Acupuncture Augmentation for Inpatients With Major Depression Disorder

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

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.

Study Overview

• Status: Recruiting
• Conditions: Depression
• Intervention / Treatment: Device: Acupuncture; Other: Treatment as usual

• Study Type: Interventional
• Enrollment (Anticipated): 84
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Phern Chern Tor, MBBS; Phone Number: 63892000; Email: phern_chern_tor@imh.com.sg

Study Locations

• Singapore
  • Singapore, Singapore, 539747
    • Recruiting
    • Institute of Mental Health
    • Contact: Phern Chern Tor, MBBS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 21 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age ≥21 years.
2. DSM-V diagnosis of current Major Depressive Episode.
3. Montgomery-Asberg Depression Rating Scale score of 20 or more.
4. Able to give informed consent.

Exclusion Criteria:

1. History of psychosis or mania
2. With current ECT or neurostimulation treatment.
3. With severe heart or renal condition
4. Currently taking blood thinning drug including Aspirin etc.
5. Endocrine abnormalities (e.g., hypothyroidism, unstable diabetes);
6. History of central nervous system involvement (e.g., seizures, brain injury, neurologic ill- ness);
7. Pregnancy.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Treatment as usual	Other: Treatment as usual; Inpatient psychiatric care for depression
Experimental: Acupuncture	Device: Acupuncture; 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

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Institute of Mental Health, Singapore
• Collaborators: Nanyang Technological University
• Investigators: Principal Investigator: Phern Chern Tor, MBBS, Institute of Mental Health, Singapore

Study record dates

Study Major Dates

• Study Start (Actual): June 24, 2022
• Primary Completion (Anticipated): May 31, 2025
• Study Completion (Anticipated): May 31, 2025

Study Registration Dates

• First Submitted: June 24, 2022
• First Submitted That Met QC Criteria: July 7, 2022
• First Posted (Actual): July 11, 2022

Study Record Updates

• Last Update Posted (Actual): July 11, 2022
• Last Update Submitted That Met QC Criteria: July 7, 2022
• Last Verified: July 1, 2022

More Information

Terms related to this study

• Keywords: Acupuncture
• Additional Relevant MeSH Terms: Behavioral Symptoms; Mental Disorders; Mood Disorders; Depression; Depressive Disorder
• Other Study ID Numbers: IMHSingapore

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No