Mental IllnessPhase 4NCT00283270
Effectiveness of Screening and Counselling for Elderly With Psychological Problems
A Phase 4 study testing Brief counselling and Behavior in people with Mental Illness, run by The University of Hong Kong.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Mental Illness
- What is being tested?
- Brief counselling and Behavior
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 450 participants
- Where
- No sites listed yet
- Study dates
- Nov 2002to Aug 2005
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Aged 60 or above
- Attending the study primary care clinic
- No known diagnosis of psychological problem
- Written consent provided
Who cannot join
- 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
About this study
Official title: A Randomised Controlled Trial on the Effectiveness of Screening and Brief Counselling for Elderly Patients With Psychological Problems in Primary Care.
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.
Read the 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.
- Conditions
- Mental Illness
- Being tested
- Brief counselling, Behavior
- Keywords
- Mental health, Screening, Elderly, Chinese, Problem-solving counselling
- Medical subject headings
- Mental Disorders, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Brief counsellingBehavioural
BehaviorBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life scores
Hospital Anxiety and Depresssion scores
Secondary outcomes (1)
Consultation rates
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2006 (estimated)
- Study startNov 2002
- Study completionAug 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mental IllnessStudies of the same condition, open and under way.
- More trials run by The University of Hong KongThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Enrolment
- 450 participants
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- The Health Care and promotion Fund, the Governement of the Hong Kong SAR.
- Investigators
- Cindy L Lam, MD, Principal investigator, The University of Hong Kong
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00283270
- Sponsor's protocol ID
- RESCEP
- Other IDs
- HCPF 218016
- Status last verified
- Dec 2005
- First submitted
- 26 Jan 2006
- Last updated
- 27 Jan 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jan 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trial on the Effectiveness of Screening and Brief Counselling for Elderly Patients With Psychological Problems in Primary Care.
- ClinicalTrials.gov ID
- NCT00283270
- Acronym / sponsor ID
- RESCEP
- Conditions
- Mental Illness
- Keywords
- Mental health, Screening, Elderly, Chinese, Problem-solving counselling
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 450 participants
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- The Health Care and promotion Fund, the Governement of the Hong Kong SAR.
- Study start
- Nov 2002
- Study completion
- Aug 2005
- First posted
- 27 Jan 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Aged 60 or above
- Attending the study primary care clinic
- No known diagnosis of psychological problem
- Written consent provided
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Brief counselling | Behavioural | – |
| Behavior | Behavioural | – |
Primary outcome
Health-related quality of life scores
Hospital Anxiety and Depresssion scores
1 secondary outcome
Consultation rates
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jan 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Cindy L Lam, MD principal investigator
The University of Hong Kong
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Brief counselling and Behavior in people with Mental Illness, run by The University of Hong Kong.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Jan 2006. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Health-related quality of life scores. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jan 2006.