Aggression, Substance-Related Disorders
Conditions
Keywords
violence, aggression, Substance-Related Disorders, Alcohol-Related Disorders, Drug-Related Disorders
Brief summary
The purpose of this study is to examine the impact on both clinical (violence and substance use) outcomes and health services use (substance use disorder and mental health treatment) compared to standard SUD treatment (enhanced treatment as usual) of 1. an integrated Motivational Interviewing-Cognitive Behavioral Therapy (MI-CBT) violence prevention treatment intervention delivered during the 8-week early substance use disorder treatment phase; and 2. MI-CBT plus a continuing care (CC) intervention for the 3-month continuing care period following the early treatment phase MI-CBT+CC). The study will provide important new information regarding the role and relative impact of both early treatment and continuing care interventions designed to impact substance use and violence, and whether combining such interventions yields additional benefits.
Detailed description
Objective: Rates of violence in Substance Use Disorder (SUD) treatment samples often exceed 50%, with studies showing rates of past-year violence \>70% when considering violence occurring with either intimate partners or others. Violence has numerous costs to Veterans and their families, in terms of physical (e.g., injuries) and psychosocial problems (mental health, legal problems, marital problems, poorer functioning for their children, etc.). To date, only one treatment approach (Behavioral Couples Therapy - BCT) has been established that reduces both substance use and violence, and BCT focuses exclusively on the couples' relationship. Given that a small proportion of Veterans in SUD treatment have a partner willing or able to attend treatment, and that a substantial amount of violence occurs with non-partners, there is a clear need for interventions that do not require partner participation and focus on violence and relapse prevention more generally. Based on prior findings, new intervention approaches targeting the use of violence prevention skills and means of sustaining substance use remission are needed. The primary objectives of this study are to examine the impact on both substance use and violence outcomes of: 1. an acute treatment phase integrated Motivational Interviewing-Cognitive Behavioral Treatment intervention (MI-CBT); and 2. MI-CBT plus a violence and substance use prevention Continuing Care intervention (MI-CBT+CC) intervention. Research Plan: Participants will be randomized to one of three conditions: MI-CBT, MI-CBT+CC or an enhanced treatment as usual (E-TAU) control condition with follow-up interviews targeting violence and substance use outcomes at 3, 6 and 12-months. The MI-CBT intervention involves six individual sessions delivered during the acute SUD treatment phase, combines Motivational Interviewing (MI) and CBT approaches targeting violence and substance use, and has been developed, piloted and refined by the investigators. The MI-CBT+CC intervention includes acute phase MI-CBT plus weekly telephone sessions for an additional 3-month period, and is designed to address both post-treatment violence and substance use through facilitating SUD remission and use of violence prevention skills. The MI-CBT+CC intervention is adapted from a continuing care intervention shown to help consolidate and maintain gains made in treatment. Methods: Veterans with substance use disorders will be recruited from the Substance Abuse Clinic (SAC) at the VA Ann Arbor Healthcare system. Approximately 855 Veterans enrolling in SAC will be consented and screened, and those screening positive for severe and recent violence (\ 30%) and meeting other project inclusion/exclusion criteria will be eligible for participation in the randomized controlled trial (n = 210). The clinical interventions will be delivered by master's level clinicians, who will be monitored and supervised by licensed psychologists. Primary dependent measures (violence, substance use) will be measured at baseline and follow-up interviews, and the impact of the interventions on services use during the follow-up period also will be examined.
Interventions
BEHAVIORALMI-CBT
Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches
BEHAVIORALMI-CBT+CC
Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention
BEHAVIORALE-TAU
Enhanced Treatment as Usual
Sponsors
VA Office of Research and Development
Study design
Allocation
RANDOMIZED
Intervention model
FACTORIAL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Participants with severe and recent violence (i.e., injuring another person in the past year) will be eligible for the RCT. * Eligible patients also will meet DSM-IV criteria for either alcohol or illicit drug (e.g., cocaine, marijuana, opiates, etc.) abuse/dependence. * The study will include those with comorbid mood and/or anxiety problems (e.g., depression, PTSD and other anxiety disorders), whether or not on medication at the point of recruitment, with the exception of those who have schizophrenia and/or are mentally incompetent (e.g., unable to provide informed consent). * A brief mental status screen will with an established cutoff will be required for competency.
Exclusion criteria
* Participants who are suicidal (ideation, intent and plan) at the point of recruitment will not be enrolled in the study. Rather, research staff will inform clinical staff at the study site if a potential participant is currently suicidal. * Participants who report transient suicidal ideation but no intent or plan will be eligible to participate. * As noted, individuals with schizophrenia and/or who are mentally incompetent to consent for participation will be excluded. Finally, participants who live outside the study catchment area (i.e., a 45 mile radius of the VA Ann Arbor Healthcare System) will be excluded.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Conflict Tactics Scale-Structured Interview (CTS-SI) | % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data | 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). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percent Change in the Percentage of Days of Substance Use for Each Substance | % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data | 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. |
Countries
United States
Participant flow
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.
