Assessment of Cost-effectiveness in Two Empirically-based Psychotherapies for Borderline Personality Disorder: A Randomized Controlled Trial

Not Applicable

Not yet recruiting

• Conditions: Treatment 1:Dialectical Behavior Therapy (DBT); Treatment 2:Dynamic Deconstructive Psychotherapy (DDP); Placebo
• Interventions: Behavioral: DBT; Behavioral: DDP; Other: control group

• Registration Number: NCT04309045
• Lead Sponsor: Shalvata Mental Health Center

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.

Study Timeline

• Status Verified: 2020-03
• Study First Submitted: 2020-03-12
• Study First Submitted QC: 2020-03-12
• Last Update Submitted: 2020-03-12
• Study First Posted: 2020-03-16
• Last Update Posted: 2020-03-16
• Study Start: 2020-04-01
• Primary Completion: 2024-10-22
• Study Completion: 2024-10-22

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 60

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
DBT	DBT	Standard DBT treatment
DDP	DDP	dynamic deconstructive psychotherapy (DDP) treatment, is part of a trend of dynamic therapies to treat borderline personality disorder. DDP is a treatment specifically developed for a population with more severe symptoms those dealing with borderline personality disorder.
control group	control group	patients on the waiting list for treatment, or patients in the hospital under routine care. Which will form the control group.

Primary Outcome Measures

Name	Time	Method
Incremental cost-effectiveness ratio (ICER)	The expected duration of treatment is about one year	The measure will be assessed by comparing health care use costs in ratio to improvement on the Columbia hardware rating scale.