DBT Compared to I/GDC for the Treatment of Opiate Addiction in Emotionally Dysregulated Patients. - 1
Condition: Dialectical Behavior Therapy; Individual and Group Drug Counseling
MeSH terms: Behavior, Addictive
Study type: Interventional

Summary: 
      The purpose of this study is to examine the efficacy of DBT compared to a standard drug
      counseling approach for the treatment of opiate addiction and borderline personality disorder
      (BPD). Treatment research has repeatedly shown that retention of BPD and substance addicted
      individuals to be the among the most challenging for therapists. DBT has established itself
      as one of the most effective treatments for treatment retention of these patients and for
      reducing parasuicidal and self-injurious behaviors.

      This study is one of two in a multi-site RCT for the treatment of opiate addiction. DBT has
      been shown to be efficacious for the treatment of BPD patients and it has been extended in
      this study to target addictive behaviors in these patients. The study consists of three
      treatment parts: weekly individual and group therapy and suboxone maintenance medication.
      Participants are provided therapy on a weekly basis for one year and suboxone for 2 years.
      Assessments for tracking outcome are conducted every 4 months.

      It is hypothesized patients in the DBT condition will show a reduction of substance use,
      parasuicidal and other psychological difficulties and these gains will be maintained through
      the year of follow-up assessments. In addition, it is predicted that adherence to DBT
      treatment protocols will be associated with improved outcomes. Finally, it is predicted that
      treatment "dosage" (average hours of therapy/week) will be positively related to clinical
      improvement.
    

Detailed description: 
      The study design is a two arm randomized clinical trial comparing a one year treatment
      program of Dialectical Behavior Therapy (DBT) + suboxone for heroin addicted individuals
      meeting criteria for borderline personality disorder (BPD) to a one year program of standard
      drug counseling (I/GDC) + suboxone. Drug counseling will consist of manualized individual
      sessions + group therapy. Participants in both conditions will be prescribed psychotropic
      medications following a standardized medication protocol developed specifically for BPD
      individuals. Each site will enroll 86 clients with both treatment conditions being conducted
      at each site. Assessments measuring drug use, suicidal behaviors, retention and other
      treatment-related behaviors, general psychopathology and functioning, and increases in
      behavioral skills will be given at four month intervals for two years

      There are five outcome domains of principal interest in this study:

        1. Drug use: The primary outcome measure here is proportions of urinalysis (UA) coded
           positive for opiates;

        2. Suicidal behaviors: The primary outcome measure here is number of suicides + suicide
           attempts. The domain of suicidal behaviors also includes (a) the number, medical risk,
           risk/rescue score and suicide intent of all parasuicide, (b) the number of suicide
           threats and suicide crises, and (c) the level of suicidal ideation and suicide intent;

        3. Therapy-interfering behaviors: The primary outcome measure here is maintenance in
           therapy;

        4. Quality of life interfering behaviors: The primary outcome measure here is combined
           number of days on a psychiatric inpatient unit + days in jail (THI, SHI);

        5. Behavioral skills: The primary outcome measure here is the DBT Skills scale score from
           the Revised Ways of Coping Checklist (RWCCL);

        6. Risky sexual behavior: the primary outcome measure here is the number of risky sexual
           behaviors in the time period [Casual Partners questionnaire revised [CPQ-R] and diary
           card].
    

Intervention name(s): DBT; I/GDC
Intervention type(s): Behavioral; Behavioral
Intervention description(s): Dialectical behavior therapy plus opiate replacement medication.; Individual and group drug counseling plus opiate replacement medication.
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary purpose: Treatment