Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12614000378628
Ethics application status
Approved
Date submitted
31/03/2014
Date registered
8/04/2014
Date last updated
8/04/2014
Type of registration
Prospectively registered

Titles & IDs
Public title
Impact of Positive Psychology Group Intervention for Chronic Illness Patients with negative emotional states in Primary Care– A Prospective Experimental Study
Scientific title
Impact of Positive Psychology Group Intervention for Chronic Illness Patients with negative emotional states in Primary Care– A Prospective Experimental Study
Secondary ID [1] 284366 0
none
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Patient with diabetes and/or hypertension with negative emotions screened using DASS-21 291529 0
Condition category
Condition code
Metabolic and Endocrine 291904 291904 0 0
Diabetes
Cardiovascular 291905 291905 0 0
Hypertension
Mental Health 291906 291906 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This prospective case studies will conduct a 6-weekly 2-hr session group intervention program for 15 patients with stable hypertension and/or diabetes on regular follow-up at a primary care clinic. The waiting list of 15 patients for this intervention study will be used as the control. This program will adopt multiple component interventions focusing on the several well-studied areas of positive psychology. The multi-skills including noticing the positives, character strength, gratitude, optimism, hope and mindfulness will be conducted in 6 weekly sessions. A Family physician who has training in counselling and positive psychology will administer this intervention
Intervention code [1] 289095 0
Treatment: Other
Comparator / control treatment
15 patients awaiting the 6-weekly 2hrly session of positive psychology intervention will be used as the control
Control group
Active

Outcomes
Primary outcome [1] 291820 0
Change in DASS-21, Life Satisfaction Scale and Subjective Happiness Index pre and post-intervention
Timepoint [1] 291820 0
6 week post-intervention
Secondary outcome [1] 307609 0
none
Timepoint [1] 307609 0
none

Eligibility
Key inclusion criteria
Inclusion Criteria:
1). Patients aged 40 and above with hypertension and/or diabetes mellitus and they are screened to have negative emotional states using Chinese version of Depression, Anxiety, Stress Scale DASS-21
2). They are willing and able to participate in 6-weekly, 2hr/week Positive Psychology Intervention Program
Minimum age
40 Years
Maximum age
90 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Exclusion Criteria :
1). Patients with history of major psychiatric disorders such as major depression, schizophrenia, panic disorder and etc.
2). Patients currently on psychoactive medications.
3). Patients with cognitive impairment or acute exacerbation of chronic medical illness.

Study design
Purpose of the study
Treatment
Allocation to intervention
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed
Using the Clinical Management System CMS, patients with chronic medical disease will be identified and their appointment dates searched. On day of patient’s appointment, she/he will be screened on voluntary basis for depression, anxiety and stress using DASS-21 Chinese version. Patients screened to have negative emotional states with scores of Depression >4 and/or Anxiety>3 and/or Stress>7 will be invited to join this intervention. If patient agrees to join the study, informed consent will be signed. A convenient sampling of 30 eligible subjects will be recruited to account for 25% attrition rate. The 6-weekly 2-hr session group intervention will consist of 15 subjects. The other 15 subjects in the waiting list will be the control group.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Convenient sampling and allocation is not randomised
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
According to Browne ( Browne 1995); Lancaster et al ( Lancaster 2002); Ross-McGill et al 2000); Stevinson&Ernst 2000), a pilot study recruiting at least 30 subjects is suggested to determine initial data for the primary outcome measure, in order to perform a sample size calculation for a larger trial, Thus, we aimed to recruit 30 subjects for this pilot study

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
10/04/2014
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
30
Accrual to date
Final
Recruitment outside Australia
Country [1] 5945 0
Hong Kong
State/province [1] 5945 0
Hong Kong

Funding & Sponsors
Funding source category [1] 289044 0
Self funded/Unfunded
Name [1] 289044 0
Lorna Ng
Country [1] 289044 0
Hong Kong
Primary sponsor type
Individual
Name
Lorna Ng
Address
Family Medicine and General Out-Patient Clinic
Kwong Wah Hospital
Waterloo Road
Kowloon, Hong Kong
Country
Hong Kong
Secondary sponsor category [1] 287686 0
None
Name [1] 287686 0
Not applicable
Address [1] 287686 0
Country [1] 287686 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 290817 0
Kowloon West Cluster Research Ethics Committee
Ethics committee address [1] 290817 0
Ethics committee country [1] 290817 0
Honduras
Date submitted for ethics approval [1] 290817 0
Approval date [1] 290817 0
27/03/2014
Ethics approval number [1] 290817 0
KWC REC 71-35

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 47366 0
Dr Lorna Ng
Address 47366 0
Family Medicine and General Out-Patient Department
Kwong Wah Hospital
Waterloo Road
Kowloon, Hong Kong
Country 47366 0
Hong Kong
Phone 47366 0
+852 35172310
Fax 47366 0
Email 47366 0
[email protected]
Contact person for public queries
Name 47367 0
Lorna Ng
Address 47367 0
Family Medicine and General Out-Patient Department
Kwong Wah Hospital
Waterloo Road
Kowloon, Hong Kong
Country 47367 0
Hong Kong
Phone 47367 0
+852 35172310
Fax 47367 0
Email 47367 0
[email protected]
Contact person for scientific queries
Name 47368 0
Lorna Ng
Address 47368 0
Family Medicine and General Out-Patient Department
Kwong Wah Hospital
Waterloo Road
Kowloon, Hong Kong
Country 47368 0
Hong Kong
Phone 47368 0
+852 35172310
Fax 47368 0
Email 47368 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.