Clinical trial NCT01356069: Efficacy of Time-limited Psychodynamic Psychotherapy and Informed Clinical Management in BPD High MHS Users
Official title: Sequential Brief Adlerian Psychodynamic Psychotherapy in Heavy Users of a Mental Health Service With Borderline Personality Disorder: a Two Years Follow-up Preliminary Randomized Study.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Heavy MHS Use
General Psychopathology
Working Alliance
Keywords: BPD
MHS
heavy users
sequential psychotherapy
Lead sponsor: University of Turin, Italy
Sponsor class: OTHER
First posted: 2011-05-19
Enrollment: 35
Sex: ALL
Minimum age (years): 20
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: HEALTH_SERVICES_RESEARCH

Brief summary: Subjects affected with severe Borderline Personality Disorder (BPD) are often heavy users of Mental Health Services (MHS). This study evaluates the efficacy of the addition of Sequential Brief Adlerian Psychodynamic Psychotherapy (SB-APP) to the treatment-as-usual (TAU) for BPD compared to the TAU alone for a naturalistic group of heavy MHS users with BPD. The efficacy was evaluated after at 6 time points along a two years of follow-up.

Thirty-five outpatients eligible for the study were randomly assigned to two treatment groups (TAU=17; SB-APP=18). The Clinical Global Impression (CGI) and the CGI-modified (CGI-M) for BPD, the Global Assessment of Functioning (GAF), the State-Trait Anger Expression Inventory (STAXI), and the Symptom Checklist-90 Revised (SCL-90-R) were administered at T1, T3, T6, T12, T18, and T24. At T12 also the Working Alliance Inventory-Short Form (WAI-S) was filled-in by participants and compared between groups. In the one-year follow-up the SB-APP group did not receive any individual psychological support. MHS was specifically trained in BPD treatment and had regular supervisions.

Scores of the CGI, GAF, and STAXI improved after 6 and 12 months, irrespective of treatment. SB-APP group displayed a better outcome for impulsivity, suicide attempts, chronic feelings of emptiness and disturbed relationships. The results displayed a good stabilization during follow-up year even after the interruption of psychotherapy in the SB-APP group.

Even though the TAU for BPD applied to heavy MSH users displayed some efficacy in reducing symptom expression and improving global functioning, the adjunct of a specific time-limited and focused psychotherapeutic treatment reached a better outcome. In particular the possibility of a focus on patients' personality functioning (SB-APP) with a specific psychotherapeutic approach seemed to be more effective than the general support to social impairment offered by the TAU approach.


Eligibility criteria: Inclusion criteria: (a) diagnosis of BPD according to DSM-IV-TR criteria; (b) age between 20 and 50 years; (c) heavy use of MHS during the year before the study - as defined below; and (h) signed informed consent.

Exclusion Criteria: (d) acute full-syndrome Axis I disorder requiring urgent inpatient treatment; (e) current Substance Dependence Disorder; (f) moderate to severe Mental Retardation; (g) previous treatment with structured psychotherapy;

Primary outcomes:
measure: MHS heavy use
timeFrame: 2 years
Secondary outcomes:
measure: psychopathological improvement
timeFrame: 2 years
Other outcomes:
Locations:
Study officials:
affiliation: University of Torino
name: Federico Amianto, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: ASL TO-04 Chivasso (TO)
name: Andrea Ferrero, MD
role: STUDY_DIRECTOR
affiliation: University of Torino
name: Secondo Fassino, MD
role: STUDY_CHAIR
References:
citation: Storebo OJ, Stoffers-Winterling JM, Vollm BA, Kongerslev MT, Mattivi JT, Jorgensen MS, Faltinsen E, Todorovac A, Sales CP, Callesen HE, Lieb K, Simonsen E. Psychological therapies for people with borderline personality disorder. Cochrane Database Syst Rev. 2020 May 4;5(5):CD012955. doi: 10.1002/14651858.CD012955.pub2.
citation: Amianto F, Ferrero A, Piero A, Cairo E, Rocca G, Simonelli B, Fassina S, Abbate-Daga G, Fassino S. Supervised team management, with or without structured psychotherapy, in heavy users of a mental health service with borderline personality disorder: a two-year follow-up preliminary randomized study. BMC Psychiatry. 2011 Nov 21;11:181. doi: 10.1186/1471-244X-11-181.