Acupuncture Augmentation for Inpatients With Major Depression Disorder

Study Overview
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Brief Summary
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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.

Official Title
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Acupuncture Augmentation Therapy for In-hospital Patients With Major Depression Disorder: a Pragmatic, Randomized Controlled Trial

Conditions
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Depression

Intervention / Treatment
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* Device: Acupuncture
* Other: Treatment as usual


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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); Pregnancy.

Ages Eligible for Study
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Minimum Age: 21 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Randomized single blinded controlled trial
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Acupuncture<br> | Device: Acupuncture<br>* Unilateral and bilateral acupuncture points: Du 20 and GV 29,39 MS1, MS2, MS3 and MS4,40 Location of points: Number of needles: 9 Depth of insertion: MS1, MS2, MS3: insert the needle obliquely in the frontal direction for 1 cm Du 20: insert the needle obliquely in the frontal direction for 0.5 cm GV 29: insert the needle obliquely and downward for 0.5 cm Needles retained for 20 min Needle type: Han Yi 0.25x25 mm Treatment regimen: once per day for 2 weeks<br>|
| Active Comparator: Treatment as usual<br> | Other: Treatment as usual<br>* Inpatient psychiatric care for depression<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered). | 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) | 2 week post treatment | 
| Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered). | 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) | 1 month post treatment | 
| Montgomery-Åsberg Depression Rating Scale (MADRS) (objective, clinician administered). | 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) | 3 months post treatment | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Montreal Cognitive Assessment (MoCA) (clinician administered). | MoCA was validated in the setting of mild cognitive impairment,44 and has subsequently been adopted in numerous other settings clinically. (scored 0 to 30 with higher scores indicating better outcome) | 2 weeks, 1 month, 3 months post treatment | 
| EQ-5D (self-administered) | EQ-5D is a standardized measure of health-related QoL developed by the EuroQol Group to provide a simple, generic questionnaire for use in clinical and economic appraisal and population health surveys | 2 weeks, 1 month, 3 months post treatment | 
| Quick Inventory of Depressive Symptomatology- Self report 16 items (QIDS-SR16) (subjective, self-administered) | The QIDS-SR16 has highly acceptable psychometric properties, which supports the usefulness of this brief rating of depressive symptom severity in both clinical and research settings | 2 weeks, 1 month, 3 months post treatment | 
| Global Assessment of Functioning (GAF) (clinician administered) | GAF is a scoring system that mental health professionals use to assess how well an individual is functioning in their daily lives (Scored 0-100 with higher score indicating better outcomes) | 2 weeks, 1 month, 3 months post treatment | 
| TCM Assessment Form (Depression) |  | 2 weeks, 1 month, 3 months post treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Acupuncture