NCT01135420

Brief Summary

This research program will improve the care and treatment outcomes of dually diagnosed veterans who receive inpatient psychiatry care, and decrease their use of VA inpatient mental health services. It will increase the use of substance abuse outpatient care and 12-step groups to benefit recovery, reduce rehospitalizations, and reduce costs for VA.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
406

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Apr 2011

Typical duration for phase_2

Geographic Reach
1 country

2 active sites

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 1, 2010

Completed
1 day until next milestone

First Posted

Study publicly available on registry

June 2, 2010

Completed
10 months until next milestone

Study Start

First participant enrolled

April 1, 2011

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2015

Completed
1.6 years until next milestone

Results Posted

Study results publicly available

December 29, 2016

Completed
Last Updated

December 29, 2016

Status Verified

November 1, 2016

Enrollment Period

3.2 years

First QC Date

June 1, 2010

Results QC Date

July 21, 2015

Last Update Submit

November 2, 2016

Conditions

Diagnosis, Dual (Psychiatry)

Outcome Measures

Primary Outcomes (1)

  • Readiness to Attend Substance Use Disorder Continuing Care

    Readiness to attend substance use disorder continuing care; scale range=0-4, with 0=not ready to do; 4=already doing; higher scores indicate a better outcome.

    3 months post-intervention

Study Arms (2)

Usual Care

ACTIVE COMPARATOR

Psychiatry inpatient usual care

Other: Usual care

Telephone Monitoring

EXPERIMENTAL

Patients in the TM condition will receive an in-person session while in treatment, followed by monitoring over the telephone for three months after discharge. The intervention will incorporate motivational interviewing to monitor patients' substance use, facilitate entry into outpatient treatment, and encourage 12-step self-help group participation.

Behavioral: Telephone Monitoring (TM) with Motivational Interviewing

Interventions

Telephone Monitoring (TM) with Motivational InterviewingBEHAVIORAL

Patients in the TM condition will receive an in-person session while in the inpatient psychiatry program, followed by monitoring delivered over the telephone for three months after discharge. The TM intervention will have a motivational interviewing component to address patients' motivation to obtain help for and reduce their substance abuse. The purpose of the intervention condition is to monitor patients' substance use, facilitate patients' entry into outpatient substance use disorder (SUD) treatment, and encourage ongoing 12-step selfhelp group participation to support sobriety.

Telephone Monitoring
Usual careOTHER

All patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study).

Usual Care

Eligibility Criteria

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

You may qualify if:

  • Dually diagnosed veteran in VA inpatient psychiatry treatment

You may not qualify if:

  • Current diagnosis of schizophrenia or schizoaffective disorder
  • too psychiatrically unstable or cognitively impaired to understand informed consent and other study procedures
  • does not have ongoing telephone access

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

VA Palo Alto Health Care System, Palo Alto, CA

Palo Alto, California, 94304-1290, United States

Location

VA Ann Arbor Healthcare System, Ann Arbor, MI

Ann Arbor, Michigan, 48105, United States

Location

Related Publications (3)

  • Timko C, Cronkite RC, McKellar J, Zemore S, Moos RH. Dually diagnosed patients' benefits of mutual-help groups and the role of social anxiety. J Subst Abuse Treat. 2013 Feb;44(2):216-23. doi: 10.1016/j.jsat.2012.05.007. Epub 2012 Jul 3.

    PMID: 22763197RESULT

  • Timko C, Bonn-Miller MO, McKellar JD, Ilgen MA. Detoxification history and two-year outcomes of substance use disorder treatment and mutual-help group participation. Journal of drug issues. 2014 Jan 1; 44(1):4-21.

    RESULT

  • Woodhead E, Cowden Hindash A, Timko C. Dual Diagnosis, Mutual-Help Use, and Outcomes: A Naturalistic Follow-Up. Journal of Dual Diagnosis. 2013 May 3; 9(2):158-164.

    RESULT

MeSH Terms

Conditions

Disease

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Results Point of Contact

Title
Christine Timko
Organization
Department of Veterans Afairs
Christine.Timko@va.gov
650-493-5000

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
RANDOMIZED
Masking
NONE
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
FED
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 1, 2010

First Posted

June 2, 2010

Study Start

April 1, 2011

Primary Completion

June 1, 2014

Study Completion

June 1, 2015

Last Updated

December 29, 2016

Results First Posted

December 29, 2016

Record last verified: 2016-11

Locations

US(2)