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Preventing Violence Among Veterans in Substance Use Disorder Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01337973
Recruitment Status : Completed
First Posted : April 19, 2011
Results First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Information provided by (Responsible Party):
VA Office of Research and Development

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Factorial Assignment;   Masking: Single (Outcomes Assessor);   Primary Purpose: Treatment
Conditions Aggression
Substance-Related Disorders
Interventions Behavioral: MI-CBT
Behavioral: MI-CBT+CC
Behavioral: E-TAU
Enrollment 180
Recruitment Details Participants were recruited from June 2012-June 2015 from outpatient VA mental health programs (Substance Use Disorder, Substance use Disorder Intensive Outpatient, General Mental Health).
Pre-assignment Details Of 1097 eligible for screening, 183 refused participation (17%), 75 (7%) were missed and 839 completed the screening assessment. Of those completing screening, 639 were not eligible for the RCT and 20 refused further participation. Thus, 180 out of 200 eligible veterans (90%) were randomized to one of the three treatment conditions.
Arm/Group Title Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU
Hide Arm/Group Description

MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)

MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches

MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)

MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention

E-TAU (enhanced treatment as usual - includes brief session and provision of resources)

E-TAU: Enhanced Treatment as Usual

Period Title: Overall Study
Started 60 60 60
Completed 44 45 49
Not Completed 16 15 11
Reason Not Completed
Lost to Follow-up             2             4             3
Death             1             2             1
Withdrawal by Subject             10             8             4
missing data on primary outcome             3             1             3
Arm/Group Title Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU Total
Hide Arm/Group Description

MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)

MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches

MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)

MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention

E-TAU (enhanced treatment as usual - includes brief session and provision of resources)

E-TAU: Enhanced Treatment as Usual

Total of all reporting groups
Overall Number of Baseline Participants 60 60 60 180
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 60 participants 60 participants 60 participants 180 participants
39.9  (12.9) 44.9  (12.9) 42.9  (12.8) 42.6  (13.0)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Female
5
   8.3%
5
   8.3%
5
   8.3%
15
   8.3%
Male
55
  91.7%
55
  91.7%
55
  91.7%
165
  91.7%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
Hispanic or Latino
2
   3.3%
2
   3.3%
2
   3.3%
6
   3.3%
Not Hispanic or Latino
55
  91.7%
55
  91.7%
57
  95.0%
167
  92.8%
Unknown or Not Reported
3
   5.0%
3
   5.0%
1
   1.7%
7
   3.9%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 60 participants 60 participants 60 participants 180 participants
American Indian or Alaska Native
0
   0.0%
1
   1.7%
0
   0.0%
1
   0.6%
Asian
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
14
  23.3%
18
  30.0%
19
  31.7%
51
  28.3%
White
41
  68.3%
35
  58.3%
38
  63.3%
114
  63.3%
More than one race
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Unknown or Not Reported
5
   8.3%
6
  10.0%
3
   5.0%
14
   7.8%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
United States Number Analyzed 60 participants 60 participants 60 participants 180 participants
60
 100.0%
60
 100.0%
60
 100.0%
180
 100.0%
1.Primary Outcome
Title Conflict Tactics Scale-Structured Interview (CTS-SI)
Hide Description The CTS-SI is a semi-structured interview assessing interpersonal violence (violence severity, injury and characteristics of interpersonal conflict incidents). Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the month rate of various types of interpersonal aggression from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants. There were primary aggression outcomes (overall physical aggression, injuring another person), and secondary aggression outcomes (partner physical aggression and injury, nonpartner physical aggression and injury).
Time Frame % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
Hide Outcome Measure Data
Hide Analysis Population Description
Main analyses used General Estimating Equations which accounts for missing data. Results in tables below are from bivariate analyses.
Arm/Group Title Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU
Hide Arm/Group Description:

MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)

MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches

MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)

MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention

E-TAU (enhanced treatment as usual - includes brief session and provision of resources)

