Text Size

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

This study has been completed.
Sponsor:
Collaborator:
National Development and Research Institutes, Inc.
Information provided by:
National Institute on Drug Abuse (NIDA)
ClinicalTrials.gov Identifier:
NCT00218582
First received: September 20, 2005
Last updated: October 27, 2008
Last verified: October 2008
History of Changes
  Purpose

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.


Condition Intervention Phase
Dual Diagnosis
Substance-Related Disorders
Mental Disorders
 Behavioral: Double Trouble in Recovery
Behavioral: Standard psychiatric day treatment
 Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Effectiveness of Self-Help for Dually-Diagnosed Persons

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by National Institute on Drug Abuse (NIDA):

Primary Outcome Measures:
  • drug/alcohol use [ Time Frame: past 90 days ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • psychiatric medication adherence [ Time Frame: recent ] [ Designated as safety issue: No ]
  • traditional 12 step meeting attendance [ Time Frame: past 90 days ] [ Designated as safety issue: No ]
  • psychiatric symptoms [ Time Frame: recent ] [ Designated as safety issue: No ]
  • program retention [ Time Frame: up to 6 months ] [ Designated as safety issue: No ]

Enrollment: 229
Study Start Date: March 2003
Study Completion Date: March 2007
Primary Completion Date: March 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
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
 Behavioral: Double Trouble in Recovery
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
Active Comparator: 2
Standard psychiatric day treatment
 Behavioral: Standard psychiatric day treatment
Individual counseling, groups, medication

  Eligibility

Ages Eligible for Study:   18 Years to 64 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00218582

Locations
United States, New York
Albert Einstein Dept of Psychiatry
Bronx, New York, United States, 10461
Sponsors and Collaborators
National Institute on Drug Abuse (NIDA)
National Development and Research Institutes, Inc.
Investigators
Principal Investigator: Stephen Magura, Ph.D. National Development and Research Institutes, Inc.
  More Information

Publications:

Responsible Party: Stephen Magura, Western Michigan University
ClinicalTrials.gov Identifier: NCT00218582     History of Changes
Other Study ID Numbers: NIDA-15912-1, R01-15912-1
Study First Received: September 20, 2005
Last Updated: October 27, 2008
Health Authority: United States: Federal Government

Keywords provided by National Institute on Drug Abuse (NIDA):
12 step groups
self help
psychiatric day treatment
co-occurring disorders
dual diagnosis

Additional relevant MeSH terms:
Mental Disorders
Psychotic Disorders
Substance-Related Disorders
Schizophrenia and Disorders with Psychotic Features

ClinicalTrials.gov processed this record on June 18, 2013