Clinical trial NCT03123198: Dialectical Behavior Therapy Rutgers University Research Program
Official title: Dialectical Behavior Therapy Rutgers University Research Program
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Borderline Personality Disorder
Keywords: borderline personality disorder
suicidal behaviors
dialectical behavior therapy
Lead sponsor: Rutgers, The State University of New Jersey
Sponsor class: OTHER
First posted: 2017-04-21
Enrollment: 145
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This protocol establishes a research oriented psychological treatment clinic within the Graduate School of Applied and Professional Psychology (GSAPP), called the Dialectical Behavior Therapy Rutgers University Research Program (DBT-RU). The overall aim of the proposed research is to find ways to improve therapist training in existing treatments for complex and difficult-to-treat problems (e.g., DBT, prolonged exposure), develop new and more effective treatments, and improve understanding of severe psychopathology. Consequently, this proposed research will have four branches: (1) training of research clinicians and evaluation of training methods; (2) training of clinical evaluators for the research studies and evaluation of assessment training methods; (3) assessment of treatment outcome, including assessment of mediators and moderators of change (both clinician and client data); (4) assessment and analyses of psychopathology of subject populations who participate in the DBT-RU.

Detailed description: DBT is an evidence-based and empirically supported treatment for borderline personality disorder (BPD), suicide, and self-injury. DBT is traditionally administered for a minimum of 6 months in an outpatient setting but has been adapted to be used in other treatment settings (e.g., intensive outpatient). DBT consists of multiple key components, including weekly individual therapy, group skills training, and option to engage in out-of-session contact with their provider via telephone to receive coaching on how to use DBT skills to manage real-life issues (e.g., urges to harm self). To date, more than a dozen randomized control trials (RCTs) and quasi-experimental studies have been conducted, and compared to 12 months of treatment as usual (TAU), DBT has been shown to result in significantly greater reduction in frequency and severity of self-injurious behaviors, inpatient hospitalizations, suicidal ideation, and substance abuse (see Panos, Jackson, Hasan, \& Panos, 2014 ). This research aims to (1) advance our understanding of underlying mechanisms driving treatment outcomes; (2) isolate the effects of particular components and strategies employed in DBT on various outcomes (e.g., suicide), (3) enhance training and evaluation methods for research clinicians; (4) test to see if benefits in DBT are sustained over a period of time beyond follow-up; and (5) advance our knowledge of how DBT operates in everyday life to reduce day-to-day emotion dysregulation and related target behaviors (e.g., suicidal behavior).

Eligibility criteria: Inclusion Criteria:

A. Age 18 years or older. B. Agreement to take part in assessments, videotaping/audiotaping and coding of their sessions by research personnel.

C. Agreement to pay for mental health services at the DBT-RU, and to participate in research assessments as volunteers.

D. Residence within commuting distance of clinic (\< 45 minutes) E. Agreement to discontinue other forms of therapy F. Meets criteria for borderline personality disorder (BPD)

Exclusion Criteria:

* A. Clients who need mental health services not available at the DBT-RU, such as treatment for schizophrenia or life-threatening anorexia, or who are currently obtaining optimum professional treatment that should not be ended.

B. Non-English speaking. C. Present DSM-IV diagnosis of Mental Retardation. D. Unable to understand research consent forms.

Primary outcomes:
measure: Self-Injurious Thoughts and Behaviors Interview
timeFrame: Past six months
measure: Structured Clinical Interview for DSM-5
timeFrame: At baseline, lifetime history is assessed. At 3-months and 6-months, changes to diagnostic status are assessed.
Secondary outcomes:
measure: Difficulties in Emotion Regulation Scale
timeFrame: Past two weeks
measure: Borderline Symptom List (BSL-23)
timeFrame: Past 1 month
measure: Brief Symptom Inventory (BSI)
timeFrame: Past 1 week
Other outcomes:
Locations:
city: Piscataway
country: United States
facility: Rutgers University
state: New Jersey
Study officials:
References:
citation: Fitzpatrick S, Bailey K, Rizvi SL. Changes in Emotions Over the Course of Dialectical Behavior Therapy and the Moderating Role of Depression, Anxiety, and Posttraumatic Stress Disorder. Behav Ther. 2020 Nov;51(6):946-957. doi: 10.1016/j.beth.2019.12.009. Epub 2019 Dec 30.