Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCT00451

2 Trial Registration Date

2015-03-27

i Registration Status

Prospective

3 Secondary IDs

KW/EX-14-094(75-07(TCM))

4 Source(s) of Funding

Angel S.P. Chan Lau Endowed Fund

5 Primary Sponsor

School of Nursing, The Hong Kong Polytechnic University

6 Secondary Sponsor

Kwai Chung Hospital

Function

Please specify

7 Responsible Contact Person (public contact person for patients interested in participating)

i Name

Ryan Ngai

ii Address

A110, The Hong Kong Polytechnic University, HKSAR

iii Phone

34003797

iv Email

pak.yu.ryan.ngai@polyu.edu.hk

v Affiliation

The Hong Kong Polytechnic University

vi Country

8 Research Contact Person (person to contact for scientific inquiries)

i Name

Alex MOLASIOTIS

ii Address

GH507, School of Nursing, The Hong Kong Polytechnic University, HKSAR

iii Phone

2766-6396

iv Email

alex.molasiotis@polyu.edu.hk

v Affiliation

The Hong Kong Polytechnic University

vi Country

9 Official Scientific Title of the Study

The effectiveness of acupressure for the management of depressive symptoms and mental health problems in elderly people: a randomised controlled trial

10 Public Title

The effectiveness of acupressure for the management of depressive symptoms and mental health problems in elderly people: a randomised controlled trial

i Public Title in Chinese 研究名稱

隨機對照試驗：穴位按壓對老年抑鬱症狀和心理健康之有效性

11 Short Title (Optional)

Acupressure for depression in elderly people

12 Countries of Recruitment

Hong Kong

13 Research Ethic Review

i Has the study received appropriate ethics approval?

Yes

ii When is the approval date?

2014-10-03

iii Full Name of IRB/IEC

Please specify

iv IRB/IEC approval reference number

14 Medical Condition Being Studied

Depression

15 Intervention

i Types of intervention

Other

Please specify

Acupressure

ii Description/ name of Intervention/article

Acupressure

iii Dosage form of the intervention

iv Dosage of the intervention

v Duration of the intervention

12 weeks

vi Frequency of the intervention

16 Comparative Treatments

i Description/ name of comparative treatments

Sham acupressure and standard care.
Duration: 12 weeks.

ii Dosage form of the comparative treatments

iii Dosage of the comparative treatments

iv Duration of the comparative treatments

v Frequency of the comparative treatments

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

Patients with a diagnosis of depression or obvious features of depression as indicated by the Geriatric Depression Scale which will be used as screening tool.
Stable medication for past four weeks
Patients of either gender and older than 65 years old
Patients who are willing to participate in the study and be randomised into one of the three study groups
Patients who understand Cantonese or Putonghua or English

ii Exclusion Criteria

Older people with cognitive and language impairment or those unable to understand the questionnaires and study procedures and information.
Those who have wounds, abrasions and injuries on body parts where acupressure will be applied.
Those diagnosed as suffering from a terminal illness with a life expectancy of less than six months.
Ever receiving acupressure/acupuncture treatment within previous 6 months.

iii Age Minimum

65

iv Age Maximum

100

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Randomized

Please specify

ii Nature of control

Placebo

iii Degree of masking

Double-blind

If Single-blind, who will be masked?

iv Group Assignment

Parallel

v Study Phase

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2015-04-10

21 Target Sample Size

144

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

To assess the clinical effectiveness of acupressure in addition to standard care in the management of depression by GDS-short form. At baseline, 6 weeks, 12 weeks and 3 months post-intervention.

24 Secondary Outcome

The level of quality of life (by PSQI, WHOQOL), the clinical effectiveness of acupressure in addition to standard care in the management of mental health problems other than depression (by GHQ, BMSWBI), the impact of the intervention on caregivers and service providers, the changes of cohesiveness, relationship, family-harmonious and degree of intimacy between informal carers and elderly people living in the community (by Smilkstein’s Family System APGAR Items).
At baseline, 6 weeks, 12 weeks and 3 months post-intervention.

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2015-03-27

27 Primary Registry and Trial Identifying Number

ChiCTR-IPC-15006159

28 Date of Registration in Primary Registry

2015-03-28

* Legacy Fields

i Recruitment Information Available?

Yes

ii Link to Recruitment Information

n/a

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Trial History Detail on 2015-08-11