NCT02033044

Brief Summary

Study design was a multicenter, randomized, rater-blind clinical trial. There were two-parallel arms (1:1) to evaluate functional, clinical and cognitive efficacy of a specific cognitive rehabilitation group intervention (CR) compared with a psychoeducational group intervention (PE) in subjects with Borderline Personality Disorder (BPD).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
70

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2010

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2010

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2013

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

December 23, 2013

Completed
18 days until next milestone

First Posted

Study publicly available on registry

January 10, 2014

Completed
Last Updated

January 10, 2014

Status Verified

January 1, 2014

Enrollment Period

3.2 years

First QC Date

December 23, 2013

Last Update Submit

January 9, 2014

Conditions

Neuropsychology

Keywords

borderline personality disordercognitive rehabilitationpsychoeducationpsychosocial functioning

Outcome Measures

Primary Outcomes (1)

  • Functioning Assessment Scale Test (FAST)

    This test is a 24-item scale that measures the level of psychosocial functioning of patients in daily life situations. It assesses six functional domains: autonomy, occupational functioning, cognitive functioning, financial issues, interpersonal relationships, and leisure time. Higher scores indicate higher functional impairment. This instrument has shown good psychometric properties and sensitivity to change.

    up to three years

Study Arms (2)

cognitive remediation

EXPERIMENTAL

Cognitive remediation programme in order to improve several cognitive domains.

Other: cognitive remediation

Psychoeducation

ACTIVE COMPARATOR

Psychoeducation group in order to improve psychosocial functioning of patients.

Other: Psychoeducation

Interventions

cognitive remediationOTHER

Cognitive Rehabilitation (CR). Consisted on group sessions (5 individuals per group) of 120-minutes, twice a week during a total period of 16 weeks (32 sessions). The exercises addressed neurocognitive issues related to sustained attention, processing speed, memory and executive functioning. The whole program aimed at getting new strategies to improve functional adaptation, thus tasks were carried out in the clinical setting and at home. Some homework tasks were based on their daily life difficulties and problems. The main objective of this program was the generalization of rehabilitated cognitive functions to daily life activities. Most of the techniques were based on a previous program for bipolar disorder.

Also known as: Cognitive rehabilitation
cognitive remediation
PsychoeducationOTHER

Psychoeducation (PE). The psychoeducation intervention consisted of 16 weekly group sessions of 5 individuals of 120 minutes each (16 sessions). This therapy aimed at improving illness' consciousness , interpersonal abilities, family balance, therapeutical adherence, emotional management in frustrating situations, problems resolutions, and lifestyle regularity. On this intervention, no homework tasks were required. This intervention was based on the Systems Training for Emotional Predictability and Problem Solving (STEPPS) program therapy.

Also known as: Psychoeducation Programme
Psychoeducation

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Outpatients aged 18 to 45 years;
  • Diagnoses of BPD according to Diagnostic and Statistical Manual for Mental Disorders (4th version Revised) (DSM-IV-TR) criteria and evaluated by two semi-structured diagnostic interviews
  • Structured Clinical Interview for DSM-IV Axis II Disorders (SCID-II) and the Revised Diagnostic Interview for Borderlines (DIB-R)
  • Clinical severity measured with Clinical Global Impression for BPD (CGI-BPD) higher than 4;
  • Functional impairment measured with a Global Assessment Functioning (GAF) lower than 65.

You may not qualify if:

  • No severe physical conditions, such as organic brain syndrome or neurological disease that could affect neuropsychological performance;
  • Intelligence Quotient (IQ) \< 85;
  • Major Depression Disorder (MDD) or substance misuse within the last 6 months;
  • Schizophrenia, severe psychotic disorder or bipolar disorder;
  • Previous participation in any psychoeducation or cognitive rehabilitation intervention.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Clinico San Carlos

Madrid, Madrid, 28040, Spain

Location

Related Publications (3)

  • Torrent C, Bonnin Cdel M, Martinez-Aran A, Valle J, Amann BL, Gonzalez-Pinto A, Crespo JM, Ibanez A, Garcia-Portilla MP, Tabares-Seisdedos R, Arango C, Colom F, Sole B, Pacchiarotti I, Rosa AR, Ayuso-Mateos JL, Anaya C, Fernandez P, Landin-Romero R, Alonso-Lana S, Ortiz-Gil J, Segura B, Barbeito S, Vega P, Fernandez M, Ugarte A, Subira M, Cerrillo E, Custal N, Menchon JM, Saiz-Ruiz J, Rodao JM, Isella S, Alegria A, Al-Halabi S, Bobes J, Galvan G, Saiz PA, Balanza-Martinez V, Selva G, Fuentes-Dura I, Correa P, Mayoral M, Chiclana G, Merchan-Naranjo J, Rapado-Castro M, Salamero M, Vieta E. Efficacy of functional remediation in bipolar disorder: a multicenter randomized controlled study. Am J Psychiatry. 2013 Aug;170(8):852-9. doi: 10.1176/appi.ajp.2012.12070971.

    PMID: 23511717BACKGROUND

  • 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.

    PMID: 32368793DERIVED

  • Pascual JC, Palomares N, Ibanez A, Portella MJ, Arza R, Reyes R, Feliu-Soler A, Diaz-Marsa M, Saiz-Ruiz J, Soler J, Carrasco JL. Efficacy of cognitive rehabilitation on psychosocial functioning in Borderline Personality Disorder: a randomized controlled trial. BMC Psychiatry. 2015 Oct 21;15:255. doi: 10.1186/s12888-015-0640-5.

    PMID: 26487284DERIVED

MeSH Terms

Conditions

Borderline Personality Disorder

Interventions

Cognitive RemediationCognitive Training

Condition Hierarchy (Ancestors)

Personality DisordersMental Disorders

Intervention Hierarchy (Ancestors)

Behavior TherapyPsychotherapyBehavioral Disciplines and ActivitiesNeurological RehabilitationRehabilitationAftercareContinuity of Patient CarePatient CareTherapeuticsHealth ServicesHealth Care Facilities Workforce and Services

Study Officials

  • Jose L Carrasco, MD

    Hospital Clinico San Carlos

    PRINCIPAL INVESTIGATOR

  • Juan C Pascual, MD

    Hospital San Creu i San Pau

    STUDY CHAIR

  • Angela Ibañez, MD

    Hospital Universitario Ramon y Cajal

    STUDY CHAIR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Head Professor Department of Psychiatry, MD.

Study Record Dates

First Submitted

December 23, 2013

First Posted

January 10, 2014

Study Start

April 1, 2010

Primary Completion

June 1, 2013

Study Completion

June 1, 2013

Last Updated

January 10, 2014

Record last verified: 2014-01

Locations

ES(1)