Screening and Treatment of Depression in the Community

This study has been completed.
Sponsor:
Collaborator:
National University, Singapore
Information provided by (Responsible Party):
Psychological Medicine, National University Hospital, Singapore
ClinicalTrials.gov Identifier:
NCT00430404
First received: January 31, 2007
Last updated: January 2, 2014
Last verified: January 2014
  Purpose

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

Condition Intervention Phase
Depression
Other: Collaborative care (Intervention)
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Controlled Trial of a Community-based Early Psychiatric Intervention Strategy to Screen and Manage Depression in the Elderly

Resource links provided by NLM:


Further study details as provided by National University Hospital, Singapore:

Primary Outcome Measures:
  • Response to treatment at 6 months follow up is defined as a 50% reduction in HAMD-17 score [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 12 months ] [ Designated as safety issue: No ]
    Study participants' physical component and mental component of Quality of life were assessed after 12 months.

  • Caregiver burden at 6 month follow-up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    Caregiver burden on taking care of depressive patients was assessed after 6months of study.

  • Patient satisfaction with care at 6 month follow up [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    primary physicians in the both arms were surveyed for their satisfaction about the study programme after the 6 months of study.


Enrollment: 214
Study Start Date: August 2004
Study Completion Date: September 2007
Primary Completion Date: August 2007 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
No Intervention: Usual care (controlled group)
Usual care for management of depression
Experimental: 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.
Other: Collaborative care (Intervention)
Structured shared care with treatment protocol & support
Other Name: Community based early psychiatric intervention strategy

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

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00430404

Locations
Singapore
Department of Psychological Medicine, National University Hospital, 5 Lower Kent Ridge Road
Singapore, Singapore, 119074
Sponsors and Collaborators
National University Hospital, Singapore
National University, Singapore
Investigators
Principal Investigator: Ng Tz Pin, MD,MFPHM Gerontological Research Programme, Faculty of Medicine, National University of Singapore
  More Information

No publications provided

Responsible Party: Psychological Medicine, Ng Tz Pin, MD, MFPHM, National University Hospital, Singapore, National University Hospital, Singapore
ClinicalTrials.gov Identifier: NCT00430404     History of Changes
Other Study ID Numbers: NMRC/0846/2004
Study First Received: January 31, 2007
Last Updated: January 2, 2014
Health Authority: Singapore: Domain Specific Review Boards

Additional relevant MeSH terms:
Depression
Depressive Disorder
Behavioral Symptoms
Mood Disorders
Mental Disorders

ClinicalTrials.gov processed this record on August 26, 2014