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Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention

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ClinicalTrials.gov Identifier: NCT03373240
Recruitment Status : Recruiting
First Posted : December 14, 2017
Last Update Posted : August 28, 2018
Sponsor:
Information provided by (Responsible Party):
Yale University

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.

Condition or disease Intervention/treatment Phase
Drug Use Disorders Behavioral: TAU plus Cognitive Remediation Program Behavioral: TAU plus Control Tasks Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
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).
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
Actual Study Start Date : January 22, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : January 2020

Arm Intervention/treatment
Experimental: 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.
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.

Placebo Comparator: 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.
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.




Primary Outcome Measures :
  1. Change in experimental performance [ Time Frame: 4 weeks ]
    Improved functioning on cognitive-affective battery

  2. Substance Use Calendar [ Time Frame: 4 weeks ]
    Reduced substance use

  3. Change in Pre-Post Cognitive Affective Battery [ Time Frame: 4 weeks ]
    executive function (UPPS), negative emotionality (breath holding, perceived stress), incentive salience (delay discounting)



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03373240


Contacts
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Contact: Yudilyn Jaramillo, MPH 203-974-5777 yudilyn.jamarillo@yale.edu

Locations
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United States, Connecticut
Substance Abuse Treatment Center (SATU) Recruiting
New Haven, Connecticut, United States, 06511
Contact: Yudilyn Jaramillo, MPH         
Principal Investigator: Arielle Baskin-Sommers, PhD         
Sub-Investigator: Kathleen M Carroll, PhD         
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Arielle Baskin-Sommers, PhD Yale University
  Study Documents (Full-Text)

Documents provided by Yale University:
Study Protocol  [PDF] August 23, 2017
Informed Consent Form  [PDF] August 23, 2017
Statistical Analysis Plan  [PDF] August 23, 2017


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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT03373240     History of Changes
Other Study ID Numbers: 2000021496
First Posted: December 14, 2017    Key Record Dates
Last Update Posted: August 28, 2018
Last Verified: August 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Yale University:
Drug use Disorders
Cognitive Remediation

Additional relevant MeSH terms:
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Substance-Related Disorders
Chemically-Induced Disorders
Mental Disorders