Dual DiagnosisPhase 1/2NCT00218582
Effectiveness of Self-Help for Dually-Diagnosed Persons - 1
A Phase 1/2 study testing Double Trouble in Recovery and Standard psychiatric day treatment in people with Dual Diagnosis and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) at 1 site in United States.
Trial summary
The purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders. Read more about this study
- Who is it for?
- Ages 18 to 64 years
- Conditions the study is for
- Dual Diagnosis, Substance-Related Disorders, Mental Disorders
- What is being tested?
- Double Trouble in Recovery and Standard psychiatric day treatment
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 229 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Mar 2007
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
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 to 64 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Admission to psychiatric day treatment program 18-64 years old
Who cannot join
- Did not understand or speak English, appeared intoxicated on drugs or alcohol, carried a diagnosis of mental retardation, were deemed actively psychotic by the clinic's intake coordinator, appeared unable to understand and give informed consent.
Trial locations and contacts
1 site in 1 country.
United States1 site
Albert Einstein Dept of Psychiatry
The Bronx, New York, 10461
About this study
Official title: Effectiveness of Self-Help for Dually-Diagnosed Persons
The purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders.
- Being tested
- Double Trouble in Recovery, Standard psychiatric day treatment
- Keywords
- 12 step groups, self help, psychiatric day treatment, co-occurring disorders, dual diagnosis
- Medical subject headings
- Substance-Related Disorders, Mental Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Double Trouble in RecoveryBehavioural
Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment
Standard psychiatric day treatmentBehavioural
Individual counseling, groups, medication
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Dual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment Receives: Behavioral: Double Trouble in Recovery |
| 2 | Active comparator | Standard psychiatric day treatment Receives: Behavioral: Standard psychiatric day treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
drug/alcohol use
Measured: past 90 days
Secondary outcomes (4)
psychiatric medication adherence
Measured: recent
traditional 12 step meeting attendance
Measured: past 90 days
psychiatric symptoms
Measured: recent
program retention
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Sep 2005 (estimated)
- Study startMar 2003
- Primary completionMar 2007
- Study completionMar 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dual DiagnosisStudies of the same condition, open and under way.
- 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 1/2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 229 participants (actual)
Sponsor and investigators
- Lead sponsor
- National Institute on Drug Abuse (NIDA)
- Sponsor type
- US National Institutes of Health
- Collaborators
- National Development and Research Institutes, Inc.
- Investigators
- Stephen Magura, Ph.D., Principal investigator, National Development and Research Institutes, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00218582
- Sponsor's protocol ID
- NIDA-15912-1
- Other IDs
- R01-15912-1
- Status last verified
- Oct 2008
- First submitted
- 20 Sep 2005
- Last updated
- 12 Jan 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
Magura S, Rosenblum A, Villano CL, Vogel HS, Fong C, Betzler T. Dual-focus mutual aid for co-occurring disorders: a quasi-experimental outcome evaluation study. Am J Drug Alcohol Abuse. 2008;34(1):61-74. doi: 10.1080/00952990701764623.
PubMed 18161644
Study at a glance
From the registry record, last updated by the sponsor on 12 Jan 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of Self-Help for Dually-Diagnosed Persons
- ClinicalTrials.gov ID
- NCT00218582
- Acronym / sponsor ID
- NIDA-15912-1
- Keywords
- 12 step groups, self help, psychiatric day treatment, co-occurring disorders, dual diagnosis
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 229 participants (actual)
- Lead sponsor
- National Institute on Drug Abuse (NIDA)US National Institutes of Health
- Collaborators
- National Development and Research Institutes, Inc.
- Study start
- Mar 2003
- Primary completion
- Mar 2007 (actual)
- Study completion
- Mar 2007 (actual)
- First posted
- 22 Sep 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine the effectiveness of adding dual focus 12-step self-help groups to standard treatment to improve behavioral outcomes for patients dually diagnosed with substance abuse and psychiatric disorders.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Double Trouble in RecoveryDual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment |
| 2 | Active comparator | Behavioral: Standard psychiatric day treatmentStandard psychiatric day treatment |
Who may qualify
- Ages
- 18 to 64 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Admission to psychiatric day treatment program 18-64 years old
Key exclusion criteria (1 listed)
- Did not understand or speak English, appeared intoxicated on drugs or alcohol, carried a diagnosis of mental retardation, were deemed actively psychotic by the clinic's intake coordinator, appeared unable to understand and give informed consent.
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 |
|---|---|---|
| Double Trouble in RecoveryDual focus 12 step mutual aid groups for persons with co-occurring disorders (psychiatric and substance use disorders), provided within the context of standard psychiatric day treatment | Behavioural | 1 |
| Standard psychiatric day treatmentIndividual counseling, groups, medication | Behavioural | 2 |
Primary outcome
drug/alcohol use
Time frame: past 90 days
4 secondary outcomes
psychiatric medication adherence
Time frame: recent
traditional 12 step meeting attendance
Time frame: past 90 days
psychiatric symptoms
Time frame: recent
program retention
Time frame: up to 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jan 2017.
- Results publication: PubMed 18161644Magura S, Rosenblum A, Villano CL, Vogel HS, Fong C, Betzler T. Dual-focus mutual aid for co-occurring disorders: a quasi-experimental outcome evaluation study. Am J Drug Alcohol Abuse. 2008;34(1):61-74. doi: 10.1080/00952990701764623.
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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.
Stephen Magura, Ph.D. principal investigator
National Development and Research Institutes, Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Double Trouble in Recovery and Standard psychiatric day treatment in people with Dual Diagnosis and Substance-Related Disorders, run by National Institute on Drug Abuse (NIDA) 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 12 Jan 2017. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
drug/alcohol use (time frame: past 90 days). 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 NCT00218582, which also lists 1 linked publication.
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 12 Jan 2017; AzTrials last refreshed its copy on 6 Nov 2026.