- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00863031
A Trial on the Effectiveness of Screening and Brief Problem-Solving Therapy (PST) for Elderly Patients With Psychological Problems
March 16, 2009 updated by: The University of Hong Kong
A Randomised Controlled Trail on the Effectiveness of Screening and Brief Counselling (Problem-Solving Therapy) for Elderly Patients With Psychological Problems in Primary Care.
The aim of this study was to determine whether screening followed by brief PSC provided by primary care doctors could improve the quality of life of elderly patients with unrecognized psychological problems in primary care. The following hypotheses were tested:
- Elderly patients screened positive of psychological problems had poorer health-related quality of life (HRQOL) than those who were screened negative.
- Primary care doctors could be trained to provide brief PST.
- Brief PST by a trained primary care doctor could improve the HRQOL of the elderly who were screened positive for psychological problems.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Design & methods: A prospective single-blind randomised controlled trial (RCT) on 299 patients aged 60 or above without any known psychological diseases but screened positive for psychological problems by the Hospital Anxiety and Depression Scale (HADS).
Subjects were randomised to problem-solving (PST) or video-viewing (placebo).
All subjects continued with their usual care and were followed up by telephone at 6, 12, 26 and 52 weeks.Changes in SF-36 HRQOL scores, HADS scores and monthly consultation rates at 6, 12, 26 and 52 weeks within groups and between groups.
Study Type
Interventional
Enrollment (Actual)
299
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
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Hong Kong, Hong Kong
- Two General Outpatient Clinics
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
60 years and older (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Aged 60 or above
- not known to have any psychological problem
- HADS Depression score 6 or above, or Anxiety Score 3 or above
- Written consent to study
Exclusion Criteria:
- known psychological disease diagnosed by a registered doctor
- history of taking any psychotropic drug prescribed by a registered doctor within the last year;
- suicidal plan or strong suicidal thought;
- psychotic symptom;
- impairment in cognitive function; or
- communication problem.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: problem-solving therapy
Three sessions of brief problem-solving counselling at week 1, 3 and 5 by a family doctor.
|
Three sessions of problem-solving therapy at week 1, 3 and 5.
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Placebo Comparator: viewing video
Three sessions of health education viewing video in groups of 3 to 5 people
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Three sessions of viewing health educational videos.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Health-related quality of life scores
Time Frame: 6, 12, 26 and 52 weeks
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6, 12, 26 and 52 weeks
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Hospital Anxiety & Depression Scale scores
Time Frame: 6, 12, 26 and 52 weeks
|
6, 12, 26 and 52 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Cindy L.K. Lam, MD, Family Medicine Unit, Faculty of Medicine, HKU
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- Lam C.L.K., Lee P.W.H., Fong D.Y.T. and Lam T.P., A randomised controlled trial on the effectiveness of screening and brief problem-solving counselling for elderly patients with undiagnosed psychological problems in primary care., Hong Kong Medical Journal. HK Academy of Medicine Press, 2008, 14: 31-35.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
November 1, 2002
Primary Completion (Actual)
December 1, 2005
Study Completion (Actual)
June 1, 2006
Study Registration Dates
First Submitted
March 15, 2009
First Submitted That Met QC Criteria
March 16, 2009
First Posted (Estimate)
March 17, 2009
Study Record Updates
Last Update Posted (Estimate)
March 17, 2009
Last Update Submitted That Met QC Criteria
March 16, 2009
Last Verified
March 1, 2009
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- HKCTR-497
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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