Effectiveness of TCC Followed by MBCT and Predictive Factors (Genetic, Clinical and Cognitive) Response

Centre Hospitalier St Anne2 个研究点分布在 1 个国家目标入组 158 人开始时间: 2012年9月13日最近更新: 2019年11月1日

适应症

干预措施

试验速览

阶段: 不适用
状态: 终止
发起方
入组人数: 158
试验地点: 2
主要终点: Number of relapses (for bipolar disorders)

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The purpose of this study is to determine whether a Cognitive and Behavioral group Therapy (CBT) + Mindfulness Based Cognitive Therapy (MBCT) decreased relapses and hospitalizations and improved outcomes (depressive and manic symptoms, self-esteem, and quality of life) in a large sample of refractory bipolar I patients on mood stabilizers.

详细描述

In recent years, various controlled studies showed that psychoeducational interventions have been effective in decreasing relapse and improving outcomes for bipolar disorders. However, samples were often small, compromising statistical power, and with a large variety of patients. The investigators therefore tested if a CBT group psychoeducation program + MBCT decreased relapses and improved outcomes in a large sample of refractory bipolar I patients on mood stabilizers. Patients were tested at recruitment, at 6-month follow-up CBT and at 2-month follow-up MBCT using clinical interviews and self-report questionnaires. The primary outcome measure of efficacy was relapse during the follow-up requiring either hospitalization, modification of treatment or HDRS ≥ 16 or MRS ≥ 6. The secondary outcome measure was symptomatic and functional improvement.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Prevention
盲法: None

入排标准

年龄范围: 18 Years 至 65 Years（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Patients aged 18-65 years
•Men and women
•Addressed to the CBT unit of the Clinique des Maladies Mentales et de l'Encéphale - CMME- (Sainte Anne Hospital)
•Having a bipolar I or II disorder (224 patients) or eating disorder (224 patients) : bulimia or discorder of use alcohol or gambling (224 patients)
•mood stabilizer treatment for more than six months, for bipolar patients
•Understanding and speaking French fluently
•Patient agreeing to participate and signing the consent form

排除标准

•Age <18 or> 65
•current manic, hypomanic, or depressive episode for bipolar patients
•Score on the Hamilton Depression Rating Scale - HDRS greater than or equal to 16
•Score on the Mania Rating Scale - MRS higher or equal to 6 for bipolar patients
•Schizophrenic disorder
•Severe somatic pathology (cancer, heart, kidney or respiratory failure, central neurological disorder), scalable, or are likely to be life-threatening in a period of less than one year
•Refusal of a mood stabilizer treatment for bipolar patients
•Inability to respond to assessment (eg failure or deterioration of mental ability.)
•No affiliation to a social security scheme
•Private topics of liberty by judicial or administrative decision
•Pregnant women
•For bipolar patients, the presence of rapid cycling, family history of bipolar disorder, comorbid Axis I and II disorders, protective measures (curatorship or guardianship) are not exclusion criteria.