Substance AbuseNCT01333280
Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders
A study testing Double Trouble in Recovery and Treatment as usual in people with Substance Abuse and Mental Disorders, run by Western Michigan University at 4 sites in United States.
Trial summary
The purpose of the study is to determine whether adding "dual focus" mutual aid groups to formal treatment for people dually diagnosed with substance abuse and mental illness is effective in improving treatment outcomes. NO VOLUNTEERS ARE ACCEPTED. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Substance Abuse, Mental Disorders
- What is being tested?
- Double Trouble in Recovery and Treatment as usual
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 352 participants
- Where
- 4 sitesUnited States
- Study dates
- Jul 2008to Apr 2014
- Phase
- Interventional
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- admission to one of the participating treatment programs
- substance abuse/dependence
- 18-65 years of age
- NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE THE PARTICIPATING TREATMENT PROGRAMS.
Who cannot join
- Inability to conduct an interview in English or participate in English- language DTR groups
- Appears intoxicated on drugs or alcohol
- Carries a diagnosis of mental retardation
- Deemed actively psychotic by the clinic's intake coordinator
- Appears unable to understand and give informed consent.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Coney Island Hospital
Brooklyn, New York, 11235
Proaction Health Alliance
Grand Rapids, Michigan, 49505
BRC
New York, New York, 10012
South Beach Psychiatric Center
New York, New York, 10305
About this study
The purpose of the study is to determine whether adding "dual focus" mutual aid groups to formal treatment for people dually diagnosed with substance abuse and mental illness is effective in improving treatment outcomes.
NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT PROGRAMS.
Read the detailed description
This study builds on two previous studies by the principal investigator, which found that participation in an established and growing "dual-focus" mutual aid model (Double Trouble in Recovery; DTR) by persons with co-occurring substance use and psychiatric disorders was associated with drug/alcohol abstinence and improved psychiatric outcomes. However, these findings are limited as they are based on studies using an observational design with existing DTR groups and a pre-post design with a historical control. This new application seeks to confirm and significantly extend this research by conducting a randomized clinical trial (RCT) of DTR at multiple treatment sites.
The specific study aims are:
- To conduct a multi-site RCT to determine the efficacy of "dual focus" 12-step mutual aid groups for persons with co-occurring substance use and mental disorders. Substance-using patients who are admitted to psychiatric outpatient clinics will be randomly assigned within each clinic to (i) DTR group participation plus standard treatment, or (ii) standard treatment as usual (wait list for DTR). The primary outcome is drug/alcohol use. The secondary outcomes are psychiatric medication adherence; quality of life; treatment retention; and traditional 12 step group participation. Major assessments will occur at baseline and 6 months later.
- To determine the therapeutic mechanisms mediating between DTR participation and behavioral outcomes. Hypothesized mediating variables will include both "common process" factors across treatments, e.g., coping, self-efficacy and social support; and factors relatively unique to mutual aid, e.g., mutual aid group processes, 12-step attitudes and spirituality.
- To determine the personal, social/environmental and treatment-related variables which predict DTR affiliation.
- To describe the development of DTR groups and the conditions needed to sustain them.
Federal substance abuse and mental health policy encourages the use of evidence-based interventions, yet rigorous evaluation data are scant for mutual aid groups. In particular, this research will lead to recommendations for improving the integration of formal treatment with mutual aid for persons with co-occurring disorders. Moreover, by conducting the proposed RCT, the study will substantially raise the standard by which mutual aid is evaluated.
- Conditions
- Substance Abuse, Mental Disorders
- Being tested
- Double Trouble in Recovery, Treatment as usual
- 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
Also called 12 Step groups
DTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness
Treatment as usualBehavioural
Receive usual treatment at the programs
| Study group | Role | What they receive |
|---|---|---|
| Double Trouble (DTR) group | Experimental | Double Trouble in Recovery groups Receives: Behavioral: Double Trouble in Recovery |
| Treatment as usual | Active comparator | Treatment as usual while on a waiting list for DTR groups Receives: Behavioral: Treatment as usual |
What is being measured
The primary outcome is the main question the study is designed to answer.
