NCT00430404

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
214

participants targeted

Target at P75+ for phase_4 depression

Timeline
Completed

Started Aug 2004

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2004

Completed
2.5 years until next milestone

First Submitted

Initial submission to the registry

January 31, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 1, 2007

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2007

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2007

Completed
Last Updated

January 3, 2014

Status Verified

January 1, 2014

Enrollment Period

3 years

First QC Date

January 31, 2007

Last Update Submit

January 2, 2014

Conditions

Outcome Measures

Primary Outcomes (1)

  • 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

    6 months

Secondary Outcomes (5)

  • Rates of physician and patient self-report of service utilization at 6 month follow up

    6 months

  • Improvement in follow-up SF-12 scores from baseline

    12 months

  • Caregiver burden at 6 month follow-up

    6 months

  • Patient satisfaction with care at 6 month follow up

    6 months

  • Physician feedback at 6 month follow up

    6 months

Study Arms (2)

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.

Other: Collaborative care (Intervention)

Interventions

Structured shared care with treatment protocol \& support

Also known as: Community based early psychiatric intervention strategy
collaborative care (Intervention)

Eligibility Criteria

Age60 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Psychological Medicine, National University Hospital, 5 Lower Kent Ridge Road

Singapore, 119074, Singapore

Location

MeSH Terms

Conditions

Depression

Interventions

Methods

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehavior

Intervention Hierarchy (Ancestors)

Investigative Techniques

Study Officials

  • Ng Tz Pin, MD,MFPHM

    Gerontological Research Programme, Faculty of Medicine, National University of Singapore

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Ng Tz Pin, MD, MFPHM, National University Hospital, Singapore

Study Record Dates

First Submitted

January 31, 2007

First Posted

February 1, 2007

Study Start

August 1, 2004

Primary Completion

August 1, 2007

Study Completion

September 1, 2007

Last Updated

January 3, 2014

Record last verified: 2014-01

Locations