Discontinuation of Antidepressant Medication in Primary Care Supported by Monitoring Plus Mindfulness-based Cognitive Therapy Versus Monitoring Alone.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 119
- 试验地点
- 2
- 主要终点
- Number of patients who fully discontinued their antidepressant medication after 6 months.
研究概览
简要总结
To investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and Mindfulness-Based Cognitive Therapy (MBCT) in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.
详细描述
Antidepressant use continues to rise, mainly explained by an increase in the proportion of patients receiving long term treatment. Although treatment guidelines recommend discontinuation after sustained remission, discontinuing antidepressants appears to be challenging for both patients and general practitioners. Mindfulness-Based Cognitive Therapy (MBCT) is an effective intervention that reduces the risk of relapse in recurrent depression and might facilitate discontinuation by teaching patients to cope with withdrawal symptoms and fear of relapse. The current study aims to investigate the effectiveness of the combination of Supported Protocolized Discontinuation (SPD) and MBCT in comparison with SPD alone in successful discontinuation of long-term use of antidepressants in primary care.
Methods/Design This study involves a cluster-randomized controlled trial conducted in primary care patients with long-term use antidepressants with baseline and 6, 9 and 12 months follow-up assessments. Patients choosing to discontinue their medication will be offered a combination of supported protocolized discontinuation (SPD) and MBCT or SPD alone. Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Secondary outcome measures will be the severity of withdrawal symptoms, symptoms of depression and anxiety, psychological well-being, quality of life and medical and societal costs.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Having received prescriptions for antidepressants in primary care for at least the past nine months
排除标准
- •Current treatment by a psychiatrist
- •Current diagnosis of substance use disorder
- •Non-psychiatric indication for long-term antidepressant usage (i.e. neuropathic pain)
- •Having participated in a mindfulness training (> 3 sessions) within the last 5 years
- •Inability to perform the assessments due to cognitive or language difficulties
- •Younger than 18 years
结局指标
主要结局
Number of patients who fully discontinued their antidepressant medication after 6 months.
时间窗: 6 months
Our primary outcome will be full discontinuation of antidepressant medication (= 0 mg) within 6 months after baseline assessment. Use of medication will be measured with daily calendars. Patients daily fill out paper calendars describing their daily milligrams of their antidepressant use.
次要结局
- State/Trait Anxiety Inventory(baseline and 6, 9 and 12 months)
- Inventory of Depressive Symptomatology(baseline and 6, 9 and 12 months)
- Structured Clinical Interview for DSM-IV-TR Disorders(baseline and 6, 9 and 12 months)
- Module Suicide Cognitions of the Mini International Neuropsychiatric Interview(baseline and 6, 9 and 12 months)
- Five Facet Mindfulness Questionnaire(baseline and 6, 9 and 12 months)
- Discontinuation-Emergent Signs and Symptoms(baseline and 6, 9 and 12 months)
- Self-Compassion Scale(baseline and 6, 9 and 12 months)
- Mental Health Continuum - short form(baseline and 6, 9 and 12 months)