DepressionPhase 4NCT00430404
Screening and Treatment of Depression in the Community
A Phase 4 study testing Collaborative care (Intervention) in people with Depression, run by National University Hospital, Singapore at 1 site in Singapore.
Trial summary
To evaluate the effectiveness of a community-based strategy of routine population mass screening for depression with follow-up feedback and management in a primary care non-psychiatric setting involving a structured, multifaceted, collaborative (primary care and hospital-based)shared care programme. Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Depression
- What is being tested?
- Collaborative care (Intervention)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 214 participants
- Where
- 1 siteSingapore
- Study dates
- Aug 2004to Sep 2007
- 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
- > 60 years without dementia,
- Major depressive disorder,
- Bipolar disorder,
- Dysthymia disorder,
- Anxiety disorder,
- Mania/hypomania
Who cannot join
- Severe post-stroke dementia or aphasia,
- History of mania, psychiatric consultation or admission to hospital in past 3 months,
- MMSE score <18,
- Fully dependent at 3 or more basic activities of daily living,
- Very high BDI score (>=30),
- Serious suicidal risk,
Show all 9Show fewer
- Current psychotic symptoms,
- Current alcohol abuse,
- Very high GDS score (>=12) confirmed by SCID
Trial locations and contacts
1 site in 1 country.
Singapore1 site
Department of Psychological Medicine, National University Hospital, 5 Lower Kent Ridge Road
Singapore, 119074
About this study
Official title: Randomized Controlled Trial of a Community-based Early Psychiatric Intervention Strategy to Screen and Manage Depression in the Elderly
To evaluate the effectiveness of a community-based strategy of routine population mass screening for depression with follow-up feedback and management in a primary care non-psychiatric setting involving a structured, multifaceted, collaborative (primary care and hospital-based)shared care programme.
Hypotheses:
Read more
We hypothesize that a community-based early psychiatric interventional strategy (CEPIS) for depression in the elderly leads to increased recognition of depression by primary care physicians, more initiation of treatment for emotional problems, and improved outcomes for patients with depression, as measured by:
- increased rates of detection or recognition by a primary care physician of minor or major (clinical) depression.
- higher rates of management activities: counselling for psychological, family social problems, contact with community family services (human service agency), consultation and/or referral to a mental health specialist
- Reduced depressive symptom severity, improved level of daily functioning and quality of life among those with major clinical depression
- Better patient satisfaction with care
- Favourable clinician's and patients perception of their usefulness or acceptability
Read the detailed description
Depression is a highly prevalent, clinically under-recognized and under-treated medical disorder world wide. In Singapore, 17% of the adult population experience recent psychiatric disturbances, yet only 6% use the services of any health professional. General practitioners are the most commonly preferred caregiver, and actually used by 41.1% of those who sought help. At the same time, suicide rates especially among the elderly remain at very high levels compared to other countries in the world.
In recent decades, screening questionnaires have been developed and validated that are suitable for the initial detection of depression in the primary care setting. Previous research have shown that screening for depression do not result in increased recognition rates of mental disorders unless positive cases are selectively fed back to primary care physicians. They also do not translate into increased rates of interventional activities such as initiation of therapy and referral to mental health specialists. Neither dose primary care physician education or clinical practice guidelines result in any improved outcomes for the patients unless these are accompanied by more sophisticated strategies in the organization and delivery of care, such as structured, collaborative, multidisciplinary care together with quality improvement processes.
More empirical data are therefore needed to establish whether screening for psychiatric disorders will enhance the recognition of clinical disorder, leading to better patient outcomes.
- Conditions
- Depression
- Being tested
- Collaborative care (Intervention)
- Medical subject headings
- Depression
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Collaborative care (Intervention)Other
Also called Community based early psychiatric intervention strategy
Structured shared care with treatment protocol \& support
| Study group | Role | What they receive |
|---|---|---|
| Usual care (controlled group) | No intervention | Usual care for management of depression |
| collaborative care (Intervention) | Experimental | Collaborative care for management of depression for intervention group. We provided multidisciplinary groups of care from psychiatrist, psychologist, social counselor, general practitioners and case managers for intervention group. Receives: Other: Collaborative care (Intervention) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Response to treatment at 6 months follow up is defined as a 50% reduction in HAMD-17 score
After enrolled in the study for 6 months, depressive symptoms were expected to reduce to 50% in assessment fo HAM_D 17
Measured: 6 months
Secondary outcomes (5)
Rates of physician and patient self-report of service utilization at 6 month follow up
Report of primary care physicians and patient's self report of using of health service for the treatment of depression
Measured: 6 months
Improvement in follow-up SF-12 scores from baseline
Study participants' physical component and mental component of Quality of life were assessed after 12 months.
Measured: 12 months
Caregiver burden at 6 month follow-up
Caregiver burden on taking care of depressive patients was assessed after 6months of study.
Measured: 6 months
Patient satisfaction with care at 6 month follow up
Participants under intervention care (collaborative care) were surveyed about their satisfaction with the program after 6 months of enrollment in the study.
