Trial Outcomes & Findings for Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment (NCT NCT01410110)
NCT ID: NCT01410110
Last Updated: 2015-01-19
Results Overview
Abstinence will be determined by toxicology screening, breathalyzer and substance abuse calendar weekly during 3 months of active intervention. Days of sobriety has a range of 0 to 90 with higher being a better outcome.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
48 participants
Primary outcome timeframe
3 months
Results posted on
2015-01-19
Participant Flow
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.
Following informed consent, participants completed baseline assessments and their VA medical record was reviewed to determine whether they met inclusion/exclusion criteria.
Participant milestones
| Measure |
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
|
|---|---|---|
|
Overall Study
STARTED
|
24
|
24
|
|
Overall Study
Randomization
|
24
|
24
|
|
Overall Study
3 Months (End of Intervention)
|
20
|
22
|
|
Overall Study
6 Month Follow-up
|
20
|
22
|
|
Overall Study
COMPLETED
|
20
|
22
|
|
Overall Study
NOT COMPLETED
|
4
|
2
|
Reasons for withdrawal
| Measure |
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
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
4
|
2
|
Baseline Characteristics
Cognitive Remediation and Work Therapy in the Initial Phase of Substance Abuse Treatment
Baseline characteristics by cohort
| Measure |
Cognitive Training + Work Therapy
n=24 Participants
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
n=24 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
Total
n=48 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51.3 years
STANDARD_DEVIATION 9.7 • n=99 Participants
|
53.8 years
STANDARD_DEVIATION 7.4 • n=107 Participants
|
52.55 years
STANDARD_DEVIATION 8.55 • n=206 Participants
|
|
Sex: Female, Male
Female
|
2 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
22 Participants
n=99 Participants
|
23 Participants
n=107 Participants
|
45 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=99 Participants
|
24 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
11 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
13 Participants
n=99 Participants
|
7 Participants
n=107 Participants
|
20 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Marital Status
Married
|
3 participants
n=99 Participants
|
6 participants
n=107 Participants
|
9 participants
n=206 Participants
|
|
Marital Status
Never Married
|
5 participants
n=99 Participants
|
8 participants
n=107 Participants
|
13 participants
n=206 Participants
|
|
Marital Status
Divorced/Widowed
|
16 participants
n=99 Participants
|
10 participants
n=107 Participants
|
26 participants
n=206 Participants
|
|
Axis 1 Primary Diagnosis
Alcohol Use Disorder
|
13 participants
n=99 Participants
|
15 participants
n=107 Participants
|
28 participants
n=206 Participants
|
|
Axis 1 Primary Diagnosis
Cocaine
|
3 participants
n=99 Participants
|
7 participants
n=107 Participants
|
10 participants
n=206 Participants
|
|
Axis 1 Primary Diagnosis
Opiods
|
6 participants
n=99 Participants
|
0 participants
n=107 Participants
|
6 participants
n=206 Participants
|
|
Axis 1 Primary Diagnosis
Other
|
2 participants
n=99 Participants
|
2 participants
n=107 Participants
|
4 participants
n=206 Participants
|
|
Education
|
13.2 years
STANDARD_DEVIATION 1.6 • n=99 Participants
|
12.21 years
STANDARD_DEVIATION 1.5 • n=107 Participants
|
12.71 years
STANDARD_DEVIATION 1.55 • n=206 Participants
|
|
Felony Convictions
Yes
|
11 participants
n=99 Participants
|
12 participants
n=107 Participants
|
23 participants
n=206 Participants
|
|
Felony Convictions
No
|
13 participants
n=99 Participants
|
12 participants
n=107 Participants
|
25 participants
n=206 Participants
|
|
Disability (SSDI or VA Service Connected)
Yes
|
2 participants
n=99 Participants
|
3 participants
n=107 Participants
|
5 participants
n=206 Participants
|
|
Disability (SSDI or VA Service Connected)
No
|
22 participants
n=99 Participants
|
21 participants
n=107 Participants
|
43 participants
n=206 Participants
|
|
Global Assessment of Function (GAF)
|
45.17 units on a scale
STANDARD_DEVIATION 3.6 • n=99 Participants
|
47.67 units on a scale
STANDARD_DEVIATION 5.9 • n=107 Participants
|
46.42 units on a scale
STANDARD_DEVIATION 4.75 • n=206 Participants
|
PRIMARY outcome
Timeframe: 3 monthsAbstinence will be determined by toxicology screening, breathalyzer and substance abuse calendar weekly during 3 months of active intervention. Days of sobriety has a range of 0 to 90 with higher being a better outcome.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=20 Participants
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
n=22 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Days of Sobriety in First 90 Days
|
87.3 Days of Sobriety
Standard Deviation 7.8
|
84.64 Days of Sobriety
Standard Deviation 18.2
|
PRIMARY outcome
Timeframe: 30 Days Prior to 6 month follow-upDays of Use based on Time-Line Follow-back, Toxicology Screen, Breathalyzer, and Chart Review. The range at 6 month follow-up is 0 to 30 days of use with more days being a worse outcome.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=20 Participants
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
n=22 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Days of Use in Prior 30 Days
|
4.35 Days of Use
Standard Deviation 9.44
|
1.86 Days of Use
Standard Deviation 5.96
|
PRIMARY outcome
Timeframe: 26 weeksPopulation: 1 additional participant in Work Therapy Only had missing data for this variable.
