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Treating Violence-Prone Substance Use Disorder Patients

Treating Violence-Prone Substance Use Disorder Patients

Status
Completed
Phases
Phase 2Phase 3
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00700973
Enrollment
141
Registered
2008-06-19
Start date
2009-02-28
Completion date
2013-11-30
Last updated
2015-04-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Substance-related Disorders, Violence

Keywords

anger, psychotherapy, brief, diagnosis, dual

Brief summary

This project is intended to help substance use disorder patients who perpetrate interpersonal violence against other adults.

Detailed description

Background: Interpersonal violence (IPV) among substance use disorder (SUD) patients is common, undertreated, and costly. SUD patients have high rates of perpetrating IPV, and IPV is a risk factor for poor response to SUD treatment. Failure to address IPV among SUD patients interferes with treatment effectiveness and contributes to relapse and higher rates of health services use. Nonetheless, SUD treatment programs typically do not include violence prevention interventions and few studies have examined interventions designed to prevent violence perpetration among SUD patients. Objectives: This trial evaluated the effectiveness of an IPV-prevention (IPV-P) intervention among patients entering VA SUD treatment who had perpetrated violence in the past year against another adult. Primary objectives were to test the hypotheses that, compared to patients assigned to a control condition (CC), those assigned to IPV-P would (1) improve more on violence and SUD outcomes, and (2) use fewer VA mental health and medical care services, thereby saving costs for VA. Secondary objectives were to test the hypothesis that, compared to patients assigned to CC, those assigned to IPV-P would improve more on legal and alienation problems and social resources. Methods: Patients entering VA SUD treatment who met eligibility criteria (past-year violence; cognitively intact) and provided informed consent were assigned to SUD usual care plus either a CC (N=60) or IPV-P (N=59) intervention using a recurrent institutional design. That is, the IPV-P and CC conditions were run in alternate 3-month periods. The manualized IPV-P group intervention, based on a Cognitive-Behavioral approach, consisted of 8 in-person group sessions over 1 month, followed by telephone calls once a month for 3 months. The manualized CC was designed to control for non-specific treatment effects associated with the IPV-P condition, i.e., counselor time and attention, peer support, patients' expectations that additional sessions provide benefit. It consisted of 8 in-person group sessions over 1 month that reviewed material covered in usual SUD treatment, but with novel methods used to deliver the IPV-P intervention (role-play, homework, group activities). CC included the booster telephone sessions (once per month for 3 months). Participants were assessed at baseline and end-of-intervention (4 months post-baseline) and 6 and 12 months post-intervention (i.e., 10 and 16 months post-baseline) for primary and secondary outcomes and non-VA healthcare. Assessments consisted of the Addiction Severity Index (ASI, to assess Alcohol, Drugs, Psychiatric, and Legal functioning), the Conflicts Tactics Scale (CTS, to assess Psychological Aggression and Physical Assault against another adult), the Multidimensional Personality Questionnaire (MDQ, to assess Alienation, Stress Reaction, and Aggression), and the Life Stressors and Social Resources Inventory (LISRES, to assess family and friends resources). VA health care is being assessed with VA databases. Response rates at 4, 10, and 16 months were 90%, 79%, and 73%, respectively, and did not differ between the IPV-P and CC groups. Follow-up analyses compared the IPV-P to the CC group on outcomes using analyses of covariance that controlled for the baseline value of the outcome. Status: We are still completing portions of this project: (1) conducting mixed effects regression analyses to compare the CC and IPV-P groups on primary and secondary outcomes (these analyses are partially completed), and (2) using data on VA health care utilization to compare the two groups on VA health care costs (permission to download these data has been obtained, and we are working with HERC investigators to download and analyze the data).

Interventions

BEHAVIORALInterpersonal Violence Prevention Intervention

This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change.

OTHERUsual care

Substance use disorder usual care

Sponsors

US Department of Veterans Affairs
Lead SponsorFED

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

* Entering VA substance use disorder treatment * past-year violence * cognitively intact

Exclusion criteria

* Not entering VA substance use disorder treatment * no past-year violence * cognitively not intact

Design outcomes

Primary

MeasureTime frameDescription
Addiction Severity Index Legal CompositeOne year post-interventionScores range from 0 to 1, with higher scores indicating more severe legal problems.

Countries

United States

Participant flow

Participants by arm

ArmCount
Arm 1
Substance use disorder usual care Usual care: Substance use disorder usual care
71
Arm 2
Interpersonal violence prevention intervention Interpersonal Violence Prevention Intervention: This is a cognitive-behavioral approach incorporating cognitive restructuring and behavioral change.
70
Total141

Baseline characteristics

CharacteristicArm 1Arm 2Total
Age, Continuous52 years
STANDARD_DEVIATION 8
51 years
STANDARD_DEVIATION 8
52 years
STANDARD_DEVIATION 8
Race/Ethnicity, Customized
Non-White
37 participants36 participants73 participants
Race/Ethnicity, Customized
White
34 participants34 participants68 participants
Region of Enrollment
United States
71 participants70 participants141 participants
Sex: Female, Male
Female
0 Participants0 Participants0 Participants
Sex: Female, Male
Male
71 Participants70 Participants141 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
deaths
Total, all-cause mortality
— / —— / —
other
Total, other adverse events
0 / 710 / 70
serious
Total, serious adverse events
0 / 710 / 70

Outcome results

Primary

Addiction Severity Index Legal Composite

Scores range from 0 to 1, with higher scores indicating more severe legal problems.

Time frame: One year post-intervention

ArmMeasureValue (MEAN)Dispersion
Arm 1Addiction Severity Index Legal Composite.038 units on a scaleStandard Deviation 0.049
Arm 2Addiction Severity Index Legal Composite.012 units on a scaleStandard Deviation 0.049

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026