Participants by arm
| Arm | Count |
|---|---|
| Arm 1: MI-CBT 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 | 60 |
| Arm 2: MI-CBT+CC 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 | 60 |
| Arm 3: E-TAU E-TAU (enhanced treatment as usual - includes brief session and provision of resources)
E-TAU: Enhanced Treatment as Usual | 60 |
| Total | 180 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 |
|---|---|---|---|---|
| Overall Study | Death | 1 | 2 | 1 |
| Overall Study | Lost to Follow-up | 2 | 4 | 3 |
| Overall Study | missing data on primary outcome | 3 | 1 | 3 |
| Overall Study | Withdrawal by Subject | 10 | 8 | 4 |
Baseline characteristics
| Characteristic | Arm 1: MI-CBT | Total | Arm 3: E-TAU | Arm 2: MI-CBT+CC |
|---|---|---|---|---|
| Age, Continuous | 39.9 years STANDARD_DEVIATION 12.9 | 42.6 years STANDARD_DEVIATION 13 | 42.9 years STANDARD_DEVIATION 12.8 | 44.9 years STANDARD_DEVIATION 12.9 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 2 Participants | 6 Participants | 2 Participants | 2 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 55 Participants | 167 Participants | 57 Participants | 55 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 3 Participants | 7 Participants | 1 Participants | 3 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 1 Participants | 0 Participants | 1 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 14 Participants | 51 Participants | 19 Participants | 18 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 5 Participants | 14 Participants | 3 Participants | 6 Participants |
| Race (NIH/OMB) White | 41 Participants | 114 Participants | 38 Participants | 35 Participants |
| Region of Enrollment United States | 60 Participants | 180 Participants | 60 Participants | 60 Participants |
| Sex: Female, Male Female | 5 Participants | 15 Participants | 5 Participants | 5 Participants |
| Sex: Female, Male Male | 55 Participants | 165 Participants | 55 Participants | 55 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk |
|---|---|---|---|
| deaths Total, all-cause mortality | 1 / 60 | 2 / 60 | 1 / 60 |
| other Total, other adverse events | 0 / 60 | 0 / 60 | 0 / 60 |
| serious Total, serious adverse events | 1 / 60 | 2 / 60 | 1 / 60 |
Outcome results
Primary
Conflict Tactics Scale-Structured Interview (CTS-SI)
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
Population: Main analyses used General Estimating Equations which accounts for missing data. Results in tables below are from bivariate analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: MI-CBT | Conflict Tactics Scale-Structured Interview (CTS-SI) | Nonpartner physical aggresion % change from baseli | -88 percentage change |
| Arm 1: MI-CBT | Conflict Tactics Scale-Structured Interview (CTS-SI) | Overall Injury Perpetration % change from baseline | -82 percentage change |
| Arm 1: MI-CBT | Conflict Tactics Scale-Structured Interview (CTS-SI) | Nonpartner injury % change from baseline | -76 percentage change |
| Arm 1: MI-CBT | Conflict Tactics Scale-Structured Interview (CTS-SI) | Partner physical aggression % change from baseline | -92 percentage change |
| Arm 1: MI-CBT | Conflict Tactics Scale-Structured Interview (CTS-SI) | Partner injury % change from baseline | -100 percentage change |
| Arm 1: MI-CBT | Conflict Tactics Scale-Structured Interview (CTS-SI) | Overall physical aggression % change from baseline | -90 percentage change |
| Arm 2: MI-CBT+CC | Conflict Tactics Scale-Structured Interview (CTS-SI) | Overall physical aggression % change from baseline | -90 percentage change |
| Arm 2: MI-CBT+CC | Conflict Tactics Scale-Structured Interview (CTS-SI) | Nonpartner physical aggresion % change from baseli | -89 percentage change |
| Arm 2: MI-CBT+CC | Conflict Tactics Scale-Structured Interview (CTS-SI) | Partner injury % change from baseline | -85 percentage change |
| Arm 2: MI-CBT+CC | Conflict Tactics Scale-Structured Interview (CTS-SI) | Partner physical aggression % change from baseline | -91 percentage change |
| Arm 2: MI-CBT+CC | Conflict Tactics Scale-Structured Interview (CTS-SI) | Nonpartner injury % change from baseline | -93 percentage change |
| Arm 2: MI-CBT+CC | Conflict Tactics Scale-Structured Interview (CTS-SI) | Overall Injury Perpetration % change from baseline | -91 percentage change |
| Arm 3: E-TAU | Conflict Tactics Scale-Structured Interview (CTS-SI) | Nonpartner injury % change from baseline | -99 percentage change |
| Arm 3: E-TAU | Conflict Tactics Scale-Structured Interview (CTS-SI) | Overall physical aggression % change from baseline | -94 percentage change |
| Arm 3: E-TAU | Conflict Tactics Scale-Structured Interview (CTS-SI) | Overall Injury Perpetration % change from baseline | -86 percentage change |
| Arm 3: E-TAU | Conflict Tactics Scale-Structured Interview (CTS-SI) | Partner injury % change from baseline | -61 percentage change |
| Arm 3: E-TAU | Conflict Tactics Scale-Structured Interview (CTS-SI) | Nonpartner physical aggresion % change from baseli | -90 percentage change |
| Arm 3: E-TAU | Conflict Tactics Scale-Structured Interview (CTS-SI) | Partner physical aggression % change from baseline | -97 percentage change |
