Undiagnosed Psychological ProblemsNCT00863031
A Trial on the Effectiveness of Screening and Brief Problem-Solving Therapy (PST) for Elderly Patients With Psychological Problems
A study testing problem-solving therapy and Video-viewing in people with Undiagnosed Psychological Problems, run by The University of Hong Kong at 1 site in Hong Kong.
Trial summary
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: 1. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Undiagnosed Psychological Problems
- What is being tested?
- problem-solving therapy and Video-viewing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 299 participants
- Where
- 1 siteHong Kong
- Study dates
- Nov 2002to Jun 2006
- Phase
- Interventional
- 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
- not known to have any psychological problem
- HADS Depression score 6 or above, or Anxiety Score 3 or above
- Written consent to study
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Undiagnosed Psychological Problems
- Being tested
- problem-solving therapy, Video-viewing
- Keywords
- mental health, problem-solving therapy, elderly, health-related quality of life, primary care, Chinese
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
problem-solving therapyBehavioural
Three sessions of problem-solving therapy at week 1, 3 and 5.
Video-viewingBehavioural
Three sessions of viewing health educational videos.
| Study group | Role | What they receive |
|---|---|---|
| problem-solving therapy | Experimental | Three sessions of brief problem-solving counselling at week 1, 3 and 5 by a family doctor. Receives: Behavioral: problem-solving therapy |
| viewing video | Placebo comparator | Three sessions of health education viewing video in groups of 3 to 5 people Receives: Behavioral: Video-viewing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Health-related quality of life scores
Measured: 6, 12, 26 and 52 weeks
Secondary outcomes (1)
Hospital Anxiety & Depression Scale scores
Measured: 6, 12, 26 and 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Mar 2009 (estimated)
- Study startNov 2002
- Primary completionDec 2005
- Study completionJun 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Undiagnosed Psychological ProblemsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 299 participants (actual)
Sponsor and investigators
- Lead sponsor
- The University of Hong Kong
- Sponsor type
- University, hospital or other
- Collaborators
- Health Care and Promotion Fund, Government of the Hong Kong SAR
- Investigators
- Cindy L.K. Lam, MD, Principal investigator, Family Medicine Unit, Faculty of Medicine, HKU
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00863031
- Sponsor's protocol ID
- HKCTR-497
- Status last verified
- Mar 2009
- First submitted
- 15 Mar 2009
- Last updated
- 17 Mar 2009
- Results posted
- No
- Data monitoring committee
- No
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 at a glance
From the registry record, last updated by the sponsor on 17 Mar 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomised Controlled Trail on the Effectiveness of Screening and Brief Counselling (Problem-Solving Therapy) for Elderly Patients With Psychological Problems in Primary Care.
- ClinicalTrials.gov ID
- NCT00863031
- Acronym / sponsor ID
- HKCTR-497
- Conditions
- Undiagnosed Psychological Problems
- Keywords
- mental health, problem-solving therapy, elderly, health-related quality of life, primary care, Chinese
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 299 participants (actual)
- Lead sponsor
- The University of Hong KongUniversity, hospital or other
- Collaborators
- Health Care and Promotion Fund, Government of the Hong Kong SAR
- Study start
- Nov 2002
- Primary completion
- Dec 2005 (actual)
- Study completion
- Jun 2006 (actual)
- First posted
- 17 Mar 2009 (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 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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| problem-solving therapy | Experimental | Behavioral: problem-solving therapyThree sessions of brief problem-solving counselling at week 1, 3 and 5 by a family doctor. |
| viewing video | Placebo comparator | Behavioral: Video-viewingThree sessions of health education viewing video in groups of 3 to 5 people |
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
- not known to have any psychological problem
- HADS Depression score 6 or above, or Anxiety Score 3 or above
- Written consent to study
Key exclusion criteria (6 listed)
- 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
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 |
|---|---|---|
| problem-solving therapyThree sessions of problem-solving therapy at week 1, 3 and 5. | Behavioural | problem-solving therapy |
| Video-viewingThree sessions of viewing health educational videos. | Behavioural | viewing video |
Primary outcome
Health-related quality of life scores
Time frame: 6, 12, 26 and 52 weeks
1 secondary outcome
Hospital Anxiety & Depression Scale scores
Time frame: 6, 12, 26 and 52 weeks
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 17 Mar 2009.
- Results publicationLam 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.
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.K. Lam, MD principal investigator
Family Medicine Unit, Faculty of Medicine, HKU
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing problem-solving therapy and Video-viewing in people with Undiagnosed Psychological Problems, run by The University of Hong Kong at 1 site in 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 6 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 17 Mar 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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 (time frame: 6, 12, 26 and 52 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00863031, which also lists 1 linked publication.
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 17 Mar 2009.