Dialectical Behavior Therapy Clinical Trial
Official title:
Evaluation of Dialectical Behavior Therapy in Treatment of Opioid Addiction and Emotional Problems
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.
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].
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Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05741268 -
Effect of Dialectical Behavior in Patients With Bipolar Disorder
|
N/A |