Comparison: 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 baselinep-value: <0.00195% CI: [0.37, 1.84]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0195% CI: [0.3, 1.29]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0195% CI: [0.36, 3.77]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0595% CI: [0.19, 1.38]Wilcoxon Z
Comparison: 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 baselinep-value: <0.00195% CI: [0.66, 2.28]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0595% CI: [0.32, 1.98]Wilcoxon Z
Comparison: 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 baselinep-value: <0.00195% CI: [0.25, 1.46]Wilcoxon Z
Comparison: 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 baselinep-value: <0.00195% CI: [0.45, 2.44]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0195% CI: [0.13, 1.78]Wilcoxon Z
Comparison: 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 baselinep-value: >0.0595% CI: [0.16, 1.47]Wilcoxon Z
Comparison: 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 baselinep-value: <0.00195% CI: [0.6, 2.08]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0195% CI: [0.4, 2.95]Wilcoxon Z
Comparison: 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 baselinep-value: <0.001Wilcoxon Z
Comparison: 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 baselinep-value: <0.01Wilcoxon Z
Comparison: 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 baselinep-value: <0.01Wilcoxon Z
Comparison: 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 baselinep-value: >0.05Wilcoxon Z
Comparison: 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 baselinep-value: <0.01Wilcoxon Z
Comparison: 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 baselinep-value: <0.01Wilcoxon Z
Secondary
Percent Change in the Percentage of Days of Substance Use for Each Substance
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
Population: Main analyses used General Estimating Equations which accounts for missing data. Results in data table are from bivariate analyses.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Arm 1: MI-CBT | Percent Change in the Percentage of Days of Substance Use for Each Substance | Heavy Drinking % change from baseline | -68 percentage of change |
| Arm 1: MI-CBT | Percent Change in the Percentage of Days of Substance Use for Each Substance | cocaine use % change from baseline | -83 percentage of change |
| Arm 1: MI-CBT | Percent Change in the Percentage of Days of Substance Use for Each Substance | marijuana use % change from baseline | -40 percentage of change |
| Arm 1: MI-CBT | Percent Change in the Percentage of Days of Substance Use for Each Substance | Overall illicit drug use % change from baseline | -52 percentage of change |
| Arm 2: MI-CBT+CC | Percent Change in the Percentage of Days of Substance Use for Each Substance | Overall illicit drug use % change from baseline | -50 percentage of change |
| Arm 2: MI-CBT+CC | Percent Change in the Percentage of Days of Substance Use for Each Substance | Heavy Drinking % change from baseline | -59 percentage of change |
| Arm 2: MI-CBT+CC | Percent Change in the Percentage of Days of Substance Use for Each Substance | marijuana use % change from baseline | -42 percentage of change |
| Arm 2: MI-CBT+CC | Percent Change in the Percentage of Days of Substance Use for Each Substance | cocaine use % change from baseline | -86 percentage of change |
| Arm 3: E-TAU | Percent Change in the Percentage of Days of Substance Use for Each Substance | Overall illicit drug use % change from baseline | -57 percentage of change |
| Arm 3: E-TAU | Percent Change in the Percentage of Days of Substance Use for Each Substance | cocaine use % change from baseline | -56 percentage of change |
| Arm 3: E-TAU | Percent Change in the Percentage of Days of Substance Use for Each Substance | marijuana use % change from baseline | -44 percentage of change |
| Arm 3: E-TAU | Percent Change in the Percentage of Days of Substance Use for Each Substance | Heavy Drinking % change from baseline | -55 percentage of change |
Comparison: 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 baselinep-value: <0.00195% CI: [0.62, 1.47]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0195% CI: [0.18, 1.32]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0595% CI: [0.4, 1.8]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0595% CI: [0.54, 1.32]Wilcoxon Z
Comparison: 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 baselinep-value: <0.00195% CI: [0.78, 1.71]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0595% CI: [0.17, 2.16]Wilcoxon Z
Comparison: 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 baselinep-value: <0.0195% CI: [0.57, 2.44]Wilcoxon Z
Comparison: 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 baselinep-value: <0.00195% CI: [0.61, 1.48]Wilcoxon Z
Comparison: 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 baselinep-value: <0.001Wilcoxon Z
Comparison: 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 baselinep-value: >0.05Wilcoxon Z
Comparison: 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 baselinep-value: >0.05Wilcoxon Z
Comparison: 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 baselinep-value: <0.05Wilcoxon Z