0 to 26 Weeks. Higher number of Weeks is better.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=20 Participants
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
n=21 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Weeks of Sobriety
|
23.80 Weeks
Standard Deviation 2.8
|
23.95 Weeks
Standard Deviation 3.25
|
SECONDARY outcome
Timeframe: Baseline, 3 month and 6 month follow-upIndex comprised on Trails A and Continuous Performance Test. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=24 Participants
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
n=24 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Attention Index
Baseline
|
48.08 T Scores
Standard Deviation 8.26
|
41.79 T Scores
Standard Deviation 8.87
|
|
Attention Index
3 Month
|
48.17 T Scores
Standard Deviation 8.74
|
43.19 T Scores
Standard Deviation 9.54
|
|
Attention Index
6 Month
|
50.36 T Scores
Standard Deviation 10.14
|
43.55 T Scores
Standard Deviation 10.24
|
SECONDARY outcome
Timeframe: Baseline, 3 Months, 6 MonthsWechsler Adult Intelligence Scale (WAIS) Digit Coding and Symbol Search. T scores for the assessments are averaged. T scores range from 30 to 80 with a mean of 50. Higher scores are better.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=24 Participants
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
n=24 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Processing Speed Index
Baseline
|
49.42 T Scores
Standard Deviation 7.46
|
45.06 T Scores
Standard Deviation 9.14
|
|
Processing Speed Index
3 Months
|
49.61 T Scores
Standard Deviation 9.04
|
45.57 T Scores
Standard Deviation 10.03
|
|
Processing Speed Index
6 Months
|
50.42 T Scores
Standard Deviation 9.39
|
46.90 T Scores
Standard Deviation 9.54
|
SECONDARY outcome
Timeframe: Baseline, 3 Months, 6 MonthsBrief Visual-Spatial Memory Test (BVMT) and Hopkins Verbal Learning and Memory Test (HVLT). Total Score T Scores for tests were averaged. T score range is 30 to 80 with a mean of 50. Higher scores are better.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=24 Participants
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
n=24 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Verbal and Visual Learning and Memory
Baseline
|
38.13 T Scores
Standard Deviation 9.39
|
33.5 T Scores
Standard Deviation 10.89
|
|
Verbal and Visual Learning and Memory
3 Months
|
40.48 T Scores
Standard Deviation 8.3
|
36.67 T Scores
Standard Deviation 11.1
|
|
Verbal and Visual Learning and Memory
6 Months
|
39.5 T Scores
Standard Deviation 11.3
|
38.3 T Scores
Standard Deviation 9.9
|
SECONDARY outcome
Timeframe: Baseline, 3 Month, 6 MonthsWAIS Digit Span and Wechsler Memory Scale (WMS) Spatial Span. T Scores are averaged. T Scores range from 30 to 80 with a mean of 50. Higher scores are better.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=24 Participants
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
n=24 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Verbal and Visual Working Memory
Baseline
|
45.43 T Scores
Standard Deviation 6.26
|
43.25 T Scores
Standard Deviation 8.49
|
|
Verbal and Visual Working Memory
3 Month
|
46.25 T Scores
Standard Deviation 12.1
|
40.62 T Scores
Standard Deviation 7.5
|
|
Verbal and Visual Working Memory
6 Month
|
50.00 T Scores
Standard Deviation 9.37
|
42.62 T Scores
Standard Deviation 9.3
|
SECONDARY outcome
Timeframe: Baseline, 3 Months, 6 MonthsMazes, Wisconsin Card Sorting Task (WCST) Perseverative Error, Non-Perseverative Error, Conceptual Level. T Scores for each variable were averaged together. T Scores have a range of 30 to 80 with a mean of 50. Higher scores are better.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=24 Participants
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
n=24 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Executive Function
Baseline
|
45.11 T Scores
Standard Deviation 6.75
|
42.59 T Scores
Standard Deviation 7.72
|
|
Executive Function
3 Month
|
48.8 T Scores
Standard Deviation 8.4
|
43.26 T Scores
Standard Deviation 8.7
|
|
Executive Function
6 Month
|
49.53 T Scores
Standard Deviation 9.8
|
43.8 T Scores
Standard Deviation 8.3
|
SECONDARY outcome
Timeframe: Baseline, 3 Months, 6 MonthsComprised of the average of 5 Index T Scores (Attention, Processing Speed, Visual and Verbal Memory and Learning, Working Memory and Executive Function). T Scores range from 30 to 80 with a mean of 50. Higher scores are better.
Outcome measures
| Measure |
Cognitive Training + Work Therapy
n=24 Participants
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
n=24 Participants
Same work therapy but for 20 hours per week.
Work Therapy: 20 hours per week of work therapy
|
|---|---|---|
|
Global Index
Intake
|
45.23 T Scores
Standard Deviation 5.36
|
41.25 T Scores
Standard Deviation 7.54
|
|
Global Index
3 Months
|
46.63 T Scores
Standard Deviation 7.55
|
41.86 T Scores
Standard Deviation 7.66
|
|
Global Index
6 Months
|
47.95 T Scores
Standard Deviation 7.95
|
43.05 T Scores
Standard Deviation 7.68
|
Adverse Events
Cognitive Training + Work Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Work Therapy Only
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place