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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT00086398
Other study ID # NIDA-14967-1
Secondary ID R01-14967-1
Status Recruiting
Phase Phase 2
First received July 1, 2004
Last updated November 3, 2005
Start date September 2001

Study information

Verified date November 2005
Source National Institute on Drug Abuse (NIDA)
Contact Samuel Ball, Ph.D.
Phone (203)937-3486
Email samuel.ball@yale.edu
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of Therapeutic Community (TC) residents.


Description:

Therapeutic Community (TC) treatment can be effective psychosocial modality for addiction, but premature dropout remains a major problem. Personality disorders are very common in residential programs, and TCs regard personality disturbance as core to all people with addiction. Severe personality dysfunction is associated with higher dropout rates from TCs, and adding cognitive-behavioral treatments may improve retention and outcome. We hypothesize that severe personality disturbance causes significant problems with an individual?s initial adjustment and effective utilization of TC processes and techniques. We predict that a behavioral therapy that targets personality pathology will result in better early retention and engagement than will a more standard addiction counseling approach.

To begin to improve retention, TC research must begin to systematically evaluate the impact of adding interventions targeted at decreasing premature dropouts through controlled clinical trials. We have developed the first empirically tested treatment manual for the full range of personality disorders in substance abusers and propose to conduct a randomized clinical trial to evaluate the efficacy of Dual Focus Schema Therapy in comparison to Individual Drug Counseling as 6-month manualized individual behavioral therapy enhancements to the orientation/early treatment process of 100 TC residents. In addition to evaluating retention differences, we will analyze the rate and degree of change for these two conditions monthly and at 6, 12, 18, and 24-month follow-up for psychological indicators related to personality disorder and therapeutic processes related to the TC.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group 15 Years to 65 Years
Eligibility Admission for residential TC treatment at APT Residential Services Division

Inclusion Criteria:

Adolescent or adult substance abuser; provide 2 or more contacts; ability to read and speak English

Exclusion Criteria:

Acute suicidality, homicidality, psychosis, mania

Study Design

Intervention Model: Factorial Assignment, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Behavior Therapy


Locations

Country Name City State
United States APT Residential Services Division New Haven Connecticut

Sponsors (1)

Lead Sponsor Collaborator
National Institute on Drug Abuse (NIDA)

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Retention
Primary Psychosocial functioning
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