Substance abuse
Self-reported substance use and saliva toxicology for drugs
Measured: Study intake and six month follow-up
Secondary outcomes (4)
psychiatric medication adherence
Self-reported adherence to prescribed medications
Measured: six month follow-up
Traditional 12-step meeting participation
Measured: six month follow-up
Treatment retention
Measured: six month follow-up
Quality of life
Measured: six month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2011 (estimated)
- Study startJul 2008
- Primary completionNov 2012
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Substance AbuseStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 352 participants (actual)
Sponsor and investigators
- Lead sponsor
- Western Michigan University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Stephen Magura, Western Michigan University
- Investigators
- Stephen Magura, Ph.D., Principal investigator, Western Michigan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01333280
- Sponsor's protocol ID
- DUALFOCUSAID
- Other IDs
- 1R01DA023119-01A1
- Status last verified
- Dec 2014
- First submitted
- 8 Apr 2011
- Last updated
- 10 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Publications
Rosenblum A, Matusow H, Fong C, Vogel H, Uttaro T, Moore TL, Magura S. Efficacy of dual focus mutual aid for persons with mental illness and substance misuse. Drug Alcohol Depend. 2014 Feb 1;135:78-87. doi: 10.1016/j.drugalcdep.2013.11.012. Epub 2013 Nov 18.
PubMed 24342419Matusow H, Guarino H, Rosenblum A, Vogel H, Uttaro T, Khabir S, Rini M, Moore T, Magura S. Consumers' Experiences in Dual Focus Mutual Aid for Co-occurring Substance Use and Mental Health Disorders. Subst Abuse. 2013;7:39-47. doi: 10.4137/SART.S11006. Epub 2013 Mar 6.
PubMed 23515888Magura S, Mateu PF, Rosenblum A, Matusow H, Fong C. Risk factors for medication non-adherence among psychiatric patients with substance misuse histories. Ment Health Subst Use. 2014 Nov;7(4):381-390. doi: 10.1080/17523281.2013.839574.
PubMed 25309623Matusow H, Rosenblum A, Fong C, Laudet A, Uttaro T, Magura S. Factors associated with mental health clinicians' referrals to 12-Step groups. J Addict Dis. 2012;31(3):303-12. doi: 10.1080/10550887.2012.694605.
PubMed 22873191
Study at a glance
From the registry record, last updated by the sponsor on 10 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Dual Focus Mutual Aid for Persons With Co-occurring Disorders
- ClinicalTrials.gov ID
- NCT01333280
- Acronym / sponsor ID
- DUALFOCUSAID
- Conditions
- Substance Abuse, Mental Disorders
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 352 participants (actual)
- Lead sponsor
- Western Michigan UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jul 2008
- Primary completion
- Nov 2012 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 11 Apr 2011 (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 the study is to determine whether adding "dual focus" mutual aid groups to formal treatment for people dually diagnosed with substance abuse and mental illness is effective in improving treatment outcomes.
NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE PARTICIPATING TREATMENT PROGRAMS.
Detailed description
This study builds on two previous studies by the principal investigator, which found that participation in an established and growing "dual-focus" mutual aid model (Double Trouble in Recovery; DTR) by persons with co-occurring substance use and psychiatric disorders was associated with drug/alcohol abstinence and improved psychiatric outcomes. However, these findings are limited as they are based on studies using an observational design with existing DTR groups and a pre-post design with a historical control. This new application seeks to confirm and significantly extend this research by conducting a randomized clinical trial (RCT) of DTR at multiple treatment sites.
The specific study aims are:
- To conduct a multi-site RCT to determine the efficacy of "dual focus" 12-step mutual aid groups for persons with co-occurring substance use and mental disorders. Substance-using patients who are admitted to psychiatric outpatient clinics will be randomly assigned within each clinic to (i) DTR group participation plus standard treatment, or (ii) standard treatment as usual (wait list for DTR). The primary outcome is drug/alcohol use. The secondary outcomes are psychiatric medication adherence; quality of life; treatment retention; and traditional 12 step group participation. Major assessments will occur at baseline and 6 months later.
