Study Focusing on Integrated Versus Non-integrated Psychiatric Care inNCT00787735
Improving Delivery of Mental Health Services for Patients With Drug Use and Other Behavioral and Emotional Problems
A study testing Counseling compliance in people with Study Focusing on Integrated Versus Non-integrated Psychiatric Care in and Opioid-dependent and Methadone Treated Patients With Other Psychiatric, run by Johns Hopkins University at 1 site in United States.
Trial summary
This research is being done to: identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems, learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as… Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Study Focusing on Integrated Versus Non-integrated Psychiatric Care in, Opioid-dependent and Methadone Treated Patients With Other Psychiatric, Diagnoses
- What is being tested?
- Counseling compliance
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 380 participants
- Where
- 1 siteUnited States
- Study dates
- Jan 2004to Jun 2009
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- DSM-IV criteria for current opioid physical dependence
- SAMSA Center for Substance Abuse Treatment - CSAT guidelines for maintenance on methadone or another approved opioid agonist
- have a current DSM-IV psychiatric disorder that is eligible for reimbursement in the Health Choice, Public Mental Health System (e.g., schizophrenia, mood disorders, anxiety disorders, personality disorders, adjustment disorder)
- express an interest in receiving psychiatric treatment for the problem.
Who cannot join
- pregnant
- acute medical problem that requires immediate and intense management (e.g., AIDS defining illness, tuberculosis, other serious and unstable medical disorder)
- delirium, dementia or mental retardation
- already receiving standard outpatient psychiatric care
Trial locations and contacts
1 site in 1 country.
United States1 site
Addiction Treatment Services
Baltimore, Maryland, 21224
About this study
Official title: Services Research: Psychiatric Comorbidity in Drug Abuse
This research is being done to:
- identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems,
- learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.
Read the detailed description
This study will rigorously and systematically evaluate an integrated service delivery approach using a design that reduces many of the methodological limitations in earlier work. Study participants will include opioid abusers with a current psychiatric disorder. All study participants will receive comprehensive drug abuse treatment that includes adequate daily doses of methadone. Study participants will be randomly assigned to either an onsite and fully Integrated Substance Abuse and Psychiatric Care condition (ISAP-Integrated) or an offsite and non-integrated Parallel Substance Abuse and Psychiatric Care condition (PSAP-Parallel). Patients assigned to the ISAP condition will receive all of their ambulatory psychiatric care in the ATS treatment program; those assigned to the PSAP condition will be referred for matched "doses" of psychiatric care to the Community Psychiatry Program, which is located on the same campus as the ATS program. All drug abuse treatment services will be provided in the ATS program. Patients will be evaluated for 12 months on a range of outcome measures, including psychiatric medication and therapy adherence, drug abuse treatment adherence, changes in psychiatric symptoms, including posttraumatic stress disorder (PTSD), drug use, exposure to traumatic events, psychosocial functioning, and retention in both psychiatric and drug abuse treatment.
- Conditions
- Study Focusing on Integrated Versus Non-integrated Psychiatric Care in, Opioid-dependent and Methadone Treated Patients With Other Psychiatric, Diagnoses
- Being tested
- Counseling compliance
- Medical subject headings
- Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Counseling complianceBehavioural
Rates of attendance to call counseling session over specific time points
| Study group | Role | What they receive |
|---|---|---|
| Integrated Care | Experimental | Integrated Substance Abuse and Psychiatric Care (ISAP). Subjects received both their substance abuse and psychiatric care within the ATS clinic. Counseling compliance will be measured over time. Receives: Behavioral: Counseling compliance |
| Parallel Care | Active comparator | Parallel Substance Abuse and Psychiatric Care (PSAP). Subjects received their substance abuse treatment at the ATS clinic. Their psychiatric care was received at Community Psychiatry. Counseling compliance will be measured over time. Receives: Behavioral: Counseling compliance |
What is being measured
The primary outcome is the main question the study is designed to answer.
Days to first psychiatric appointment
Measured: within first 90 days of randomized care
Overall psychiatric counseling attendance compliance rate
Includes attendance to all of the following sessions: psychiatrist, individual psychiatric counseling, and group psychiatric counseling.
Measured: 90, 180, and up to 365 days
Psychiatrist session attendance compliance rate
Measured: 90, 180, and up to 365 days
Individual and group psychiatric session attendance compliance rate
Measured: 90, 180, and up to 365 days
Secondary outcomes (2)
Level of psychiatric distress
Measured monthly using the Symptom Checklist 90-Revised (SCL90)
Measured: 90, 180, and up to 365 days
Urinalysis results
Urinalysis tests are collected weekly. Results include tests for opioids, cocaine, benzodiazepines, and cannabis.
Measured: 90, 180, and up to 365 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2008 (estimated)
- Study startJan 2004
- Primary completionJun 2009
- Study completionJun 2009
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 Study Focusing on Integrated Versus Non-integrated Psychiatric Care inStudies of the same condition, open and under way.
- More trials run by Johns Hopkins UniversityThe 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
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 380 participants (actual)
Sponsor and investigators
- Lead sponsor
- Johns Hopkins University
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Responsible party
- Principal investigator, Robert Brooner, Johns Hopkins University
- Investigators
- Robert K Brooner, Ph.D., Principal investigator, Johns Hopkins University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00787735
- Sponsor's protocol ID
- R01DA016375
- Other IDs
- R01DA016375
- Status last verified
- Mar 2017
- First submitted
- 6 Nov 2008
- Last updated
- 6 Mar 2017
- Results posted
- No
- Data monitoring committee
- No
Publications
King VL, Brooner RK, Peirce J, Kolodner K, Kidorf M. Challenges and outcomes of parallel care for patients with co-occurring psychiatric disorder in methadone maintenance treatment. J Dual Diagn. 2014;10(2):60-7. doi: 10.1080/15504263.2014.906132.
