Centre For Clinical Research And Biostatistics (CCRB)

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1 Unique Trial Number (assigned by CCRB)

CUHK_CCRB00500

2 Trial Registration Date

2016-01-20

i Registration Status

Prospective

3 Secondary IDs

3-1-201504_03

4 Source(s) of Funding

The Hongkong and Shanghai Banking Corporation Limited through the Community Chest of Hong Kong

5 Primary Sponsor

City University of Hong Kong

6 Secondary Sponsor

Hong Kong Family Welfare Society

Function

Take on all the responsibilities of sponsorship jointly with the primary sponsor

Please specify

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

i Name

Hay Ming Herman Lo

ii Address

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong

iii Phone

34428116

iv Email

hm.lo@cityu.edu.hk

v Affiliation

Department of Applied Social Sciences, City University of Hong Kong

vi Country

Hong Kong

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

i Name

Hay Ming Herman Lo

ii Address

B7409, AC1, City University of Hong Kong, Tat Chee Avenue, Kowloon Tong

iii Phone

34428116

iv Email

hm.lo@cityu.edu.hk

v Affiliation

Department of Applied Social Sciences, City University of Hong Kong

vi Country

Hong Kong

9 Official Scientific Title of the Study

Evidence-based Practice on Working with Depression in Older Adults

10 Public Title

Smiley Activation Project - Community/Home-based Depression Treatment for the Elderly

i Public Title in Chinese 研究名稱

「躍動晚情」抗抑鬱個人管理計劃

11 Short Title (Optional)

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?

2015-06-01

iii Full Name of IRB/IEC

Other

Please specify

Research Grants & Contracts Office, City University of Hong Kong

iv IRB/IEC approval reference number

3-1-201504_03

14 Medical Condition Being Studied

depression

15 Intervention

i Types of intervention

Other

Please specify

Problem solving treatment and behavioral activation

ii Description/ name of Intervention/article

It is a community-based treatment program using methods of problem solving treatment and behavioral activation to reduce depression in older adults with minor depression or dysthymia.

Problem-solving treatment is a brief, practical psychological treatment which helps participants to identify and solve problems.

Behavioral activation is a behavioral treatment that primarily focuses on increasing rewarding activities, overcoming avoidance living patterns, and re-establishing healthy life routines through pleasant activity scheduling.

iii Dosage form of the intervention

Talk and behavioral psychotherapy

iv Dosage of the intervention

There would be four to eight sessions over a period of no more than six months.

v Duration of the intervention

About 1 hour per session

vi Frequency of the intervention

Session 1 to 3: weekly; 4 to 5: biweekly; 6 to 8: monthly

16 Comparative Treatments

i Description/ name of comparative treatments

Treatment as usual

ii Dosage form of the comparative treatments

NA

iii Dosage of the comparative treatments

NA

iv Duration of the comparative treatments

NA

v Frequency of the comparative treatments

NA

17 Key Inclusion and Exclusion Criteria

i Inclusion Criteria

60 years of age or over

Having minor depression or dysthymic disorder

ii Exclusion Criteria

Meeting criteria for major depression

Diagnosis of a psychiatric disorder (e.g., bipolar disorder and psychotic disorder)

Having substance abuse

Having cognitive decline

iii Age Minimum

60

iv Age Maximum

80

v Gender

Both Male and Female

18 Study Type

Interventional

19 Study Design

i Randomization

Non-randomized

Please specify

ii Nature of control

Not Applicable

iii Degree of masking

Open label

If Single-blind, who will be masked?

iv Group Assignment

Single group

v Study Phase

2

Please specify

vi Study Objectives (Optional)

20 Anticipated trial start date

2016-02-01

21 Target Sample Size

30 to 40

22 Recruitment Status

Not Yet Recruiting

23 Primary Outcome

i The Name of the outcome

Depression

ii The metric or method of measurement used

Questionnaire: Patient Health Questionnaire (PHQ-9)

iii The timepoint(s) of primary interest

Pre-test before intervention, mid-term evaluation, post-test after intervention and follow-up evaluation

24 Secondary Outcome

i The Name of the outcome

Level of social activity

ii The metric or method of measurement used

Questionnaire: Original PEARLS questionnaire

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Secondary Outcome

i The Name of the outcome

Level of physical activity

ii The metric or method of measurement used

Questionnaire: Rapid Assessment of Physical Activity (RAPA)

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Secondary Outcome

i The Name of the outcome

Level of pleasant activity

ii The metric or method of measurement used

Questionnaire: Original PEARLS questionnaire

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

Secondary Outcome

i The Name of the outcome

General self-efficacy

ii The metric or method of measurement used

Questionnaire: General Self-Efficacy Scale

iii The timepoint(s) of primary interest

Pre-test before intervention, post-test after intervention and follow-up evaluation

25 Study Information/Publication

i Study Information/Publication Available?

No

ii Link to Study Information/Publication

26 Last Update Date

2016-04-01

27 Primary Registry and Trial Identifying Number

28 Date of Registration in Primary Registry

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Trial History Detail on 2016-01-20