Italian Network for the Improvement of Compliance in Depression
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 1,264
- 试验地点
- 2
- 主要终点
- Proportion of patients showing good compliance, as measured at six months from the beginning of the treatment.
研究概览
简要总结
The RIMAT-De study (Rete Italiana per il Miglioramento dell'Adesione al Trattamento nella Depressione) is a multicentric Randomized Controlled Clinical Trial aiming at identifying the best strategies available to reduce the poor compliance of patients with antidepressant drugs. Patients' compliance will be measured within six months of pharmacological treatment, comparing the specific contributions of brief psychotherapy and psychoeducational interventions: the psychoeducational intervention will encompass the monitoring of drugs' side effects and patients' satisfaction. In the rest of the document, for the sake of brevity the two treatments previously described will be indicated as "psychotherapy" and "psychoeducation". These treatments will be compared with the treatment usually carried on by the mental health centers involved (i.e. treatment as usual, TAU). The factorial design of the study will take into consideration the combination of the two treatments (i.e. psychotherapy and psychoeducation) as well.
详细描述
Another important aim of the study is the investigation of whether the clinical improvement depends on the efficacy of the psychological treatments proposed per se, or whether they just contribute to increase the compliance with the pharmacological treatment, maintaining the patients on treatment longer and allowing the drugs to reach long-lasting effects. While recognizing the general therapeutic efficacy of psychotherapy in the treatment of depressive disorders, nevertheless the present study aims at verifying whether an equal therapeutic effect may be reached via a better compliance with the pharmacological treatment, fostered for example by the psychoeducational intervention. The rationale lays on the ease of transferability of psychoeducational interventions to the general clinical practice, that usually suffers from lack of resources in implementing structured psychotherapy interventions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New episode of depression, according to the DSM-IV (Codes F32 Major Depressive Disorder, single episode; F33 Major Depressive Disorder, recurrent; F34.1 Dysthymic Disorder; F32.9 Depressive Disorder, not otherwise specified), or new contact with the Mental Health Center for recurrent depression (same Codes) after a six-month period (or longer) without any treatment;
- •Age >= 18 years old;
- •QIDS-SR16 score >=10;
- •Necessity of a pharmacological antidepressant treatment;
- •Written informed content given by the participant before the beginning of the study.
排除标准
- •Comorbidity of schizophrenic disorder, according to the DSM-IV (Codes F06.3 - Organic mood disorder; F20 - Schizophrenia; F29 -Uunspecified Nonorganic Psychosis; F30-F31 - Manic Episode and Bipolar Affective Disorder; F34.0 - Cyclothymia; F10-F19 - Mental and Behavioural Disorders due to Psychoactive Substance Use).
- •Current pregnancy.
- •Probable hospitalization, for whatever reason.
- •Patient seen once and then referred to his/her GP or other specialist physician;
- •Pharmacological treatment already prescribed by a psychiatry or neurology specialist. However, if the patient is not satisfied with the current treatment and/or the psychiatrist involved in the present study considers appropriate to change the treatment, the present exclusion criterion will not be valid any longer.
- •Pharmacological treatment prescribed for more than 15 days by patient's GP. However, if the patient is not satisfied by the treatment and/or the psychiatrist involved in the present study considers appropriate to change the treatment, the present exclusion criterion will not be valid any longer.
- •The patient is currently under psychotherapy.
结局指标
主要结局
Proportion of patients showing good compliance, as measured at six months from the beginning of the treatment.
时间窗: 3 years
The effect size is conceptualized as the difference between the proportion of patients in the 4 treatment arms showing good compliance at the end of the study. The effects of the two treatments (psychotherapy and psychoeducation) will be measured separately, via stratified analyses and multivariate regression models, as appropriate.
次要结局
未报告次要终点