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Effectiveness of Self-Help for Dually-Diagnosed Persons - 1

Primary Purpose

Dual Diagnosis, Substance-Related Disorders, Mental Disorders

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Double Trouble in Recovery
Standard psychiatric day treatment
Sponsored by
National Institute on Drug Abuse (NIDA)
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dual Diagnosis focused on measuring 12 step groups, self help, psychiatric day treatment, co-occurring disorders, dual diagnosis

Eligibility Criteria

18 Years - 64 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria: Admission to psychiatric day treatment program 18-64 years old Exclusion Criteria: 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.

Sites / Locations

  • Albert Einstein Dept of Psychiatry

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

1

2

Arm Description

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 treatment

Outcomes

Primary Outcome Measures

drug/alcohol use

Secondary Outcome Measures

psychiatric medication adherence
traditional 12 step meeting attendance
psychiatric symptoms
program retention

Full Information

First Posted
September 20, 2005
Last Updated
January 11, 2017
Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
National Development and Research Institutes, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT00218582
Brief Title
Effectiveness of Self-Help for Dually-Diagnosed Persons - 1
Official Title
Effectiveness of Self-Help for Dually-Diagnosed Persons
Study Type
Interventional

2. Study Status

Record Verification Date
October 2008
Overall Recruitment Status
Completed
Study Start Date
March 2003 (undefined)
Primary Completion Date
March 2007 (Actual)
Study Completion Date
March 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
National Institute on Drug Abuse (NIDA)
Collaborators
National Development and Research Institutes, Inc.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dual Diagnosis, Substance-Related Disorders, Mental Disorders
Keywords
12 step groups, self help, psychiatric day treatment, co-occurring disorders, dual diagnosis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
229 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
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
Arm Title
2
Arm Type
Active Comparator
Arm Description
Standard psychiatric day treatment
Intervention Type
Behavioral
Intervention Name(s)
Double Trouble in Recovery
Intervention Description
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
Intervention Type
Behavioral
Intervention Name(s)
Standard psychiatric day treatment
Intervention Description
Individual counseling, groups, medication
Primary Outcome Measure Information:
Title
drug/alcohol use
Time Frame
past 90 days
Secondary Outcome Measure Information:
Title
psychiatric medication adherence
Time Frame
recent
Title
traditional 12 step meeting attendance
Time Frame
past 90 days
Title
psychiatric symptoms
Time Frame
recent
Title
program retention
Time Frame
up to 6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
64 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Admission to psychiatric day treatment program 18-64 years old Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Stephen Magura, Ph.D.
Organizational Affiliation
National Development and Research Institutes, Inc.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Albert Einstein Dept of Psychiatry
City
Bronx
State/Province
New York
ZIP/Postal Code
10461
Country
United States

12. IPD Sharing Statement

Citations:
PubMed Identifier
18161644
Citation
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.
Results Reference
result

Learn more about this trial

Effectiveness of Self-Help for Dually-Diagnosed Persons - 1

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