Cognitive Rehabilitation Versus Psychoeducation in Psychosocial Functioning of Borderline Personality Disorder
Primary Purpose
Neuropsychology
Status
Completed
Phase
Not Applicable
Locations
Spain
Study Type
Interventional
Intervention
cognitive remediation
Psychoeducation
Sponsored by
About this trial
This is an interventional treatment trial for Neuropsychology focused on measuring borderline personality disorder, cognitive rehabilitation, psychoeducation, psychosocial functioning
Eligibility Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Sites / Locations
- Hospital Clinico San Carlos
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
cognitive remediation
Psychoeducation
Arm Description
Cognitive remediation programme in order to improve several cognitive domains.
Psychoeducation group in order to improve psychosocial functioning of patients.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02033044
First Posted
December 23, 2013
Last Updated
January 9, 2014
Sponsor
Hospital San Carlos, Madrid
1. Study Identification
Unique Protocol Identification Number
NCT02033044
Brief Title
Cognitive Rehabilitation Versus Psychoeducation in Psychosocial Functioning of Borderline Personality Disorder
Official Title
Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder
Study Type
Interventional
2. Study Status
Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
June 2013 (Actual)
Study Completion Date
June 2013 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Hospital San Carlos, Madrid
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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).
Detailed Description
To ensure the reliability among centers regarding the evaluation and the treatment fidelity, two meetings were organized before the start of the study to train therapists in the evaluations and interventions.
Clinical and neuropsychological evaluations before interventions were administered in different days since they lasted in general more than one hour each one and the effect of fatigue or boredom might affect the results. Clinical interviews were performed by experienced psychiatrists and psychologists during 3 months to ensure the follow-up of all participants prospectively. The following sociodemographic and clinical variables were collected: age at recruitment, gender, education level, occupational status, and pharmacological treatment. All participants were then randomized to receive CR or PE in a 1:1 ratio stratified by center, age, and education level. Randomization was accomplished with the use of computer-generated sequence.
During the study, subjects did not receive any other individual or group psychotherapy. All patients continued pharmacological treatment if it had been initiated prior to inclusion. Type and doses of medication could not be modified during the study period. Both interventions were applied in a group format and were conducted by two psychologists with experience in managing patients with BPD. Subjects were instructed not to disclose any information about the intervention to maintain blind conditions. Participants were evaluated at baseline, after completion of the intervention, and six months after the end of the interventions.
The study was conducted in accordance with the ethical principles of the Declaration of Helsinki and the approval of the Ethical Committee for this study was obtained. All subjects received extensive information about the study and provided written informed consent before they were enrolled in the study.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neuropsychology
Keywords
borderline personality disorder, cognitive rehabilitation, psychoeducation, psychosocial functioning
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
70 (Actual)
8. Arms, Groups, and Interventions
Arm Title
cognitive remediation
Arm Type
Experimental
Arm Description
Cognitive remediation programme in order to improve several cognitive domains.
Arm Title
Psychoeducation
Arm Type
Active Comparator
Arm Description
Psychoeducation group in order to improve psychosocial functioning of patients.
Intervention Type
Other
Intervention Name(s)
cognitive remediation
Other Intervention Name(s)
Cognitive rehabilitation
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
Psychoeducation
Other Intervention Name(s)
Psychoeducation Programme
Intervention Description
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.
Primary Outcome Measure Information:
Title
Functioning Assessment Scale Test (FAST)
Description
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.
Time Frame
up to three years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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.
Exclusion Criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jose L Carrasco, MD
Organizational Affiliation
Hospital Clinico San Carlos
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Juan C Pascual, MD
Organizational Affiliation
Hospital San Creu i San Pau
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Angela Ibañez, MD
Organizational Affiliation
Hospital Universitario Ramon y Cajal
Official's Role
Study Chair
Facility Information:
Facility Name
Hospital Clinico San Carlos
City
Madrid
ZIP/Postal Code
28040
Country
Spain
12. IPD Sharing Statement
Citations:
PubMed Identifier
23511717
Citation
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.
Results Reference
background
PubMed Identifier
32368793
Citation
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.
Results Reference
derived
PubMed Identifier
26487284
Citation
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.
Results Reference
derived
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Cognitive Rehabilitation Versus Psychoeducation in Psychosocial Functioning of Borderline Personality Disorder
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