Improving Delivery of Mental Health Services for Patients With Drug Use and Other Behavioral and Emotional Problems

This study has been completed.
Sponsor:
Collaborator:
Information provided by (Responsible Party):
Robert Brooner, Johns Hopkins University
ClinicalTrials.gov Identifier:
NCT00787735
First received: November 6, 2008
Last updated: March 8, 2013
Last verified: March 2013
  Purpose

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.

Condition Intervention
Study Focusing on Integrated Versus Non-integrated Psychiatric Care in
Opioid-dependent and Methadone Treated Patients With Other Psychiatric
Diagnoses.
Behavioral: Counseling compliance

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Services Research: Psychiatric Comorbidity in Drug Abuse

Further study details as provided by Johns Hopkins University:

Primary Outcome Measures:
  • Days to first psychiatric appointment [ Time Frame: within first 90 days of randomized care ] [ Designated as safety issue: No ]
  • Overall psychiatric counseling attendance compliance rate [ Time Frame: 90, 180, and up to 365 days ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
  • Individual and group psychiatric session attendance compliance rate [ Time Frame: 90, 180, and up to 365 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Level of psychiatric distress [ Time Frame: 90, 180, and up to 365 days ] [ Designated as safety issue: No ]
    Measured monthly using the Symptom Checklist 90-Revised (SCL90)

  • Urinalysis results [ Time Frame: 90, 180, and up to 365 days ] [ Designated as safety issue: No ]
    Urinalysis tests are collected weekly. Results include tests for opioids, cocaine, benzodiazepines, and cannabis.


Enrollment: 380
Study Start Date: January 2004
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Integrated Care
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.
Behavioral: Counseling compliance
Rates of attendance to call counseling session over specific time points
Active Comparator: Parallel Care
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.
Behavioral: Counseling compliance
Rates of attendance to call counseling session over specific time points

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.

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00787735

Locations
United States, Maryland
Addiction Treatment Services
Baltimore, Maryland, United States, 21224
Sponsors and Collaborators
Johns Hopkins University
Investigators
Principal Investigator: Robert K Brooner, Ph.D. Johns Hopkins University
  More Information

No publications provided

Responsible Party: Robert Brooner, Professor of Psychiatry and Behavioral Sciences, Johns Hopkins University
ClinicalTrials.gov Identifier: NCT00787735     History of Changes
Other Study ID Numbers: R01-DA 016375, R01DA016375
Study First Received: November 6, 2008
Last Updated: March 8, 2013
Health Authority: United States: Federal Government

ClinicalTrials.gov processed this record on October 01, 2014