- To determine the therapeutic mechanisms mediating between DTR participation and behavioral outcomes. Hypothesized mediating variables will include both "common process" factors across treatments, e.g., coping, self-efficacy and social support; and factors relatively unique to mutual aid, e.g., mutual aid group processes, 12-step attitudes and spirituality.
- To determine the personal, social/environmental and treatment-related variables which predict DTR affiliation.
- To describe the development of DTR groups and the conditions needed to sustain them.
Federal substance abuse and mental health policy encourages the use of evidence-based interventions, yet rigorous evaluation data are scant for mutual aid groups. In particular, this research will lead to recommendations for improving the integration of formal treatment with mutual aid for persons with co-occurring disorders. Moreover, by conducting the proposed RCT, the study will substantially raise the standard by which mutual aid is evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Double Trouble (DTR) group | Experimental | Behavioral: Double Trouble in RecoveryDouble Trouble in Recovery groups |
| Treatment as usual | Active comparator | Behavioral: Treatment as usualTreatment as usual while on a waiting list for DTR groups |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- admission to one of the participating treatment programs
- substance abuse/dependence
- 18-65 years of age
- NO VOLUNTEERS ARE ACCEPTED. ENROLLMENT IS LIMITED TO CLIENTS OF THE THE PARTICIPATING TREATMENT PROGRAMS.
Key exclusion criteria (5 listed)
- Inability to conduct an interview in English or participate in English- language DTR groups
- Appears intoxicated on drugs or alcohol
- Carries a diagnosis of mental retardation
- Deemed actively psychotic by the clinic's intake coordinator
- Appears 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 RecoveryAlso: 12 Step groupsDTR is a 12 Step-based fellowship for individuals with co-occurring problems of substance abuse and mental illness | Behavioural | Double Trouble (DTR) group |
| Treatment as usualReceive usual treatment at the programs | Behavioural | Treatment as usual |
Primary outcome
Substance abuse
Time frame: Study intake and six month follow-up
Self-reported substance use and saliva toxicology for drugs
4 secondary outcomes
psychiatric medication adherence
Time frame: six month follow-up
Traditional 12-step meeting participation
Time frame: six month follow-up
Treatment retention
Time frame: six month follow-up
Quality of life
Time frame: six month follow-up
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 10 Dec 2014.
- Results publication: PubMed 24342419Rosenblum A, Matusow H, Fong C, Vogel H, Uttaro T, Moore TL, Magura S. Efficacy of dual focus mutual aid for persons with mental illness and substance misuse. Drug Alcohol Depend. 2014 Feb 1;135:78-87. doi: 10.1016/j.drugalcdep.2013.11.012. Epub 2013 Nov 18.
- Results publication: PubMed 23515888Matusow H, Guarino H, Rosenblum A, Vogel H, Uttaro T, Khabir S, Rini M, Moore T, Magura S. Consumers' Experiences in Dual Focus Mutual Aid for Co-occurring Substance Use and Mental Health Disorders. Subst Abuse. 2013;7:39-47. doi: 10.4137/SART.S11006. Epub 2013 Mar 6.
- Results publication: PubMed 25309623Magura S, Mateu PF, Rosenblum A, Matusow H, Fong C. Risk factors for medication non-adherence among psychiatric patients with substance misuse histories. Ment Health Subst Use. 2014 Nov;7(4):381-390. doi: 10.1080/17523281.2013.839574.
- Results publication: PubMed 22873191Matusow H, Rosenblum A, Fong C, Laudet A, Uttaro T, Magura S. Factors associated with mental health clinicians' referrals to 12-Step groups. J Addict Dis. 2012;31(3):303-12. doi: 10.1080/10550887.2012.694605.
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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
Western Michigan University
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Double Trouble in Recovery and Treatment as usual in people with Substance Abuse and Mental Disorders, run by Western Michigan University at 4 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 4 inclusion and 5 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 10 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 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.
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?
Substance abuse (time frame: Study intake and six month follow-up). 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 NCT01333280, 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 10 Dec 2014.