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临床试验/NCT02033044
NCT02033044已完成不适用

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

Hospital San Carlos, Madrid2 个研究点 分布在 1 个国家目标入组 70 人开始时间: 2010年4月最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
70
试验地点
2
主要终点
Functioning Assessment Scale Test (FAST)

研究概览

简要总结

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).

详细描述

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.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Double (Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 45 Years(Adult)
性别
All
接受健康志愿者

入选标准

  • 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.

排除标准

  • 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.

结局指标

主要结局

Functioning Assessment Scale Test (FAST)

时间窗: 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.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Jose Luis Carrasco

Head Professor Department of Psychiatry, MD.

Hospital San Carlos, Madrid

研究点 (2)

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