Phase 2
N=48
Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
Substance Abuse · Substance Dependence · Cognitive Impairment
Bottom Line
View on ClinicalTrials.gov: NCT01410110 ↗Enrolled (actual)
48
Serious AEs
0.0%
Results posted
Jan 2015
Primary outcome: Primary: Days of Sobriety in First 90 Days — 87.3; 84.64 Days of Sobriety — p=.55
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Cognitive Training + Work Therapy (Behavioral); Work Therapy (Behavioral)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Yale University
- Primary completion
- Dec 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Days of Sobriety in First 90 Days |
87.3; 84.64 | .55 |
| PRIMARY Days of Use in Prior 30 Days |
4.35; 1.86 | <.31 |
| PRIMARY Weeks of Sobriety |
23.80; 23.95 | .87 |
| SECONDARY Attention Index |
48.08; 41.79; 48.17; 43.19; 50.36; 43.55 | .86 |
| SECONDARY Processing Speed Index |
49.42; 45.06; 49.61; 45.57; 50.42; 46.90 | .67 |
| SECONDARY Verbal and Visual Learning and Memory |
38.13; 33.5; 40.48; 36.67; 39.5; 38.3 | .50 |
| SECONDARY Verbal and Visual Working Memory |
45.43; 43.25; 46.25; 40.62; 50.00; 42.62 | .008 sig |
| SECONDARY Executive Function |
45.11; 42.59; 48.8; 43.26; 49.53; 43.8 | .03 sig |
| SECONDARY Global Index |
45.23; 41.25; 46.63; 41.86; 47.95; 43.05 | .17 |
Summary
The initial phase of substance abuse treatment is a vulnerable period for relapse. Cognitive impairments are common during this phase and may reduce the ability to benefit from other forms of substance abuse and rehabilitation services. The study compares a rehabilitation program that combines work therapy with computer-based cognitive training of attention, memory and executive functions to work therapy alone in a 3 months outpatient substance abuse program. It is hypothesized that cognitive training will increase days of sobriety during the active intervention and better substance abuse outcomes at 6 month follow-up.
Eligibility Criteria
Inclusion Criteria
- In the initial phase of treatment for substance abuse or dependence at VACHS.
- Fluency in English 6th grade or higher reading level DSM-IV criteria for any current drug use disorder
- Willingness to attend follow-up assessments at 13 and 26 weeks
- Willingness to submit to observed urine toxicology and breathalyzer screenings
Exclusion Criteria
- Untreated psychotic disorder
- Current prescribed treatment of opioids or benzodiazepines
- Having a legal case that may lead to incarceration during study period
- Residential plans that would interfere with participation
- Developmental disability or medical illness that may significantly compromise cognition or prevent work activity
Data sourced from ClinicalTrials.gov (NCT01410110). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.