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Screening and Treatment of Depression in the Community

Primary Purpose

Depression

Status
Completed
Phase
Phase 4
Locations
Singapore
Study Type
Interventional
Intervention
Collaborative care (Intervention)
Sponsored by
National University Hospital, Singapore
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Depression

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Usual care (controlled group)

collaborative care (Intervention)

Arm Description

Usual care for management of depression

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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
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.
Caregiver burden at 6 month follow-up
Caregiver burden on taking care of depressive patients was assessed after 6months of study.
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.
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.

Full Information

First Posted
January 31, 2007
Last Updated
January 2, 2014
Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore
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1. Study Identification

Unique Protocol Identification Number
NCT00430404
Brief Title
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

2. Study Status

Record Verification Date
January 2014
Overall Recruitment Status
Completed
Study Start Date
August 2004 (undefined)
Primary Completion Date
August 2007 (Actual)
Study Completion Date
September 2007 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
National University Hospital, Singapore
Collaborators
National University of Singapore

4. Oversight

Data Monitoring Committee
No

5. Study Description

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: 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Depression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
214 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Usual care (controlled group)
Arm Type
No Intervention
Arm Description
Usual care for management of depression
Arm Title
collaborative care (Intervention)
Arm Type
Experimental
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Collaborative care (Intervention)
Other Intervention Name(s)
Community based early psychiatric intervention strategy
Intervention Description
Structured shared care with treatment protocol & support
Primary Outcome Measure Information:
Title
Response to treatment at 6 months follow up is defined as a 50% reduction in HAMD-17 score
Description
After enrolled in the study for 6 months, depressive symptoms were expected to reduce to 50% in assessment fo HAM_D 17
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Rates of physician and patient self-report of service utilization at 6 month follow up
Description
Report of primary care physicians and patient's self report of using of health service for the treatment of depression
Time Frame
6 months
Title
Improvement in follow-up SF-12 scores from baseline
Description
Study participants' physical component and mental component of Quality of life were assessed after 12 months.
Time Frame
12 months
Title
Caregiver burden at 6 month follow-up
Description
Caregiver burden on taking care of depressive patients was assessed after 6months of study.
Time Frame
6 months
Title
Patient satisfaction with care at 6 month follow up
Description
Participants under intervention care (collaborative care) were surveyed about their satisfaction with the program after 6 months of enrollment in the study.
Time Frame
6 months
Title
Physician feedback at 6 month follow up
Description
primary physicians in the both arms were surveyed for their satisfaction about the study programme after the 6 months of study.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ng Tz Pin, MD,MFPHM
Organizational Affiliation
Gerontological Research Programme, Faculty of Medicine, National University of Singapore
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Psychological Medicine, National University Hospital, 5 Lower Kent Ridge Road
City
Singapore
ZIP/Postal Code
119074
Country
Singapore

12. IPD Sharing Statement

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Screening and Treatment of Depression in the Community

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