Cognitive Rehabilitation Versus Psychoeducation in Psychosocial Functioning of Borderline Personality Disorder

January 9, 2014 updated by: Jose Luis Carrasco, Hospital San Carlos, Madrid

Randomized Controlled Trial Comparing the Effects on Psychosocial Functioning of Cognitive Rehabilitation Versus Psychoeducation in Borderline Personality Disorder

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).

Study Overview

Status

Completed

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

70

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Madrid, Spain, 28040
        • Hospital Clínico San Carlos

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 45 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: cognitive remediation
Cognitive remediation programme in order to improve several cognitive domains.
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.
Other Names:
  • Cognitive rehabilitation
ACTIVE_COMPARATOR: Psychoeducation
Psychoeducation group in order to improve psychosocial functioning of patients.
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.
Other Names:
  • Psychoeducation Programme

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Functioning Assessment Scale Test (FAST)
Time Frame: up to three years
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jose L Carrasco, MD, Hospital Clínico San Carlos
  • Study Chair: Juan C Pascual, MD, Hospital San Creu i San Pau
  • Study Chair: Angela Ibañez, MD, Hospital Universitario Ramón y Cajal

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

April 1, 2010

Primary Completion (ACTUAL)

June 1, 2013

Study Completion (ACTUAL)

June 1, 2013

Study Registration Dates

First Submitted

December 23, 2013

First Submitted That Met QC Criteria

January 9, 2014

First Posted (ESTIMATE)

January 10, 2014

Study Record Updates

Last Update Posted (ESTIMATE)

January 10, 2014

Last Update Submitted That Met QC Criteria

January 9, 2014

Last Verified

January 1, 2014

More Information

Terms related to this study

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.

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