Dual DiagnosisNCT00286728
Dual Diagnosis Self-Help Referral
A study testing Intensive referral to dual-focused self-help in people with Dual Diagnosis, run by VA Office of Research and Development at 1 site in United States.
Trial summary
This project will help counselors in substance abuse treatment programs make effective referrals of dually diagnosed patients (those with a co-occurring psychiatric disorder) to self-help groups. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Dual Diagnosis
- What is being tested?
- Intensive referral to dual-focused self-help
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 287 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2006to Sep 2010
- Phase
- Interventional
- 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 veterans entering outpatient mental health treatment
Who cannot join
- Unable to correctly answer the Orientation and Registration questions of the Mini-Mental State Examination
Trial locations and contacts
1 site in 1 country.
United States1 site
VA Palo Alto Health Care System, Palo Alto, CA
Palo Alto, California, 94304-1290
About this study
Official title: Dual Diagnosis Self-Help Group Referral: Outcomes and Services Use
This project will help counselors in substance abuse treatment programs make effective referrals of dually diagnosed patients (those with a co-occurring psychiatric disorder) to self-help groups.
Read the detailed description
Background:
Dual diagnosis (psychiatric and substance use) patients' (DDPs) participation in 12-step mutual-help groups is linked to lower relapse and treatment utilization rates. However, under usual referral, many DDPs do not attend, or sustain attendance of, substance-focused groups (SFG). DDPs may benefit from dual-focused groups (DFGs).
Objectives:
(1) Implement and validate procedures to help counselors make effective referrals to DFGs. DDPs were assigned to a standard- or intensive-referral to DFG condition to determine the extent to which intensive referral, compared to standard referral, increased patients' mutual-help group participation. (2) Determine whether DDPs who received intensive referral had better substance use and psychiatric outcomes.
Methods:
DDPs entering VA outpatient mental health treatment received either standard (N=145) or intensive (N=142) referral. Standard referral consisted essentially of the counselor recommending DFG participation. The keys to intensive referral were a DFG orientation and the counselor facilitating direct contact between the patient and a DFG member, and following up on recommendations for mutual help. Patients were followed at six months (80%), one year (81%) and two years (80%) to determine whether intensive referral resulted in more DFG and SFG participation, and better substance use and psychiatric outcomes.
Status:
Completed.
- Conditions
- Dual Diagnosis
- Being tested
- Intensive referral to dual-focused self-help
- Keywords
- self-help groups, referral and consultation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive referral to dual-focused self-helpBehavioural
4 group sessions to introduce patients to dual focused groups
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Intensive referral to dual-focused self-help groups Receives: Behavioral: Intensive referral to dual-focused self-help |
| Arm 2 | No intervention | Usual care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Psychiatric Functioning at 6 Months
Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.
Measured: 6 months
Secondary outcomes (1)
Mental Health Services Use and Costs at 6 Months, 1 Year, and 2 Years
Measured: 6 months, 1 year, 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Feb 2006 (estimated)
- Study startApr 2006
- Primary completionSep 2010
- Study completionSep 2010
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 (4)Papers the sponsor has linked to this study.
- Other trials for Dual DiagnosisStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 287 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
- NCT00286728
- Sponsor's protocol ID
- IIR 05-014
- Status last verified
- Apr 2019
- First submitted
- 1 Feb 2006
- Last updated
- 8 May 2019
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
Publications
Timko C, Sutkowi A, Moos R. Patients with dual diagnoses or substance use disorders only: 12-step group participation and 1-year outcomes. Subst Use Misuse. 2010 Mar;45(4):613-27. doi: 10.3109/10826080903452421.
PubMed 20141467Timko C. Detoxification history and two-year outcomes of substance use disorder treatment and mutual-help group participation. Journal of drug issues. 2013 Jun 17; 20(10):1-18.
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.
PubMed 21396794Timko 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 22763197
Study at a glance
From the registry record, last updated by the sponsor on 8 May 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dual Diagnosis Self-Help Group Referral: Outcomes and Services Use
- ClinicalTrials.gov ID
- NCT00286728
- Acronym / sponsor ID
- IIR 05-014
- Conditions
- Dual Diagnosis
- Keywords
- self-help groups, referral and consultation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 287 participants (actual)
- Lead sponsor
- VA Office of Research and DevelopmentUS federal agency
- Study start
- Apr 2006
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 3 Feb 2006 (estimated)
- Results
- Posted 6 Oct 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This project will help counselors in substance abuse treatment programs make effective referrals of dually diagnosed patients (those with a co-occurring psychiatric disorder) to self-help groups.
Detailed description
Background:
Dual diagnosis (psychiatric and substance use) patients' (DDPs) participation in 12-step mutual-help groups is linked to lower relapse and treatment utilization rates. However, under usual referral, many DDPs do not attend, or sustain attendance of, substance-focused groups (SFG). DDPs may benefit from dual-focused groups (DFGs).
Objectives:
(1) Implement and validate procedures to help counselors make effective referrals to DFGs. DDPs were assigned to a standard- or intensive-referral to DFG condition to determine the extent to which intensive referral, compared to standard referral, increased patients' mutual-help group participation. (2) Determine whether DDPs who received intensive referral had better substance use and psychiatric outcomes.
Methods:
DDPs entering VA outpatient mental health treatment received either standard (N=145) or intensive (N=142) referral. Standard referral consisted essentially of the counselor recommending DFG participation. The keys to intensive referral were a DFG orientation and the counselor facilitating direct contact between the patient and a DFG member, and following up on recommendations for mutual help. Patients were followed at six months (80%), one year (81%) and two years (80%) to determine whether intensive referral resulted in more DFG and SFG participation, and better substance use and psychiatric outcomes.
Status:
Completed.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Behavioral: Intensive referral to dual-focused self-helpIntensive referral to dual-focused self-help groups |
| Arm 2 | No intervention | –Usual care |
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 veterans entering outpatient mental health treatment
Key exclusion criteria (1 listed)
- Unable to correctly answer the Orientation and Registration questions of the Mini-Mental State Examination
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 |
|---|---|---|
| Intensive referral to dual-focused self-help4 group sessions to introduce patients to dual focused groups | Behavioural | Arm 1 |
Primary outcome
Psychiatric Functioning at 6 Months
Time frame: 6 months
Addiction Severity Index psychiatric composite ranges from 0 to 1, with 1 indicating more severe problems.
1 secondary outcome
Mental Health Services Use and Costs at 6 Months, 1 Year, and 2 Years
Time frame: 6 months, 1 year, 2 years
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 May 2019.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Results publication: PubMed 20141467Timko C, Sutkowi A, Moos R. Patients with dual diagnoses or substance use disorders only: 12-step group participation and 1-year outcomes. Subst Use Misuse. 2010 Mar;45(4):613-27. doi: 10.3109/10826080903452421.
- Results publicationTimko C. Detoxification history and two-year outcomes of substance use disorder treatment and mutual-help group participation. Journal of drug issues. 2013 Jun 17; 20(10):1-18.
- Results publication: PubMed 21396794Makin-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.
- 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.
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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
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive referral to dual-focused self-help in people with Dual Diagnosis, run by VA Office of Research and Development at 1 site 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 1 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 8 May 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 6 Oct 2014). 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?
Psychiatric Functioning at 6 Months (time frame: 6 months). 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 NCT00286728, which also lists 4 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 8 May 2019.