Mindfulness-based Group Treatment of Patients With Depression and Anxiety: Effects on Symptoms and Inflammatory Markers in a Randomized Controlled Multicenter Study in Primary Care
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 215
- 主要终点
- Depression symptoms
研究概览
简要总结
The purpose of this study is to determine the effectiveness, with respect to symptoms and systemic inflammatory level, of mindfulness-based group treatment compared with normal treatment in patients diagnosed with minor to moderate mental disorders. The hypothesis is that mindfulness group-treatment 1) will be at least as effective as normal treatment in reducing psychiatric symptoms; 2) will increase quality of life compared with normal treatment; 3) will be costeffective compared with normal treatment; and 4) will reduce inflammation-related markers. The study will be conducted at primary care centers in Skåne, Sweden. We will assess the effect of mindfulness-based group treatment on psychiatric symptoms, quality of life, and health (as rated by the patients themselves) as well as inflammatory markers.
详细描述
Modern cognitive behavioral therapy (CBT) has since the 1990s involved mindfulness, a meditation-based technique that teaches patients to manage their thoughts and feelings. A problem with individual-based psychotherapies is that they are costly, and therapists educated in mindfulness are scarce. Here, we are seeking basis for healthcare providers in primary care to recommend group-based mindfulness training to patients with minor to moderate mental disorders.
Aims of the study:
The primary aim of this study is to assess the effectiveness of mindfulness-based group treatment of patients with minor to moderate mental disorders in primary care through comparison with patients who receive treatment as usual (controls). The cost-effectiveness of mindfulness-based group treatment as an alternative to individual CBT will also be studied. In addition, since increased systemic inflammation has been linked to mental disorders, the effects of the intervention on systemic inflammation-as measured by serum levels of well-established inflammatory and inflammation-related markers (proteins, miRNAs, SNPs, telomere length)-will also be evaluated. Finally, we intend to analyze gene-environment interactions to see if we can find characteristics in the neighbourhood environment that may predict the development of mental disorders in genetically susceptible individuals.
Parameters evaluated in the study:
Parameters assessed at baseline, before the intervention starts: Blood sampling (level of inflammation and inflammation-related markers); Daily functioning (the Global Assessment of Functioning (GAF) scale); Quality of life (the EQ-5D instrument); Symptom Checklist (SCL-90) instrument; self-rated health (a Swedish Survey of Living Conditions (ULF) question with 5 alternative answers); and mindfulness ability (the Mindfulness Attention Awareness Scale (MAAS)). Post-intervention: Blood sampling, Level of depression (as assessed using the Montgomery-Asberg Depression Rating Scale (MADRS-S); the Patient Health Questionnaire (PHQ-9); Anxiety level and stress reactions (the Hospital Anxiety and Depression (HAD) scale); as well as the above described GAF, EQ-5D, SCL-90, ULF and MAAS. Follow-up: the patients will be assessed by the PHQ-9, HAD, MADRS-S, EQ-5D, GAF, SCL-90, ULF and MAAS questionnaires 6, 12 and 24 months after the end of intervention. As a co-variate to the above described parameters, we will analyze Geographic Information System (GIS)-coordinates for neighbourhood social and physical characteristics.
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
- None
入排标准
- 年龄范围
- 20 Years 至 64 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Mental disorders: Mild depressive episode (ICD-10 code F32.0)
- •Moderate depressive episode (F32.1)
- •Depressive episode, unspecified (F32.9)
- •Recurrent depressive disorder, current episode mild (F33.0)
- •Recurrent depressive disorder, current episode moderate (F33.1)
- •Panic disorder (F41.0)
- •Generalized Anxiety Disorder (F41.1)
- •Mixed Anxiety and Depression Adjustment (F41.2)
- •Other mixed anxiety disorders (F41.3)
- •Other specified anxiety disorders (F41.8)
- •Anxiety disorders unspecified (F41.9)
- •Adjustment Disorder (F43.2)
- •Other reactions to severe stress (F43.8)
- •Reaction to severe stress, unspecified (F43.9)
- •Age: 20-64 years
- •Ability to speak Swedish
- •Daily access to the Internet
- •Score of ≥10 points on the PHQ-9 OR ≥7 points on the HAD scale OR between 13 and 34 points on the MADRS-S (mild to moderate depression)
排除标准
- •Serious depression/anxiety that needs psychiatric care
- •Personality disorders
- •Suicide risk (score of >4 on item 9 of the MADRS-S)
- •Ongoing treatment at a psychiatric clinic at the time of recruitment
- •Ongoing psychotherapy (e.g., CBT) at the time of recruitment
- •Current alcohol, prescription medicine or narcotic abuse
研究组 & 干预措施
Mindfulness-based group treatment
8 group mindfulness sessions (1 per week), complemented by home mindfulness exercises
干预措施: Mindfulness-based group treatment (Behavioral)
Treatment as usual
Treatment as usual (including individual CBT and medication)
结局指标
主要结局
Depression symptoms
时间窗: Week 8
MADRS-S total score after treatment
次要结局
- Self-rated health(8 weeks, 6, 12 and 25 months)
- Anxiety and depression symptoms(1 week after treatment and 6, 12, and 24 months after completion of the treatment)
- Depression symptoms(1 week after treatment, and 6, 12, and 24 months after completion of the treatment)
- Systemic inflammation(8 weeks)
研究者
Jan Sundquist
Professor Jan Sundquist
Lund University