Clinical trial NCT00430404: Screening and Treatment of Depression in the Community
Official title: Randomized Controlled Trial of a Community-based Early Psychiatric Intervention Strategy to Screen and Manage Depression in the Elderly
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Depression
Lead sponsor: National University Hospital, Singapore
Sponsor class: OTHER
Collaborators: name: National University of Singapore
First posted: 2007-02-01
Enrollment: 214
Sex: ALL
Minimum age (years): 60
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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:

1. increased rates of detection or recognition by a primary care physician of minor or major (clinical) depression.
2. 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
3. Reduced depressive symptom severity, improved level of daily functioning and quality of life among those with major clinical depression
4. Better patient satisfaction with care
5. 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.

Eligibility criteria: Inclusion Criteria:

* \> 60 years without dementia,
* Major depressive disorder,
* Bipolar disorder,
* Dysthymia disorder,
* Anxiety disorder,
* Mania/hypomania

Exclusion Criteria:

* 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,
* Current psychotic symptoms,
* Current alcohol abuse,
* Very high GDS score (\>=12) confirmed by SCID

Primary outcomes:
measure: Response to treatment at 6 months follow up is defined as a 50% reduction in HAMD-17 score
timeFrame: 6 months
Secondary outcomes:
measure: Rates of physician and patient self-report of service utilization at 6 month follow up
timeFrame: 6 months
measure: Improvement in follow-up SF-12 scores from baseline
timeFrame: 12 months
measure: Caregiver burden at 6 month follow-up
timeFrame: 6 months
measure: Patient satisfaction with care at 6 month follow up
timeFrame: 6 months
measure: Physician feedback at 6 month follow up
timeFrame: 6 months
Other outcomes:
Locations:
city: Singapore
country: Singapore
facility: Department of Psychological Medicine, National University Hospital, 5 Lower Kent Ridge Road
Study officials:
affiliation: Gerontological Research Programme, Faculty of Medicine, National University of Singapore
name: Ng Tz Pin, MD,MFPHM
role: PRINCIPAL_INVESTIGATOR
References: