EXPERIMENTAL

TAU plus Cognitive Remediation Program

Intervention Type: BEHAVIORAL

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.

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.

Group Type: PLACEBO_COMPARATOR

TAU plus Control Tasks

Intervention Type: BEHAVIORAL

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

Interventions

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.

Intervention Type: 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.

Intervention Type: BEHAVIORAL

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 50 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

National Institute on Drug Abuse (NIDA)

NIH

Sponsor Role: collaborator

Yale University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Arielle Baskin-Sommers, PhD

Role: PRINCIPAL_INVESTIGATOR

Yale University

Locations

Substance Abuse Treatment Center (SATU)

New Haven, Connecticut, United States

Countries

United States

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Document Type: Study Protocol

View Document

Other Identifiers

2P50DA009241-21

Identifier Type: NIH

Identifier Source: secondary_id

View Link

2000021496

Identifier Type: -

Identifier Source: org_study_id