Efficacy of Time-limited Psychodynamic Psychotherapy and Informed Clinical Management in BPD High MHS Users (HUMSH)

This study has been completed.
Sponsor:
Information provided by:
University of Turin, Italy
ClinicalTrials.gov Identifier:
NCT01356069
First received: May 16, 2011
Last updated: May 18, 2011
Last verified: May 2011
  Purpose

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.


Condition Intervention
Heavy MHS Use
General Psychopathology
Working Alliance
Other: SB-APP
Other: treatment as usual

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Health Services Research
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.

Resource links provided by NLM:


Further study details as provided by University of Turin, Italy:

Primary Outcome Measures:
  • MHS heavy use [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    requiring more than 6 emergency interventions per year


Secondary Outcome Measures:
  • psychopathological improvement [ Time Frame: 2 years ] [ Designated as safety issue: No ]
    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


Enrollment: 35
Study Start Date: January 2004
Study Completion Date: January 2008
Primary Completion Date: January 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: SB-APP Psychotherapy
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

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

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

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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;

  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01356069

Sponsors and Collaborators
University of Turin, Italy
Investigators
Principal Investigator: Federico Amianto, MD University of Torino
Study Director: Andrea Ferrero, MD ASL TO-04 Chivasso (TO)
Study Chair: Secondo Fassino, MD University of Torino
  More Information

No publications provided

Responsible Party: Prof. Secondo Fassino, University of Torino, Neurosciences Depatment
ClinicalTrials.gov Identifier: NCT01356069     History of Changes
Other Study ID Numbers: HUMHS-2004
Study First Received: May 16, 2011
Last Updated: May 18, 2011
Health Authority: Italy: Ministry of Health

Keywords provided by University of Turin, Italy:
BPD
MHS
heavy users
sequential psychotherapy

Additional relevant MeSH terms:
Borderline Personality Disorder
Mental Disorders
Personality Disorders

ClinicalTrials.gov processed this record on October 20, 2014