PubMed 24976801
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Services Research: Psychiatric Comorbidity in Drug Abuse
- ClinicalTrials.gov ID
- NCT00787735
- Acronym / sponsor ID
- R01DA016375
- Conditions
- Study Focusing on Integrated Versus Non-integrated Psychiatric Care in, Opioid-dependent and Methadone Treated Patients With Other Psychiatric, Diagnoses
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 380 participants (actual)
- Lead sponsor
- Johns Hopkins UniversityUniversity, hospital or other
- Collaborators
- National Institute on Drug Abuse (NIDA)
- Study start
- Jan 2004
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 7 Nov 2008 (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.
This research is being done to:
- identify any emotional, behavioral or other troubling psychological problems that some people have who are seeking and receiving treatment for heroin or other drug use problems,
- learn if providing additional psychiatric treatment services in the ATS drug abuse treatment program is as beneficial for and acceptable to patients as referring them to the Bayview Community Psychiatry Program to get help for their emotional, behavioral and other psychological problems.
Detailed description
This study will rigorously and systematically evaluate an integrated service delivery approach using a design that reduces many of the methodological limitations in earlier work. Study participants will include opioid abusers with a current psychiatric disorder. All study participants will receive comprehensive drug abuse treatment that includes adequate daily doses of methadone. Study participants will be randomly assigned to either an onsite and fully Integrated Substance Abuse and Psychiatric Care condition (ISAP-Integrated) or an offsite and non-integrated Parallel Substance Abuse and Psychiatric Care condition (PSAP-Parallel). Patients assigned to the ISAP condition will receive all of their ambulatory psychiatric care in the ATS treatment program; those assigned to the PSAP condition will be referred for matched "doses" of psychiatric care to the Community Psychiatry Program, which is located on the same campus as the ATS program. All drug abuse treatment services will be provided in the ATS program. Patients will be evaluated for 12 months on a range of outcome measures, including psychiatric medication and therapy adherence, drug abuse treatment adherence, changes in psychiatric symptoms, including posttraumatic stress disorder (PTSD), drug use, exposure to traumatic events, psychosocial functioning, and retention in both psychiatric and drug abuse treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Integrated Care | Experimental | Behavioral: Counseling complianceIntegrated Substance Abuse and Psychiatric Care (ISAP). Subjects received both their substance abuse and psychiatric care within the ATS clinic. Counseling compliance will be measured over time. |
| Parallel Care | Active comparator | Behavioral: Counseling complianceParallel Substance Abuse and Psychiatric Care (PSAP). Subjects received their substance abuse treatment at the ATS clinic. Their psychiatric care was received at Community Psychiatry. Counseling compliance will be measured over time. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- DSM-IV criteria for current opioid physical dependence
- SAMSA Center for Substance Abuse Treatment - CSAT guidelines for maintenance on methadone or another approved opioid agonist
- have a current DSM-IV psychiatric disorder that is eligible for reimbursement in the Health Choice, Public Mental Health System (e.g., schizophrenia, mood disorders, anxiety disorders, personality disorders, adjustment disorder)
- express an interest in receiving psychiatric treatment for the problem.
Key exclusion criteria (4 listed)
- pregnant
- acute medical problem that requires immediate and intense management (e.g., AIDS defining illness, tuberculosis, other serious and unstable medical disorder)
- delirium, dementia or mental retardation
- already receiving standard outpatient psychiatric care
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 |
|---|---|---|
| Counseling complianceRates of attendance to call counseling session over specific time points | Behavioural | Integrated Care, Parallel Care |
Primary outcome
Days to first psychiatric appointment
Time frame: within first 90 days of randomized care
Overall psychiatric counseling attendance compliance rate
Time frame: 90, 180, and up to 365 days
Includes attendance to all of the following sessions: psychiatrist, individual psychiatric counseling, and group psychiatric counseling.
Psychiatrist session attendance compliance rate
Time frame: 90, 180, and up to 365 days
Individual and group psychiatric session attendance compliance rate
Time frame: 90, 180, and up to 365 days
2 secondary outcomes
Level of psychiatric distress
Time frame: 90, 180, and up to 365 days
Urinalysis results
Time frame: 90, 180, and up to 365 days
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 6 Mar 2017.
- Derived from this study: PubMed 24976801King VL, Brooner RK, Peirce J, Kolodner K, Kidorf M. Challenges and outcomes of parallel care for patients with co-occurring psychiatric disorder in methadone maintenance treatment. J Dual Diagn. 2014;10(2):60-7. doi: 10.1080/15504263.2014.906132.
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.
Robert K Brooner, Ph.D. principal investigator
Johns Hopkins University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Counseling compliance in people with Study Focusing on Integrated Versus Non-integrated Psychiatric Care in and Opioid-dependent and Methadone Treated Patients With Other Psychiatric, run by Johns Hopkins University 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 4 inclusion and 4 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 6 Mar 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.
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?
Days to first psychiatric appointment (time frame: within first 90 days of randomized care). The study lists 4 primary outcomes in all. 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 NCT00787735, 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 6 Mar 2017.