Clinical trial NCT04309045: Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial
Official title: Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Treatment 1:Dialectical Behavior Therapy (DBT)
Treatment 2:Dynamic Deconstructive Psychotherapy (DDP)
Placebo
Lead sponsor: Shalvata Mental Health Center
Sponsor class: OTHER
First posted: 2020-03-16
Enrollment: 60
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: Patients suffering from borderline personality disorder (BPD) are considered frequent utilizers of psychiatric emergency rooms and of psychiatric hospitalizations. Nonetheless, recent studies challenge the effectiveness of psychiatric hospitalizations in reducing BPD symptoms, and some have even indicated potentially harmful effects such as increasing suicide risk post-discharge. These findings highlight the importance of effective outpatient treatments for BPD patients in public psychiatric hospital settings. In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP).

Detailed description: In this study we aim to assess the effectiveness and cost-effectiveness of two empirically-based treatments for BPD: dialectical behavior therapy (DBT) and dynamic deconstructive psychotherapy (DDP). Sixty-eight participants with BPD will be randomized to each of two treatment groups. Participants and therapists will be recruited from the Shalvata MHC, a 139-bed psychiatric institution with outpatient units serving a population of more than 600,000 people in Israel. A blinded research assistant will administer primary and secondary outcome measures every 3 months during the 12 months of treatment and at the end of the 6-month naturalistic follow-up period after ending treatment with DDP or DBT. Therapist adherence will be systematically assessed in both treatments for 10% of sessions. Primary outcome measure will be comprised of the Incremental cost-effectiveness ratio (ICER), as assessed by estimating the healthcare utilization costs per incremental improvement in suicide severity. Secondary outcome measures will include BPD and depression symptom severity and quality of life. This study was submitted to the institutional review board of the Shalvata MHC in November 2019, and is expected to be approved by late Janury 2020.

Eligibility criteria: Inclusion Criteria:

* between 18 and 45 years old
* diagnosis of BPD,
* history of a suicide attempt within the prior year with presence of current suicidal ideation,
* agrees to participate in psychotherapy
* signed informed consent,

Exclusion Criteria:

* meet diagnostic criteria for schizophrenia, schizoaffective disorders, or have severe intellectual impairment.

Primary outcomes:
measure: Incremental cost-effectiveness ratio (ICER)
timeFrame: The expected duration of treatment is about one year
Secondary outcomes:
Other outcomes:
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