NCT00700973

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
141

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2009

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 17, 2008

Completed
2 days until next milestone

First Posted

Study publicly available on registry

June 19, 2008

Completed
8 months until next milestone

Study Start

First participant enrolled

February 1, 2009

Completed
2.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2012

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
10 months until next milestone

Results Posted

Study results publicly available

September 11, 2014

Completed
Last Updated

April 27, 2015

Status Verified

February 1, 2014

Enrollment Period

2.9 years

First QC Date

June 17, 2008

Results QC Date

May 16, 2014

Last Update Submit

April 6, 2015

Conditions

Keywords

angerpsychotherapy, briefdiagnosis, dual

Outcome Measures

Primary Outcomes (1)

  • Addiction Severity Index Legal Composite

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

    One year post-intervention

Study Arms (2)

Arm 1

ACTIVE COMPARATOR

Substance use disorder usual care

Other: Usual care

Arm 2

EXPERIMENTAL

Interpersonal violence prevention intervention

Behavioral: Interpersonal Violence Prevention Intervention

Interventions

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

Arm 2

Substance use disorder usual care

Arm 1

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

Related Publications (4)

  • Timko C, Desai A, Blonigen DM, Moos BS, Moos RH. Driving while intoxicated among individuals initially untreated for alcohol use disorders: one- and sixteen-year follow-ups. J Stud Alcohol Drugs. 2011 Mar;72(2):173-84. doi: 10.15288/jsad.2011.72.173.

  • Blonigen DM, Timko C, Moos BS, Moos RH. Impulsivity is an independent predictor of 15-year mortality risk among individuals seeking help for alcohol-related problems. Alcohol Clin Exp Res. 2011 Nov;35(11):2082-92. doi: 10.1111/j.1530-0277.2011.01560.x. Epub 2011 Jun 1.

  • Makin-Byrd K, Cronkite RC, Timko C. The influence of abuse victimization on attendance and involvement in mutual-help groups among dually diagnosed male veterans. J Subst Abuse Treat. 2011 Jul;41(1):78-87. doi: 10.1016/j.jsat.2011.02.001. Epub 2011 Mar 10.

  • Timko C, Sutkowi A, Cronkite RC, Makin-Byrd K, Moos RH. Intensive referral to 12-step dual-focused mutual-help groups. Drug Alcohol Depend. 2011 Nov 1;118(2-3):194-201. doi: 10.1016/j.drugalcdep.2011.03.019. Epub 2011 Apr 22.

MeSH Terms

Conditions

Substance-Related DisordersDisease

Condition Hierarchy (Ancestors)

Chemically-Induced DisordersMental DisordersPathologic ProcessesPathological Conditions, Signs and Symptoms

Limitations and Caveats

A limitation of the trial (not a result or conclusion) is that high proportions of patients reported abstinence at baseline.

Results Point of Contact

Title
Christine Timko
Organization
VA Palo Alto Health Care System

Study Officials

  • Christine Timko, PhD

    VA Palo Alto Health Care System, Palo Alto, CA

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 17, 2008

First Posted

June 19, 2008

Study Start

February 1, 2009

Primary Completion

January 1, 2012

Study Completion

November 1, 2013

Last Updated

April 27, 2015

Results First Posted

September 11, 2014

Record last verified: 2014-02

Locations