Measured: 6 months
Physician feedback at 6 month follow up
primary physicians in the both arms were surveyed for their satisfaction about the study programme after the 6 months of study.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2007 (estimated)
- Study startAug 2004
- Primary completionAug 2007
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- More trials run by National University Hospital, SingaporeThe 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
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 214 participants (actual)
Sponsor and investigators
- Lead sponsor
- National University Hospital, Singapore
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Singapore
- Responsible party
- Principal investigator, Psychological Medicine, National University Hospital, Singapore
- Investigators
- Ng Tz Pin, MD,MFPHM, Principal investigator, Gerontological Research Programme, Faculty of Medicine, National University of Singapore
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00430404
- Sponsor's protocol ID
- NMRC/0846/2004
- Status last verified
- Jan 2014
- First submitted
- 31 Jan 2007
- Last updated
- 3 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of a Community-based Early Psychiatric Intervention Strategy to Screen and Manage Depression in the Elderly
- ClinicalTrials.gov ID
- NCT00430404
- Acronym / sponsor ID
- NMRC/0846/2004
- Conditions
- Depression
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 214 participants (actual)
- Lead sponsor
- National University Hospital, SingaporeUniversity, hospital or other
- Collaborators
- National University of Singapore
- Study start
- Aug 2004
- Primary completion
- Aug 2007 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 1 Feb 2007 (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.
To evaluate the effectiveness of a community-based strategy of routine population mass screening for depression with follow-up feedback and management in a primary care non-psychiatric setting involving a structured, multifaceted, collaborative (primary care and hospital-based)shared care programme.
Hypotheses:
We hypothesize that a community-based early psychiatric interventional strategy (CEPIS) for depression in the elderly leads to increased recognition of depression by primary care physicians, more initiation of treatment for emotional problems, and improved outcomes for patients with depression, as measured by:
- increased rates of detection or recognition by a primary care physician of minor or major (clinical) depression.
- higher rates of management activities: counselling for psychological, family social problems, contact with community family services (human service agency), consultation and/or referral to a mental health specialist
- Reduced depressive symptom severity, improved level of daily functioning and quality of life among those with major clinical depression
- Better patient satisfaction with care
- Favourable clinician's and patients perception of their usefulness or acceptability
Detailed description
Depression is a highly prevalent, clinically under-recognized and under-treated medical disorder world wide. In Singapore, 17% of the adult population experience recent psychiatric disturbances, yet only 6% use the services of any health professional. General practitioners are the most commonly preferred caregiver, and actually used by 41.1% of those who sought help. At the same time, suicide rates especially among the elderly remain at very high levels compared to other countries in the world.
In recent decades, screening questionnaires have been developed and validated that are suitable for the initial detection of depression in the primary care setting. Previous research have shown that screening for depression do not result in increased recognition rates of mental disorders unless positive cases are selectively fed back to primary care physicians. They also do not translate into increased rates of interventional activities such as initiation of therapy and referral to mental health specialists. Neither dose primary care physician education or clinical practice guidelines result in any improved outcomes for the patients unless these are accompanied by more sophisticated strategies in the organization and delivery of care, such as structured, collaborative, multidisciplinary care together with quality improvement processes.
More empirical data are therefore needed to establish whether screening for psychiatric disorders will enhance the recognition of clinical disorder, leading to better patient outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Usual care (controlled group) | No intervention | –Usual care for management of depression |
| collaborative care (Intervention) | Experimental | Other: Collaborative care (Intervention)Collaborative care for management of depression for intervention group. We provided multidisciplinary groups of care from psychiatrist, psychologist, social counselor, general practitioners and case managers for intervention group. |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- > 60 years without dementia,
- Major depressive disorder,
- Bipolar disorder,
- Dysthymia disorder,
- Anxiety disorder,
Key exclusion criteria (9 listed)
- Severe post-stroke dementia or aphasia,
- History of mania, psychiatric consultation or admission to hospital in past 3 months,
- MMSE score <18,
- Fully dependent at 3 or more basic activities of daily living,
- Very high BDI score (>=30),
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 |
|---|---|---|
| Collaborative care (Intervention)Also: Community based early psychiatric intervention strategyStructured shared care with treatment protocol \& support | Other | collaborative care (Intervention) |
Primary outcome
Response to treatment at 6 months follow up is defined as a 50% reduction in HAMD-17 score
Time frame: 6 months
After enrolled in the study for 6 months, depressive symptoms were expected to reduce to 50% in assessment fo HAM_D 17
5 secondary outcomes
Rates of physician and patient self-report of service utilization at 6 month follow up
Time frame: 6 months
Improvement in follow-up SF-12 scores from baseline
Time frame: 12 months
Caregiver burden at 6 month follow-up
Time frame: 6 months
Patient satisfaction with care at 6 month follow up
Time frame: 6 months
Physician feedback at 6 month follow up
Time frame: 6 months
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 3 Jan 2014.
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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.
Ng Tz Pin, MD,MFPHM principal investigator
Gerontological Research Programme, Faculty of Medicine, National University of Singapore
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Collaborative care (Intervention) in people with Depression, run by National University Hospital, Singapore at 1 site in Singapore.
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 6 inclusion and 9 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 3 Jan 2014. 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 Singapore. 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. 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?
Response to treatment at 6 months follow up is defined as a 50% reduction in HAMD-17 score (time frame: 6 months). 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 3 Jan 2014.