Comparative Efficacy of Two Adjunctive Psychosocial Interventions (Mindfulness or Psychoeducation) Versus Treatment as Usual in Bipolar Patients With Subsyndromal Deppresive Symptoms: A Pilot Randomized Trial
试验速览
- 阶段
- 不适用
- 入组人数
- 140
- 试验地点
- 4
- 主要终点
- Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
研究概览
简要总结
This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment.
详细描述
This is a parallel 3-group, multicenter, prospective, randomized, single-blind (evaluator) controlled pilot trial, with a 38- week follow-up. Patients diagnosed with bipolar disorder (BD) according to DSM -5 criteria for mild depression or subsyndromal depressive symptoms are assigned to one of the following 3 treatment groups: 1) psychopharmacological treatment plus Mindfulness Based Cognitive Therapy (MBCT); 2) psychopharmacological treatment plus structured group psychoeducation; 3) treatment as usual (TAU), including standard psychiatric care with standard pharmacologic treatment. After written informed consent is signed, patients meeting the inclusion criteria are randomized (2:2:1 ratio) through a Random Allocation Software. All three groups are assessed at baseline (t0), immediately after completing the program (t1; 8 weeks) and at follow-up six months after randomization. The assessments include the following variables: depression, anxiety, general and social cognition, global functioning, BDNF, and other clinical variables. The evaluator who collected the biomarkers and the clinical and psychometric data will be blind to treatment. The interrater variability between all researchers will be checked.
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
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-60 years
- •BD type I or II, in clinical remission of acute mood episode at least in the three months prior to study
- •Having presented an acute affective episode in the past 3 years
- •Having presented at least two depressive episodes throughout his life.
- •Monotherapy or combination with a mood stabilizer (lithium, valproate, carbamazepine or lamotrigine) at optimal doses (ie, in serum levels within the therapeutic range: 0.6-1.2 mEq / L for lithium, 50-100 ug / ml for valproate, and 5-12 mcg / mL for carbamazepine), or quetiapine monotherapy or in combination with the aforementioned stabilizers, or any oral atypical antipsychotic in combination with an antidepressant
- •Hamilton Depression Rating Scale [HDRS]-17 score ≥ 8 and ≤ 19 and Young Mania Rating Scale [YMRS] score <8
- •Being able to understand and comply with the requirements of the trial
- •Written consent to participate in the study.
排除标准
- •Any acute mood episode in the 12 weeks before the start of the trial.
- •Any current DSM -5 diagnosis different from bipolar disorder (including substance or alcohol use disorder at the time of study entry, except if it is under complete remission. Not applicable to nicotine or caffeine)
- •Risk of suicide or self/hetero aggressiveness
- •Pregnancy
- •Severe and unstable medical pathology.
- •Patients who are currently receiving structured psychotherapy or structured group psychoeducation about bipolar disorder, or who have received structured psychoeducation in the past 5 years
- •Patients who are treated with a different mood stabilizer to lithium , valproate , carbamazepine , lamotrigine, a classic antipsychotic or antidepressant monotherapy at the time of the randomization
- •Treatment with a depot antipsychotic
- •Participation in another clinical trial within 4 weeks prior to randomization
- •Mental Retardation
结局指标
主要结局
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS)
时间窗: from baseline (V0) to week 8 (V1)
Primary endpoint of the study is given by changes in the overall score of the Hamilton Rating Scale for Depression (HDRS), from baseline (V0) to week 8 (v1) for each of the treatment groups.
次要结局
- Changes in scale score of Clinical Global Impression CGI-BP(from baseline (V0) to week 8 (V1))
- Changes in the score of the Hamilton Rating Scale for Anxiety HAM-A(from baseline (V0) to week 8 (V1))
- Cognitive changes(from baseline (V0) to week 8 (V1))
- Functioning(from baseline (V0) to week 8 (V1))
- Changes in the global score of Young Mania Rating Scale (YMRS)(from baseline (V0) to week 8 (V1))
- Plasmatic levels of Brain-Derived Neurotrophic Factor (BDNF):(from baseline (V0) to week 8 (V1))
- Recurrence(from baseline (V0) to week 8 (V1))