- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01356069
Efficacy of Time-limited Psychodynamic Psychotherapy and Informed Clinical Management in BPD High MHS Users (HUMSH)
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.
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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;
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Health Services Research
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / 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.
|
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.
|
This treatment consisted in a combination of medication, unstructured psychological support focused on socio-relational impairment and rehabilitative interventions provided by nurses and educators.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
MHS heavy use
Time Frame: 2 years
|
requiring more than 6 emergency interventions per year
|
2 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
psychopathological improvement
Time Frame: 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
|
2 years
|
Collaborators and Investigators
Sponsor
Investigators
- Study Chair: Secondo Fassino, MD, University of Torino
- Principal Investigator: Federico Amianto, MD, University of Torino
- Study Director: Andrea Ferrero, MD, ASL TO-04 Chivasso (TO)
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HUMHS-2004
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on General Psychopathology
-
Institut pour la Pratique et l'Innovation en PSYchologie...BPIfranceRecruiting
-
University of California, BerkeleyMind and Life Institute, Hadley, Massachusetts; The Greater Good Science Center...Active, not recruitingPsychopathologyUnited States
-
University of California, BerkeleyCompletedTransdiagnostic PsychopathologyUnited States
-
Reproductive Medicine Associates of New JerseyWithdrawnAttitudes | Psychopathology | ReactionsUnited States
-
Eunice Kennedy Shriver National Institute of Child...National Institute of Mental Health (NIMH)CompletedPsychopathologyUnited States
-
University of Notre DameRecruitingAdolescent | Parent-Child Relations | Violence | PsychopathologyUnited States
-
Tulane UniversityNational Institute of Mental Health (NIMH)Active, not recruiting
-
Boston Children's HospitalTulane University; Harvard University; University of Maryland, College Park; Inter-American... and other collaboratorsRecruitingPsychopathology | Brain Function | Socioemotional Development | Cognitive Ability | Behavioral and Neural Patterns of AttentionBrazil
-
National Institute of Mental Health (NIMH)Completed
-
Universidad de GranadaCompleted
Clinical Trials on SB-APP
-
Stony Brook UniversityCompleted
-
University of MinnesotaRecruitingCardiovascular Diseases | Type 2 DiabetesUnited States
-
GlaxoSmithKlineCompletedSchizophreniaUnited Kingdom
-
Sangamo TherapeuticsActive, not recruitingHemophilia B | Mucopolysaccharidosis I | Mucopolysaccharidosis IIUnited States
-
Medica Cor Heart HospitalUnknownCoronary Ostium Stenosis | MyonecrosisBulgaria
-
Nguyen Thi Trieu, MDCompletedCirrhosis of the LiverVietnam
-
GlaxoSmithKlineCompletedAtherosclerosisNetherlands, Belgium, Germany, Czechia, France, Austria, Spain, Norway, Poland, Denmark, Switzerland
-
GlaxoSmithKlineCompletedChronic Idiopathic Thrombocytopenic Purpura | Purpura, Thrombocytopenic, IdiopathicJapan
-
Boston Medical CenterNational Institute of Mental Health (NIMH)Completed
-
Case Comprehensive Cancer CenterActive, not recruitingAcute Myeloid Leukemia With Multilineage Dysplasia Following Myelodysplastic Syndrome | Adult Acute Megakaryoblastic Leukemia (M7) | Adult Acute Minimally Differentiated Myeloid Leukemia (M0) | Adult Acute Monoblastic Leukemia (M5a) | Adult Acute Monocytic Leukemia (M5b) | Adult Acute Myeloblastic... and other conditionsUnited States