Cognitive Rehabilitation Versus Psychoeducation in Psychosocial Functioning of Borderline Personality Disorder

Not Applicable

Completed

• Conditions: Neuropsychology
• Interventions: Other: cognitive remediation; Other: Psychoeducation

• Registration Number: NCT02033044
• Lead Sponsor: Hospital San Carlos, Madrid

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.

Study Timeline

• Study Start: 2010-04
• Primary Completion: 2013-06
• Study Completion: 2013-06
• Study First Submitted: 2013-12-23
• Status Verified: 2014-01
• Study First Submitted QC: 2014-01-09
• Last Update Submitted: 2014-01-09
• Study First Posted: 2014-01-10
• Last Update Posted: 2014-01-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 70

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
cognitive remediation	cognitive remediation	Cognitive remediation programme in order to improve several cognitive domains.
Psychoeducation	Psychoeducation	Psychoeducation group in order to improve psychosocial functioning of patients.

Primary Outcome Measures

Name	Time	Method
Functioning Assessment Scale Test (FAST)	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.

Trial Locations

Locations (1)

Hospital Clinico San Carlos; 🇪🇸 Madrid, Spain