NCT01356069

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
35

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2004

Longer than P75 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2004

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2008

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2008

Completed
3.4 years until next milestone

First Submitted

Initial submission to the registry

May 16, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

May 19, 2011

Completed
Last Updated

May 19, 2011

Status Verified

May 1, 2011

Enrollment Period

4 years

First QC Date

May 16, 2011

Last Update Submit

May 18, 2011

Conditions

Keywords

BPDMHSheavy userssequential psychotherapy

Outcome Measures

Primary Outcomes (1)

  • MHS heavy use

    requiring more than 6 emergency interventions per year

    2 years

Secondary Outcomes (1)

  • psychopathological improvement

    2 years

Study Arms (2)

SB-APP Psychotherapy

EXPERIMENTAL

Patients, who signed the informed consent, were randomly assigned to SB-APP in addition to TAU (n=18) or to TAU alone (n=17) groups. The SB-APP group received the usual treatment plus SB-APP (40 weekly sessions) for 10 or 11 months. At the term of the first year (T12) the TAU group continued with the TAU management with supportive weekly session whilst the SB-APP group was carried on with the psychiatric, nurse, educational management without any individual psychological support. The number of sessions performed by the two groups in the first year (T0-T12) was programmed to be almost the same to reduce the number of sessions bias comparing the specific quality of treatments.

Other: SB-APP

TAU treatment

ACTIVE COMPARATOR

This treatment consisted in a combination of medication, unstructured psychological support focused on socio-relational impairment and rehabilitative interventions provided by nurses and educators. The medication was administered according to the APA guidelines \[18\] for good clinical practice with regard to BPD.

Other: treatment as usual

Interventions

SB-APPOTHER

SB-APP, derived from Brief-Adlerian Psychodynamic Psychotherapy (B-APP) is a time-limited (40 weekly sessions) psychodynamic psychotherapy based on Alfred Adler's theory and delivered in sequential and repeatable modules. SB-APP is focused specifically on four personality functioning levels (PFL). These are assessed by the therapists on the basis of symptoms, quality of interpersonal relationships, overall social behaviors, cognitive and emotional patterns, and defense mechanisms

SB-APP Psychotherapy

This treatment consisted in a combination of medication, unstructured psychological support focused on socio-relational impairment and rehabilitative interventions provided by nurses and educators.

TAU treatment

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (2)

  • 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.

  • 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.

MeSH Terms

Interventions

Therapeutics

Study Officials

  • Federico Amianto, MD

    University of Torino

    PRINCIPAL INVESTIGATOR
  • Andrea Ferrero, MD

    ASL TO-04 Chivasso (TO)

    STUDY DIRECTOR
  • Secondo Fassino, MD

    University of Torino

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 16, 2011

First Posted

May 19, 2011

Study Start

January 1, 2004

Primary Completion

January 1, 2008

Study Completion

January 1, 2008

Last Updated

May 19, 2011

Record last verified: 2011-05