E-TAU: Enhanced Treatment as Usual

Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage change
Overall physical aggression % change from baseline -90 -90 -94
Overall Injury Perpetration % change from baseline -82 -91 -86
Partner physical aggression % change from baseline -92 -91 -97
Partner injury % change from baseline -100 -85 -61
Nonpartner physical aggresion % change from baseli -88 -89 -90
Nonpartner injury % change from baseline -76 -93 -99
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z value: -4.65
Method of Estimation Estimation Parameter Coefficient estimate
Estimated Value 0.82
Confidence Interval (2-Sided) 95%
0.37 to 1.84
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -2.83
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 0.62
Confidence Interval (2-Sided) 95%
0.30 to 1.29
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -3.31
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 1.16
Confidence Interval (2-Sided) 95%
0.36 to 3.77
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -2.26
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 0.51
Confidence Interval (2-Sided) 95%
0.19 to 1.38
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -3.79
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 1.22
Confidence Interval (2-Sided) 95%
0.66 to 2.28
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -2.01
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 0.80
Confidence Interval (2-Sided) 95%
0.32 to 1.98
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -4.81
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 0.60
Confidence Interval (2-Sided) 95%
0.25 to 1.46
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury perpetration % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -3.74
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 1.05
Confidence Interval (2-Sided) 95%
0.45 to 2.44
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -2.59
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.13 to 1.78
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -1.81
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 0.48
Confidence Interval (2-Sided) 95%
0.16 to 1.47
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -4.10
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 1.12
Confidence Interval (2-Sided) 95%
0.60 to 2.08
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner injury % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -3.17
Method of Estimation Estimation Parameter Coefficient Estimate
Estimated Value 1.09
Confidence Interval (2-Sided) 95%
0.40 to 2.95
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 13
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -4.69
Hide Statistical Analysis 14
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall injury % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -3.32
Hide Statistical Analysis 15
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -2.90
Hide Statistical Analysis 16
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to partner injury % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z Score: -1.02
Hide Statistical Analysis 17
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to non-partner physical aggression % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z Score: -4.01
Hide Statistical Analysis 18
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments Bivariate analyses examined change from baseline to follow up of primary and secondary outcomes measures using Wilcoxon sign rank tests. This test applies to overall non-partner injury % change from baseline
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p < 0.05. Scores are reported stratified by whether they are less than .05 less than .01 and less than .001 respectively.
Method Wilcoxon Z
Comments Wilcoxon Z score: -3.21
2.Secondary Outcome
Title Percent Change in the Percentage of Days of Substance Use for Each Substance
Hide Description Data was collected via a Time-line Follow Back interview. Semi-structured interview assessing alcohol and drug use. Baseline data collection assessed the 180 days prior to enrollment, and follow-up data was collected at 3 and 6 months for the prior 90 days, and at 12 months for the past 180 days. The analysis below compares the monthly rate of various types of substance use (heavy drinking, cocaine, marijuana, and illicit) from the period pre-baseline to the monthly rate post-intervention (across all 12 months of follow-up) in the form of % difference. (% days use for each substance) Means at baseline, 3 , 6 and 12 months were compared resulting in a number with no measure of dispersion. Values were calculated across all participants.
Time Frame % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data
Hide Outcome Measure Data
Hide Analysis Population Description
Main analyses used General Estimating Equations which accounts for missing data. Results in data table are from bivariate analyses.
Arm/Group Title Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU
Hide Arm/Group Description:

MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)

MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches

MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)

MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention

E-TAU (enhanced treatment as usual - includes brief session and provision of resources)

