Targeting Self-regulatory Deficits Through Cognitive Remediation Intervention
| Status: | Recruiting |
|---|---|
| Conditions: | Psychiatric |
| Therapuetic Areas: | Psychiatry / Psychology |
| Healthy: | No |
| Age Range: | 18 - 50 |
| Updated: | 8/30/2018 |
| Start Date: | January 22, 2018 |
| End Date: | January 2020 |
| Contact: | Yudilyn Jaramillo, MPH |
| Email: | yudilyn.jamarillo@yale.edu |
| Phone: | 203-974-5777 |
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.
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.
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.
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.
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
We found this trial at
1
site
1 Long Wharf Drive
New Haven, Connecticut 06511
New Haven, Connecticut 06511
Principal Investigator: Arielle Baskin-Sommers, PhD
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