Diagnosis, Dual (Psychiatry)Phase 2NCT01135420
Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes
A Phase 2 study testing Telephone Monitoring (TM) with Motivational Interviewing in people with Diagnosis, Dual (Psychiatry), run by VA Office of Research and Development at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diagnosis, Dual (Psychiatry)
- What is being tested?
- Telephone Monitoring (TM) with Motivational Interviewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 406 participants
- Where
- 2 sitesUnited States
- Study dates
- Apr 2011to Jun 2015
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Dually diagnosed veteran in VA inpatient psychiatry treatment
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
United States2 sites
VA Ann Arbor Healthcare System, Ann Arbor, MI
Ann Arbor, Michigan, 48105
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
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.
Read the detailed description
Background:
Substance use disorders (SUDs) are highly prevalent among veteran psychiatry inpatients. Dual substance use and psychiatric disorders are related to poor outcomes and rehospitalizations, which are quite costly. However, relatively little is known about how to effectively help dually diagnosed psychiatry inpatients. Telephone Monitoring (TM) is effective among SUD patients at increasing SUD continuing care and self-help utilization and improving SUD outcomes. This study will build on these findings and contribute important new clinical knowledge by determining whether TM is similarly effective when adapted for dually diagnosed veteran psychiatry inpatients. It will evaluate the effectiveness of a manual-guided TM intervention.
Objectives:
Primary hypotheses are that patients in the TM condition, compared to patients in usual care (UC), will attend more SUD continuing care sessions and 12-step group meetings, and have better SUD and psychiatric outcomes. Secondary hypotheses are that TM patients will have fewer and delayed rehospitalizations, and their better outcomes will be mediated by SUD outpatient treatment and 12-step group participation.
Methods:
This study will take place at two VAs: Palo Alto (VISN 21) and Ann Arbor (VISN 11). Dually diagnosed patients in psychiatry inpatient treatment will be randomly assigned to UC or TM. 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 if a relapse occurs, and encourage 12-step self-help group participation. Patients will be assessed at baseline, end-of-intervention, and six months and one-year post-intervention for primary and secondary outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and TM groups on course of primary and secondary outcomes over time; Cox regression models will compare groups on time to rehospitalization; and sequential regression analyses will examine whether outcomes associated with TM are mediated by more SUD continuing care and 12-step group participation.
Status:
As of this time, this project is in the follow-up data collection phase.
- Conditions
- Diagnosis, Dual (Psychiatry)
- Being tested
- Telephone Monitoring (TM) with Motivational Interviewing, Usual care
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Telephone Monitoring (TM) with Motivational InterviewingBehavioural
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.
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).
| Study group | Role | What they receive |
|---|---|---|
| Usual Care | Active comparator | Psychiatry inpatient usual care Receives: 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. Receives: Behavioral: Telephone Monitoring (TM) with Motivational Interviewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months post-intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2010 (estimated)
- Study startApr 2011
- Primary completionJun 2014
- Study completionJun 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Diagnosis, Dual (Psychiatry)Studies of the same condition, open and under way.
- More trials run by VA Office of Research and DevelopmentThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 406 participants (actual)
Sponsor and investigators
- Lead sponsor
- VA Office of Research and Development
- Sponsor type
- US federal agency
- Responsible party
- Sponsor
- Investigators
- Christine Timko, PhD, Principal investigator, VA Palo Alto Health Care System, Palo Alto, CA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01135420
- Sponsor's protocol ID
- IAC 09-055
- Status last verified
- Nov 2016
- First submitted
- 1 Jun 2010
- Last updated
- 29 Dec 2016
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
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.
PubMed 22763197Timko 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.
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.
Study at a glance
From the registry record, last updated by the sponsor on 29 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Diagnosis Inpatients: Telephone Monitoring RCT to Improve Outcomes
- ClinicalTrials.gov ID
- NCT01135420
- Acronym / sponsor ID
- IAC 09-055
- Conditions
- Diagnosis, Dual (Psychiatry)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 406 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Apr 2011
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2015 (actual)
- First posted
- 2 Jun 2010 (estimated)
- Results
- Posted 29 Dec 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Background:
Substance use disorders (SUDs) are highly prevalent among veteran psychiatry inpatients. Dual substance use and psychiatric disorders are related to poor outcomes and rehospitalizations, which are quite costly. However, relatively little is known about how to effectively help dually diagnosed psychiatry inpatients. Telephone Monitoring (TM) is effective among SUD patients at increasing SUD continuing care and self-help utilization and improving SUD outcomes. This study will build on these findings and contribute important new clinical knowledge by determining whether TM is similarly effective when adapted for dually diagnosed veteran psychiatry inpatients. It will evaluate the effectiveness of a manual-guided TM intervention.
Objectives:
Primary hypotheses are that patients in the TM condition, compared to patients in usual care (UC), will attend more SUD continuing care sessions and 12-step group meetings, and have better SUD and psychiatric outcomes. Secondary hypotheses are that TM patients will have fewer and delayed rehospitalizations, and their better outcomes will be mediated by SUD outpatient treatment and 12-step group participation.
Methods:
This study will take place at two VAs: Palo Alto (VISN 21) and Ann Arbor (VISN 11). Dually diagnosed patients in psychiatry inpatient treatment will be randomly assigned to UC or TM. 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 if a relapse occurs, and encourage 12-step self-help group participation. Patients will be assessed at baseline, end-of-intervention, and six months and one-year post-intervention for primary and secondary outcomes and non-VA health care; VA health care will be assessed with VA databases. GLMM analyses will be conducted to compare the UC and TM groups on course of primary and secondary outcomes over time; Cox regression models will compare groups on time to rehospitalization; and sequential regression analyses will examine whether outcomes associated with TM are mediated by more SUD continuing care and 12-step group participation.
Status:
As of this time, this project is in the follow-up data collection phase.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual Care | Active comparator | Other: Usual carePsychiatry inpatient usual care |
| Telephone Monitoring | Experimental | Behavioral: Telephone Monitoring (TM) with Motivational InterviewingPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Dually diagnosed veteran in VA inpatient psychiatry treatment
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Telephone Monitoring (TM) with Motivational InterviewingPatients 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. | Behavioural | Telephone Monitoring |
| Usual careAll patients in the trial will receive usual care (i.e., the care they would have received in the absence of a study). | Other | Usual Care |
Primary outcome
Readiness to Attend Substance Use Disorder Continuing Care
Time frame: 3 months post-intervention
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Dec 2016.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 22763197Timko 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.
- Results publicationTimko 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.
- Results publicationWoodhead 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Christine Timko, PhD principal investigator
VA Palo Alto Health Care System, Palo Alto, CA
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Telephone Monitoring (TM) with Motivational Interviewing in people with Diagnosis, Dual (Psychiatry), run by VA Office of Research and Development at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Dec 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Readiness to Attend Substance Use Disorder Continuing Care (time frame: 3 months post-intervention). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01135420, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Dec 2016.