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

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ClinicalTrials.gov Identifier: NCT01410110
Recruitment Status : Completed
First Posted : August 4, 2011
Results First Posted : January 19, 2015
Last Update Posted : January 19, 2015
Sponsor:
Information provided by (Responsible Party):
Morris D. Bell, Yale University

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Substance Abuse
Substance Dependence
Cognitive Impairment
Interventions Behavioral: Cognitive Training + Work Therapy
Behavioral: Work Therapy
Enrollment 48
Recruitment Details 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 Following informed consent, participants completed baseline assessments and their VA medical record was reviewed to determine whether they met inclusion/exclusion criteria.
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Period Title: Overall Study
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
Reason Not Completed
Withdrawal by Subject             4             2
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only Total
Hide Arm/Group Description

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Total of all reporting groups
Overall Number of Baseline Participants 24 24 48
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
51.3  (9.7) 53.8  (7.4) 52.55  (8.55)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Female
2
   8.3%
1
   4.2%
3
   6.3%
Male
22
  91.7%
23
  95.8%
45
  93.8%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Hispanic or Latino
0
   0.0%
0
   0.0%
0
   0.0%
Not Hispanic or Latino
24
 100.0%
24
 100.0%
48
 100.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
American Indian or Alaska Native
0
   0.0%
3
  12.5%
3
   6.3%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
11
  45.8%
13
  54.2%
24
  50.0%
White
13
  54.2%
7
  29.2%
20
  41.7%
More than one race
0
   0.0%
1
   4.2%
1
   2.1%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Marital Status  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Married 3 6 9
Never Married 5 8 13
Divorced/Widowed 16 10 26
Axis 1 Primary Diagnosis  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Alcohol Use Disorder 13 15 28
Cocaine 3 7 10
Opiods 6 0 6
Other 2 2 4
Education  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 24 participants 24 participants 48 participants
13.2  (1.6) 12.21  (1.5) 12.71  (1.55)
Felony Convictions  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Yes 11 12 23
No 13 12 25
Disability (SSDI or VA Service Connected)  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 24 participants 24 participants 48 participants
Yes 2 3 5
No 22 21 43
Global Assessment of Function (GAF)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 24 participants 24 participants 48 participants
45.17  (3.6) 47.67  (5.9) 46.42  (4.75)
[1]
Measure Description: The Global Assessment of Function Scale range is from 1 to 100. Higher scores indicate better functioning.
1.Primary Outcome
Title Days of Sobriety in First 90 Days
Hide Description 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.
Time Frame 3 months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Days of Sobriety
87.3  (7.8) 84.64  (18.2)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments t-test for equality of means
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .55
Comments a prior threshold p < .05
Method t-test, 2 sided
Comments df = 40
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.66
Confidence Interval (2-Sided) 95%
-11.57 to 6.25
Parameter Dispersion
Type: Standard Error of the mean
Value: 4.41
Estimation Comments [Not Specified]
2.Primary Outcome
Title Days of Use in Prior 30 Days
Hide Description Days 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.
Time Frame 30 Days Prior to 6 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 20 22
Mean (Standard Deviation)
Unit of Measure: Days of Use
4.35  (9.44) 1.86  (5.96)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <.31
Comments a priori threshold p < .05
Method t-test, 2 sided
Comments [Not Specified]
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value -2.49
Confidence Interval (2-Sided) 95%
-7.36 to 2.39
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.41
Estimation Comments [Not Specified]
3.Primary Outcome
Title Weeks of Sobriety
Hide Description 0 to 26 Weeks. Higher number of Weeks is better.
Time Frame 26 weeks
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
1 additional participant in Work Therapy Only had missing data for this variable.
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 20 21
Mean (Standard Deviation)
Unit of Measure: Weeks
23.80  (2.8) 23.95  (3.25)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .87
Comments a priori threshold p < .05
Method t-test, 2 sided
Comments df=39
Method of Estimation Estimation Parameter Mean Difference (Final Values)
Estimated Value .152
Confidence Interval (2-Sided) 95%
-1.77 to 2.08
Parameter Dispersion
Type: Standard Error of the mean
Value: .952
Estimation Comments [Not Specified]
4.Secondary Outcome
Title Attention Index
Hide Description Index 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.
Time Frame Baseline, 3 month and 6 month follow-up
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: T Scores
Baseline 48.08  (8.26) 41.79  (8.87)
3 Month 48.17  (8.74) 43.19  (9.54)
6 Month 50.36  (10.14) 43.55  (10.24)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments F Test (df = 1,39.32), Type III Fixed Effects for Time X Condition
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .86
Comments Time X Condition
Method Mixed Models Analysis
Comments Mixed Models allows for all randomized participants (N=48) to be included in the model.
Method of Estimation Estimation Parameter Slope
Estimated Value .162
Confidence Interval (2-Sided) 95%
-1.73 to 2.05
Parameter Dispersion
Type: Standard Error of the mean
Value: .94
Estimation Comments [Not Specified]
5.Secondary Outcome
Title Processing Speed Index
Hide Description Wechsler 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.
Time Frame Baseline, 3 Months, 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: T Scores
Baseline 49.42  (7.46) 45.06  (9.14)
3 Months 49.61  (9.04) 45.57  (10.03)
6 Months 50.42  (9.39) 46.90  (9.54)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy
Comments Type III Fixed Effects for Time X Condition F Test (df = 1,36.86)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .67
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time X Condition
Method of Estimation Estimation Parameter Slope
Estimated Value -.37
Confidence Interval (2-Sided) 95%
-2.07 to 1.33
Parameter Dispersion
Type: Standard Error of the mean
Value: .84
Estimation Comments [Not Specified]
6.Secondary Outcome
Title Verbal and Visual Learning and Memory
Hide Description Brief 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.
Time Frame Baseline, 3 Months, 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: T Scores
Baseline 38.13  (9.39) 33.5  (10.89)
3 Months 40.48  (8.3) 36.67  (11.1)
6 Months 39.5  (11.3) 38.3  (9.9)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments Type III Fixed Effects for Time X Condition, F Test F (df = 1,42.4)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .50
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time X Condition
Method of Estimation Estimation Parameter Slope
Estimated Value -.42
Confidence Interval (2-Sided) 95%
-1.67 to .83
Parameter Dispersion
Type: Standard Error of the mean
Value: .62
Estimation Comments [Not Specified]
7.Secondary Outcome
Title Verbal and Visual Working Memory
Hide Description WAIS 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.
Time Frame Baseline, 3 Month, 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: T Scores
Baseline 45.43  (6.26) 43.25  (8.49)
3 Month 46.25  (12.1) 40.62  (7.5)
6 Month 50.00  (9.37) 42.62  (9.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments Type III Fixed Effects Time X Condition F Test (df = 1,70.15)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .008
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time X Condition
Method of Estimation Estimation Parameter Slope
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
.32 to 2.01
Parameter Dispersion
Type: Standard Error of the mean
Value: .42
Estimation Comments [Not Specified]
8.Secondary Outcome
Title Executive Function
Hide Description Mazes, 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.
Time Frame Baseline, 3 Months, 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: T Scores
Baseline 45.11  (6.75) 42.59  (7.72)
3 Month 48.8  (8.4) 43.26  (8.7)
6 Month 49.53  (9.8) 43.8  (8.3)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments Type III Fixed Effects Time X Condition F Test (df = 1,37.8)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments [Not Specified]
Method Mixed Models Analysis
Comments Time X Condition
Method of Estimation Estimation Parameter Slope
Estimated Value 2.025
Confidence Interval (2-Sided) 95%
.169 to 3.93
Parameter Dispersion
Type: Standard Error of the mean
Value: .93
Estimation Comments [Not Specified]
9.Secondary Outcome
Title Global Index
Hide Description Comprised 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.
Time Frame Baseline, 3 Months, 6 Months
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description:

