Mindfulness-based and Compassion-based Interventions in Anxious-Depressive Symptomatology in Mental Health Services: A Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 90
- 试验地点
- 1
- 主要终点
- Depression Anxiety Stress Scales
研究概览
简要总结
The aim of this study is to assess and compare the benefits of twopsychological interventions added to the usual treatment of patients whocome to mental health. Patients will be randomly assigned to the followingconditions: Mindfulness-Based Stress Reduction (MBSR), Attachment-BasedCompassion Therapy (ABCT) and a Treatment As Usual (TAU) Group. Theparticipants in the two psychological intervention groups will also receive usualpsychological/psychiatric treatment managed by their specialist. Mindfulnessand Compassion groups will be composed of 33 participants each, and TAU group will be composed of 64 participants (total sample n = 130).
The principal hypothesis is that 'ABCT + TAU' will be more effective than'MBSR + TAU' for treating depressive and/or anxiety symptoms in patients attending mental health settings. Secondary hypothesis are: 1) 'MBSR + TAU'and 'ABCT + TAU' will be more effective than 'TAU alone' for treatinganxiety and/or depressive symptoms in patients attending mental health settings; 2) mindfulness will be a mediator of the 'MBSR + TAU' program improvements, while self-compassion will be a mediator of the corresponding'ABCT + TAU'; and 3) 'ABCT + TAU' will present more cost-effectiveness than 'MBSR + TAU' and both ABCT + TAU' and 'MBSR + TAU' programs will present more cost-effectiveness than TAU alone.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age: 18-75 years old.
- •Depressive and/or anxious disorder, or adjustment disorder with depressive or/and anxious symptomatology, according to clinical criteria based on Diagnostic and Statistical Manual of Mental Disorders (DSM-5).
- •Disorder of mild or moderate severity according to clinical criteria (based on DSM-5).
- •Understand perfectly spoken and written Spanish.
- •Grant a written informed consent form
排除标准
- •To have done any type of meditative/contemplative practice during the previous year.
- •Any diagnose of disease that may affect central nervous system (brain pathology, traumatic brain injury, dementia, etc.).
- •Other psychiatric diagnoses or acute psychiatric illness (substance dependence or abuse, history of schizophrenia or other psychotic disorders, eating disorders, etc.).
- •Any medical, infectious or degenerative disease that may affect mood.
- •Presence of delusional ideas or hallucinations consistent or not with mood, and suicide risk.
研究组 & 干预措施
TAU
Usual specialized treatment in mental health (psychological or/and psychiatric)
干预措施: TAU (Other)
结局指标
主要结局
Depression Anxiety Stress Scales
时间窗: Six-months follow-up
In the MBSR based intervention group. This scale is a set of three self-report scales designed to measure the emotional states of depression, anxiety and stress. Each of the three DASS-21 scales contains 7 items, divided into subscales with similar content. The range for each subescale is 0-21 (But this scores will need to be multiplied by 2 to calculate the final score). This questionnaire also gives us a one-dimensional global measure of emotional distress that will be considered as the main study outcome. It is composed by all the 21 items configuring a general factor, and it will be taken as a continuous dimensional variable that ranges from 0 to 126.
次要结局
- Client Service Receipt Inventory (CSRI)(Six-months follow-up)
- Sociodemographic data such as gender, age, marital status, education, occupation, economical level(Baseline)
- Self-Compassion Scale(Six-months follow-up)
- Five Facet Mindfulness Questionnaire(Six-months follow-up)
- EuroQol-5D. Health related quality of life(Six-months follow-up)
研究者
Javier Garcia Campayo
Principal Investigator
Hospital Miguel Servet