Effectiveness of Screening and Counselling for Elderly With Psychological Problems
Primary Purpose
Mental Illness
Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Brief counselling
Behavior
Sponsored by
About this trial
This is an interventional treatment trial for Mental Illness focused on measuring Mental health, Screening, Elderly, Chinese, Problem-solving counselling
Eligibility Criteria
Inclusion Criteria: Aged 60 or above Attending the study primary care clinic No known diagnosis of psychological problem Written consent provided Exclusion Criteria: Known psychological disease diagnosed by a registered practitioner Taking any psychotropic drug prescribed by a registered practitioner of Western medicine within the last year; Has suicidal plan or strong suicidal thought; Has psychotic symptom; any impairment in cognitive function; or any communication problem refuses to participate
Sites / Locations
Outcomes
Primary Outcome Measures
Health-related quality of life scores
Hospital Anxiety and Depresssion scores
Secondary Outcome Measures
Consultation rates
Full Information
NCT ID
NCT00283270
First Posted
January 26, 2006
Last Updated
January 26, 2006
Sponsor
The University of Hong Kong
Collaborators
The Health Care and promotion Fund, the Governement of the Hong Kong SAR.
1. Study Identification
Unique Protocol Identification Number
NCT00283270
Brief Title
Effectiveness of Screening and Counselling for Elderly With Psychological Problems
Official Title
A Randomised Controlled Trial on the Effectiveness of Screening and Brief Counselling for Elderly Patients With Psychological Problems in Primary Care.
Study Type
Interventional
2. Study Status
Record Verification Date
December 2005
Overall Recruitment Status
Completed
Study Start Date
November 2002 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
August 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
The University of Hong Kong
Collaborators
The Health Care and promotion Fund, the Governement of the Hong Kong SAR.
4. Oversight
5. Study Description
Brief Summary
The aim of the study is to test whether screening followed by brief problem-solving counselling in primary care could improve the quality of life of elderly patients with undiagnosed psychological problems. We hypothesize that undiagnosed psychological problems detectable by screening are common in the elderly and brief counselling could improve the quality of life of these patients.
Detailed Description
Objectives: The aim of the study is to test if screening followed by brief problem-solving counselling by primary care doctors can improve the health-related quality of life (HRQOL) of elderly patients with previously undiagnosed psychological problems. It will also find out the effects of undiagnosed psychological problems on HRQOL and consultation rates of elderly patients.
Design, Setting & Subjects: This is a prospective single-blinded randomised controlled trial on 450 patients aged 60 or above attending a Government General Outpatient Clinic in Hong Kong, who have been screened for psychological problems.
Methods: Elderly patients attending the General Outpatient Department of the Ap Lei Chau Clinic who are not known to have the diagnosis of psychological problems with the Hospital Anxiety & Depression Scale (HADS) were screened in order to recruit 300 subjects who are screened positive for undiagnosed psychological problems will be randomised into the counselling or no-counselling groups, and 150 subjects who are screened negative for psychological problems will be selected as normal controls
Interventions: The counselling group will receive brief problem-solving counselling from a trained primary care doctor in addition to their usual medical care; the no-counselling group will receive general health education and their usual medical care; and the normal control group will continue with their usual care only.
Main Outcome Measures: Health-related quality of life measured by the SF-36, the HADS scores and consultation rates. The baseline and changes in outcomes of the three groups will be compared at 0, 6, 12, 36 and 52 weeks after screening.
Conclusions: The results will provide evidence on whether screening followed by brief problem-solving counselling in primary care is effective in improving quality of life and reducing consultation rates for the elderly with undiagnosed psychological problems.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mental Illness
Keywords
Mental health, Screening, Elderly, Chinese, Problem-solving counselling
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
Single
Allocation
Randomized
Enrollment
450 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Brief counselling
Intervention Type
Behavioral
Intervention Name(s)
Behavior
Primary Outcome Measure Information:
Title
Health-related quality of life scores
Title
Hospital Anxiety and Depresssion scores
Secondary Outcome Measure Information:
Title
Consultation rates
10. Eligibility
Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Aged 60 or above
Attending the study primary care clinic
No known diagnosis of psychological problem
Written consent provided
Exclusion Criteria:
Known psychological disease diagnosed by a registered practitioner
Taking any psychotropic drug prescribed by a registered practitioner of Western medicine within the last year;
Has suicidal plan or strong suicidal thought;
Has psychotic symptom;
any impairment in cognitive function; or
any communication problem
refuses to participate
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Cindy L Lam, MD
Organizational Affiliation
The University of Hong Kong
Official's Role
Principal Investigator
12. IPD Sharing Statement
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Effectiveness of Screening and Counselling for Elderly With Psychological Problems
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