Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Morris D. Bell, Yale University
ClinicalTrials.gov Identifier:
NCT01410110
First received: August 2, 2011
Last updated: January 14, 2015
Last verified: December 2014
Results First Received: December 15, 2014  
Study Type: Interventional
Study Design: Allocation: Randomized;   Endpoint Classification: Efficacy Study;   Intervention Model: Parallel Assignment;   Masking: Single Blind (Outcomes Assessor);   Primary Purpose: Treatment
Conditions: Substance Abuse
Substance Dependence
Cognitive Impairment
Interventions: Behavioral: Cognitive Training + Work Therapy
Behavioral: Work Therapy

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Recruitment was by referral from clinicians at VA Substance Abuse program including a 21 day substance abuse day program and a 30 day residential program. Recruitment began in January 2011 and was completed in March 2014.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
Following informed consent, participants completed baseline assessments and their VA medical record was reviewed to determine whether they met inclusion/exclusion criteria.

Reporting Groups
  Description
Cognitive Training + Work Therapy

Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.

Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.

Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy

Work Therapy Only

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy


Participant Flow:   Overall Study
    Cognitive Training + Work Therapy     Work Therapy Only  
STARTED     24     24  
Randomization     24     24  
3 Months (End of Intervention)     20     22  
6 Month Follow-up     20     22  
COMPLETED     20     22  
NOT COMPLETED     4     2  
Withdrawal by Subject                 4                 2  



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Cognitive Training + Work Therapy

Cognitive Training using auditory and visual Positscience software 5 hours/per week for 13 weeks.

Work Therapy for 15 hours per week at half minimum wage doing entry level duties at medical center job sites, supervised by regular medical center staff.

Cognitive Training + Work Therapy: Cognitive training for 5 hours per week for 13 weeks and 15 hours of work therapy

Work Therapy Only

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Total Total of all reporting groups

Baseline Measures
    Cognitive Training + Work Therapy     Work Therapy Only     Total  
Number of Participants  
[units: participants]
  24     24     48  
Age  
[units: years]
Mean ± Standard Deviation
  51.3  ± 9.7     53.8  ± 7.4     52.55  ± 8.55  
Gender  
[units: participants]
     
Female     2     1     3  
Male     22     23     45  
Ethnicity (NIH/OMB)  
[units: participants]
     
Hispanic or Latino     0     0     0  
Not Hispanic or Latino     24     24     48  
Unknown or Not Reported     0     0     0  
Race (NIH/OMB)  
[units: participants]
     
American Indian or Alaska Native     0     3     3  
Asian     0     0     0  
Native Hawaiian or Other Pacific Islander     0     0     0  
Black or African American     11     13     24  
White     13     7     20  
More than one race     0     1     1  
Unknown or Not Reported     0     0     0  
Marital Status  
[units: participants]
     
Married     3     6     9  
Never Married     5     8     13  
Divorced/Widowed     16     10     26  
Axis 1 Primary Diagnosis  
[units: participants]
     
Alcohol Use Disorder     13     15     28  
Cocaine     3     7     10  
Opiods     6     0     6  
Other     2     2     4  
Education  
[units: years]
Mean ± Standard Deviation
  13.2  ± 1.6     12.21  ± 1.5     12.71  ± 1.55  
Felony Convictions  
[units: participants]
     
Yes     11     12     23  
No     13     12     25  
Disability (SSDI or VA Service Connected)  
[units: participants]
     
Yes     2     3     5  
No     22     21     43  
Global Assessment of Function (GAF) [1]
[units: units on a scale]
Mean ± Standard Deviation
  45.17  ± 3.6     47.67  ± 5.9     46.42  ± 4.75  
[1] The Global Assessment of Function Scale range is from 1 to 100. Higher scores indicate better functioning.



  Outcome Measures
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1.  Primary:   Days of Sobriety in First 90 Days   [ Time Frame: 3 months ]

2.  Primary:   Days of Use in Prior 30 Days   [ Time Frame: 30 Days Prior to 6 month follow-up ]

3.  Primary:   Weeks of Sobriety   [ Time Frame: 26 weeks ]

4.  Secondary:   Attention Index   [ Time Frame: Baseline, 3 month and 6 month follow-up ]

5.  Secondary:   Processing Speed Index   [ Time Frame: Baseline, 3 Months, 6 Months ]

6.  Secondary:   Verbal and Visual Learning and Memory   [ Time Frame: Baseline, 3 Months, 6 Months ]

7.  Secondary:   Verbal and Visual Working Memory   [ Time Frame: Baseline, 3 Month, 6 Months ]

8.  Secondary:   Executive Function   [ Time Frame: Baseline, 3 Months, 6 Months ]

9.  Secondary:   Global Index   [ Time Frame: Baseline, 3 Months, 6 Months ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
Use of WT limited recruitment to only those willing to participate in a work program for 13 weeks, reducing generalizability. WT may have powerful effects on sobriety that obscured benefits of CRT. As a pilot, this study was not adequately powered.


  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Morris Bell, Ph.D.
Organization: Yale University School of Medicine
phone: 203-932-5711 ext 2281
e-mail: morris.bell@yale.edu


No publications provided


Responsible Party: Morris D. Bell, Yale University
ClinicalTrials.gov Identifier: NCT01410110     History of Changes
Other Study ID Numbers: 1011007601, R21DA030744-02
Study First Received: August 2, 2011
Results First Received: December 15, 2014
Last Updated: January 14, 2015
Health Authority: United States: Federal Government
United States: Institutional Review Board