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

Overall Number of Participants Analyzed 24 24
Mean (Standard Deviation)
Unit of Measure: T Scores
Intake 45.23  (5.36) 41.25  (7.54)
3 Months 46.63  (7.55) 41.86  (7.66)
6 Months 47.95  (7.95) 43.05  (7.68)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Cognitive Training + Work Therapy, Work Therapy Only
Comments Type III Fixed Effects for Time X Condition F Test (df = 1,39.8)
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .17
Comments a priori p-value is .05. for two-tailed test. Positive estimated value is in the direction of the experimental condition.
Method Mixed Models Analysis
Comments Time X Condition
Method of Estimation Estimation Parameter Slope
Estimated Value 3.86
Confidence Interval (2-Sided) 95%
-1.73 to 9.46
Parameter Dispersion
Type: Standard Error of the mean
Value: 2.77
Estimation Comments [Not Specified]
Time Frame Entire length of study
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Cognitive Training + Work Therapy Work Therapy Only
Hide Arm/Group Description

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

Same work therapy but for 20 hours per week.

Work Therapy: 20 hours per week of work therapy

All-Cause Mortality
Cognitive Training + Work Therapy Work Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
Cognitive Training + Work Therapy Work Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Cognitive Training + Work Therapy Work Therapy Only
Affected / at Risk (%) Affected / at Risk (%)
Total   0/24 (0.00%)   0/24 (0.00%) 
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.
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
Responsible Party: Morris D. Bell, Yale University
ClinicalTrials.gov Identifier: NCT01410110     History of Changes
Other Study ID Numbers: 1011007601
R21DA030744-02 ( U.S. NIH Grant/Contract )
First Submitted: August 2, 2011
First Posted: August 4, 2011
Results First Submitted: December 15, 2014
Results First Posted: January 19, 2015
Last Update Posted: January 19, 2015