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

Not Applicable

Completed

• Conditions: Study Focusing on Integrated Versus Non-integrated Psychiatric Care in; Diagnoses; Opioid-dependent and Methadone Treated Patients With Other Psychiatric
• Interventions: Behavioral: Counseling compliance

• Registration Number: NCT00787735
• Lead Sponsor: Johns Hopkins University

Brief 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 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 Timeline

• Study Start: 2004-01
• Study First Submitted: 2008-11-06
• Study First Submitted QC: 2008-11-06
• Study First Posted: 2008-11-07
• Primary Completion: 2009-06
• Study Completion: 2009-06
• Status Verified: 2017-03
• Last Update Submitted: 2017-03-02
• Last Update Posted: 2017-03-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 380

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.

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Integrated Care	Counseling compliance	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.
Parallel Care	Counseling compliance	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.

Primary Outcome Measures

Name	Time	Method
Days to first psychiatric appointment	within first 90 days of randomized care
Overall psychiatric counseling attendance compliance rate	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	90, 180, and up to 365 days
Individual and group psychiatric session attendance compliance rate	90, 180, and up to 365 days

Secondary Outcome Measures

Name	Time	Method
Urinalysis results	90, 180, and up to 365 days	Urinalysis tests are collected weekly. Results include tests for opioids, cocaine, benzodiazepines, and cannabis.
Level of psychiatric distress	90, 180, and up to 365 days	Measured monthly using the Symptom Checklist 90-Revised (SCL90)

Trial Locations

Locations (1)

Addiction Treatment Services; 🇺🇸 Baltimore, Maryland, United States