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

Sponsor
University of Turin, Italy (Other)
Overall Status
Completed
CT.gov ID
NCT01356069
Collaborator
(none)
35
2
48

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: SB-APP
  • Other: treatment as usual
N/A

Study Design

Study Type:
Interventional
Actual Enrollment :
35 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (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.
Study Start Date :
Jan 1, 2004
Actual Primary Completion Date :
Jan 1, 2008
Actual Study Completion Date :
Jan 1, 2008

Arms and Interventions

Arm Intervention/Treatment
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.

Outcome Measures

Primary Outcome Measures

  1. MHS heavy use [2 years]

    requiring more than 6 emergency interventions per year

Secondary Outcome Measures

  1. psychopathological improvement [2 years]

    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

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No

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

Locations

No locations specified.

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

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
, ,
ClinicalTrials.gov Identifier:
NCT01356069
Other Study ID Numbers:
  • HUMHS-2004
First Posted:
May 19, 2011
Last Update Posted:
May 19, 2011
Last Verified:
May 1, 2011
Keywords provided by , ,

Study Results

No Results Posted as of May 19, 2011