E-TAU: Enhanced Treatment as Usual

Overall Number of Participants Analyzed 60 60 60
Measure Type: Number
Unit of Measure: percentage of change
Heavy Drinking % change from baseline -68 -59 -55
cocaine use % change from baseline -83 -86 -56
marijuana use % change from baseline -40 -42 -44
Overall illicit drug use % change from baseline -52 -50 -57
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to heavy drinking % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -3.52
Method of Estimation Estimation Parameter Coefficient estimate
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.62 to 1.47
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to cocaine use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -2.98
Method of Estimation Estimation Parameter coefficient estimate
Estimated Value 0.49
Confidence Interval (2-Sided) 95%
0.18 to 1.32
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to marijuana use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -2.13
Method of Estimation Estimation Parameter coefficient estimate
Estimated Value 0.85
Confidence Interval (2-Sided) 95%
0.4 to 1.8
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 4
Statistical Analysis Overview Comparison Group Selection Arm 1: MI-CBT
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to illicit drug use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -2.48
Method of Estimation Estimation Parameter coefficient estimate
Estimated Value 0.84
Confidence Interval (2-Sided) 95%
0.54 to 1.32
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 5
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to heavy drinking % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -4.94
Method of Estimation Estimation Parameter coefficient estimate
Estimated Value 1.15
Confidence Interval (2-Sided) 95%
0.78 to 1.71
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 6
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to cocaine use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -2.56
Method of Estimation Estimation Parameter coefficient estimate
Estimated Value 0.61
Confidence Interval (2-Sided) 95%
0.17 to 2.16
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 7
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to marijuana use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.01
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -2.86
Method of Estimation Estimation Parameter coefficient estimate
Estimated Value 1.18
Confidence Interval (2-Sided) 95%
0.57 to 2.44
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 8
Statistical Analysis Overview Comparison Group Selection Arm 2: MI-CBT+CC
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to illicit drug use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -3.51
Method of Estimation Estimation Parameter coefficient estimate
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.61 to 1.48
Estimation Comments E-TAU arm is the referent group
Hide Statistical Analysis 9
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to heavy drinking % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.001
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -4.65
Hide Statistical Analysis 10
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to cocaine use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -1.45
Hide Statistical Analysis 11
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to marijuana use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value >0.05
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -1.5
Hide Statistical Analysis 12
Statistical Analysis Overview Comparison Group Selection Arm 3: E-TAU
Comments

Bivariate analyses examined change from baseline to follow up of substance use outcomes measures using Wilcoxon sign rank tests.

This test applies to illicit drug use % change from baseline

Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value <0.05
Comments The threshold for significance was p<0.05. Scores are reported stratified by whether they are less than 0.05, less than 0.01, and less than 0.001.
Method Wilcoxon Z
Comments Wilcoxon Z value: -2.58
Time Frame [Not Specified]
Adverse Event Reporting Description In the event of participant death, cause of death is unknown.
 
Arm/Group Title Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU
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MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches)

MI-CBT: Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches

MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention)

MI-CBT+CC: Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention

E-TAU (enhanced treatment as usual - includes brief session and provision of resources)

E-TAU: Enhanced Treatment as Usual

All-Cause Mortality
Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   1/60 (1.67%)      2/60 (3.33%)      1/60 (1.67%)    
Hide Serious Adverse Events
Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   1/60 (1.67%)      2/60 (3.33%)      1/60 (1.67%)    
Social circumstances       
Participant Death  [1]  1/60 (1.67%)  1 2/60 (3.33%)  2 1/60 (1.67%)  1
Indicates events were collected by systematic assessment
[1]
There were 4 serious adverse events involving participant deaths. These were immediately reported to our IRB, and none of the events was considered to be study related.
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
Arm 1: MI-CBT Arm 2: MI-CBT+CC Arm 3: E-TAU
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   0/60 (0.00%)      0/60 (0.00%)      0/60 (0.00%)    
We fell short of recruitment goal of 210 participants and had a low number of women per group. Rates of aggression at each follow-up were very low so we collapsed across the 3,6 & 12 month follow-ups when examining changes from baseline to follow-up.
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Stephen Chermack, Ph.D.
Organization: VA Ann Arbor
Phone: 734 845-5046
EMail: chermack@umich.edu
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Responsible Party: VA Office of Research and Development
ClinicalTrials.gov Identifier: NCT01337973    
Other Study ID Numbers: IIR 09-333
HX000294 ( Other Grant/Funding Number: VA Merit Review Grant )
First Submitted: December 17, 2010
First Posted: April 19, 2011
Results First Submitted: December 21, 2017
Results First Posted: September 6, 2019
Last Update Posted: September 6, 2019