Acupuncture Augmentation Therapy for In-hospital Patients With Major Depression Disorder: a Pragmatic, Randomized Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 84
- 试验地点
- 1
- 主要终点
- Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
研究概览
简要总结
Acupuncture practice is based on Traditional Chinese Medicine (TCM) principles of harmonization and balance, and the need to maintain unobstructed flow of energy (Qi) to attain efficient body functioning and metabolism so as to attain good mental and physical state of health. While increasing numbers of patients are seeking acupuncture treatment for depression in recent years, there is limited evidence of the effectiveness of acupuncture for in-hospital patients with severe depressive conditions and comorbid cognitive dysfunction, who need intensive antidepression care.
In this study, we propose a randomized clinical trial to test the clinical efficacy of acupuncture treatment for in-hospital patients who are suffering from major depressive disorder. A total of 84 patients will be 1:1 randomly assigned to 1 of 2 groups in a single-blind randomized controlled trial. The specific intervention arm involved daily augmentation TCM-style acupuncture with manual stimulation for total 10 sessions; the control arm is consisted of patients with treatment as usual (TAU), i. e. waitlist condition who will receive standard antidepressant medication with or without psychotherapies. Patients in TAU arm will be offered one free course (total 10 sessions) of acupuncture treatment in TCM outpatient clinic after they have been discharged from the ward. All patients' depressive symptoms, cognitive function, quality of life and functioning will be assessed and compared at pre-treatment (baseline), immediately after in-hospital acupuncture treatment, one-month post-treatment and 3-month post-treatment. In addition, we will analyze the association of sociodemographic and clinical characteristics with the treatment effect of acupuncture.
This study will be the first study to examine whether acupuncture is a viable augmentation treatment for in-hospital patients with depression. Expected outcomes will include determining the relative short and medium-term clinical effects from the most commonly used acupuncture treatment modalities in a local and multiethnic population.
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 (Outcomes Assessor)
盲法说明
Outcome assessor blinded to treatment allocation
入排标准
- 年龄范围
- 21 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age ≥21 years.
- •DSM-V diagnosis of current Major Depressive Episode.
- •Montgomery-Asberg Depression Rating Scale score of 20 or more.
- •Able to give informed consent.
排除标准
- •History of psychosis or mania
- •With current ECT or neurostimulation treatment.
- •With severe heart or renal condition
- •Currently taking blood thinning drug including Aspirin etc.
- •Endocrine abnormalities (e.g., hypothyroidism, unstable diabetes);
- •History of central nervous system involvement (e.g., seizures, brain injury, neurologic ill- ness);
研究组 & 干预措施
Acupuncture
干预措施: Acupuncture (Device)
Treatment as usual
干预措施: Treatment as usual (Other)
结局指标
主要结局
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
时间窗: 3 months post treatment
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.(scored 0 to 60 with higher scores meaning worse outcome)
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
时间窗: 2 week post treatment
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorder (scored 0 to 60 with higher scores meaning worse outcome)
Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered).
时间窗: 1 month post treatment
MADRS is a ten-item diagnostic questionnaire which psychiatrists use to measure the severity of depressive episodes in patients with mood disorders.(scored 0 to 60 with higher scores meaning worse outcome)
次要结局
- TCM Assessment Form (Depression)(2 weeks, 1 month, 3 months post treatment)
- Montreal Cognitive Assessment (MoCA) (clinician administered).(2 weeks, 1 month, 3 months post treatment)
- Quick Inventory of Depressive Symptomatology- Self report 16 items (QIDS-SR16) (subjective, self-administered)(2 weeks, 1 month, 3 months post treatment)
- Global Assessment of Functioning (GAF) (clinician administered)(2 weeks, 1 month, 3 months post treatment)
- EQ-5D (self-administered)(2 weeks, 1 month, 3 months post treatment)