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| ID | Type | Description | Link |
|---|---|---|---|
| HX000294 | Other Grant/Funding Number | VA Merit Review Grant |
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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
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.
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: MI-CBT | Experimental | MI-CBT (six sessions during acute treatment phase integrating motivational interviewing and cognitive behavioral approaches) |
|
| Arm 2: MI-CBT+CC | Experimental | MI-CBT+CC (acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention) |
|
| Arm 3: E-TAU | Active Comparator | E-TAU (enhanced treatment as usual - includes brief session and provision of resources) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MI-CBT | Behavioral | Six individual psychotherapy sessions during the acute substance use disorder treatment phase integrating motivational interviewing and cognitive behavioral approaches |
| Measure | Description | Time Frame |
|---|---|---|
| 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). | % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Stephen T. Chermack, PhD MA BA | VA Ann Arbor Healthcare System, Ann Arbor, MI | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| VA Ann Arbor Healthcare System, Ann Arbor, MI | Ann Arbor | Michigan | 48105 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27475408 | Background | Davis AK, Bonar EE, Ilgen MA, Walton MA, Perron BE, Chermack ST. Factors associated with having a medical marijuana card among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2016 Dec;63:132-6. doi: 10.1016/j.addbeh.2016.07.006. Epub 2016 Jul 8. | |
| 29072473 | Background | Bennett DC, Morris DH, Sexton MB, Bonar EE, Chermack ST. Associations between posttraumatic stress and legal charges among substance using veterans. Law Hum Behav. 2018 Apr;42(2):135-144. doi: 10.1037/lhb0000268. Epub 2017 Oct 26. |
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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 were recruited from June 2012-June 2015 from outpatient VA mental health programs (Substance Use Disorder, Substance use Disorder Intensive Outpatient, General Mental Health).
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| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | 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 |
| FG002 | Arm 3: E-TAU | E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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). | Main analyses used General Estimating Equations which accounts for missing data. Results in tables below are from bivariate analyses. | Posted | Number | percentage change | % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data |
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In the event of participant death, cause of death is unknown.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Participant Death | Social circumstances | Systematic Assessment | 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. |
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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.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Stephen Chermack, Ph.D. | VA Ann Arbor | 734 845-5046 | chermack@umich.edu |
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| ID | Term |
|---|---|
| D000374 | Aggression |
| D019966 | Substance-Related Disorders |
| D019973 | Alcohol-Related Disorders |
| ID | Term |
|---|---|
| D000096762 | Aberrant Motor Behavior in Dementia |
| D001526 | Behavioral Symptoms |
| D001519 | Behavior |
| D012919 | Social Behavior |
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| MI-CBT+CC | Behavioral | Acute phase MI-CBT intervention plus a subsequent 12-week phone based continuing care counseling intervention |
|
| E-TAU | Behavioral | Enhanced Treatment as Usual |
|
| % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data |
| 28728642 | Background | Anderson RE, Bonar EE, Walton MA, Goldstick JE, Rauch SAM, Epstein-Ngo QM, Chermack ST. A Latent Profile Analysis of Aggression and Victimization Across Relationship Types Among Veterans Who Use Substances. J Stud Alcohol Drugs. 2017 Jul;78(4):597-607. doi: 10.15288/jsad.2017.78.597. |
| 28570911 | Background | Davis AK, Bonar EE, Goldstick JE, Walton MA, Winters J, Chermack ST. Binge-drinking and non-partner aggression are associated with gambling among Veterans with recent substance use in VA outpatient treatment. Addict Behav. 2017 Nov;74:27-32. doi: 10.1016/j.addbeh.2017.05.022. Epub 2017 May 20. |
| 27636157 | Background | Buchholz KR, Bohnert KM, Sripada RK, Rauch SA, Epstein-Ngo QM, Chermack ST. Associations between PTSD and intimate partner and non-partner aggression among substance using veterans in specialty mental health. Addict Behav. 2017 Jan;64:194-199. doi: 10.1016/j.addbeh.2016.08.039. Epub 2016 Aug 31. |
| 30665608 | Result | Chermack ST, Bonar EE, Goldstick JE, Winters J, Blow FC, Friday S, Ilgen MA, Rauch SAM, Perron BE, Ngo QM, Walton MA. A randomized controlled trial for aggression and substance use involvement among Veterans: Impact of combining Motivational Interviewing, Cognitive Behavioral Treatment and telephone-based Continuing Care. J Subst Abuse Treat. 2019 Mar;98:78-88. doi: 10.1016/j.jsat.2019.01.001. Epub 2019 Jan 4. |
| Withdrawal by Subject |
|
| missing data on primary outcome |
|
| 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 |
| BG002 | Arm 3: E-TAU | E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual |
| BG003 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
| ID | Title | Description |
|---|
| OG000 | 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 |
| OG001 | 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 |
| OG002 | Arm 3: E-TAU | E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual |
|
|
|
| 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. | Main analyses used General Estimating Equations which accounts for missing data. Results in data table are from bivariate analyses. | Posted | Number | percentage of change | % difference between baseline and the collapsed 3-, 6-, and 12-month follow-up data |
|
|
|
|
| 1 |
| 60 |
| 1 |
| 60 |
| 0 |
| 60 |
| EG001 | 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 | 2 | 60 | 2 | 60 | 0 | 60 |
| EG002 | Arm 3: E-TAU | E-TAU (enhanced treatment as usual - includes brief session and provision of resources) E-TAU: Enhanced Treatment as Usual | 1 | 60 | 1 | 60 | 0 | 60 |
|
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| D064419 |
| Chemically-Induced Disorders |
| D001523 | Mental Disorders |
|
| marijuana use % change from baseline |
|
| Overall illicit drug use % change from baseline |
|
| 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 | Wilcoxon Z | Wilcoxon Z value: -2.98 | <0.01 | 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. | coefficient estimate | 0.49 | 2-Sided | 95 | 0.18 | 1.32 | E-TAU arm is the referent group | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -2.13 | <0.05 | 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. | coefficient estimate | 0.85 | 2-Sided | 95 | 0.4 | 1.8 | E-TAU arm is the referent group | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -2.48 | <0.05 | 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. | coefficient estimate | 0.84 | 2-Sided | 95 | 0.54 | 1.32 | E-TAU arm is the referent group | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -4.94 | <0.001 | 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. | coefficient estimate | 1.15 | 2-Sided | 95 | 0.78 | 1.71 | E-TAU arm is the referent group | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -2.56 | <0.05 | 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. | coefficient estimate | 0.61 | 2-Sided | 95 | 0.17 | 2.16 | E-TAU arm is the referent group | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -2.86 | <0.01 | 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. | coefficient estimate | 1.18 | 2-Sided | 95 | 0.57 | 2.44 | E-TAU arm is the referent group | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -3.51 | <0.001 | 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. | coefficient estimate | 0.95 | 2-Sided | 95 | 0.61 | 1.48 | E-TAU arm is the referent group | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -4.65 | <0.001 | 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. | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -1.45 | >0.05 | 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. | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -1.5 | >0.05 | 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. | Superiority |
| 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 | Wilcoxon Z | Wilcoxon Z value: -2.58 | <0.05 | 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. | Superiority |