Changing Minds - Supporting Depressed Elderly People With... | NCT00845377

Studies
Changing Minds - Supporting Depressed Elderly People With an Individually Tailored Service Model

NCT00845377

Sponsor

Central Union for the Welfare of the Aged

Status

Unknown status

Last Update Posted

Feb 18, 2009Estimated

Enrollment

200Estimated

Phase

Phase 2

Conditions

Depression
Psychological Well-Being

Interventions

Comprehensive psychosocial support for depressed elderly

Countries

Finland

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2009

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2008

Primary Completion Date

Apr 2010Estimated

Completion Date

Jun 2010Estimated

First Submitted Date

Feb 17, 2009

First Submission Date that Met QC Criteria

Feb 17, 2009

First Posted Date

Feb 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 17, 2009

Last Update Posted Date

Feb 18, 2009Estimated

Name	Class
University of Eastern Finland	OTHER

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Depression is one of the leading causes of emotional suffering in later life. It has been estimated that 2-5% of community-dwelling elderly people suffer from major depression, but according to recent studies, as much as 25 % have clinically significant depressive symptoms.Typically, depressive symptoms in the elderly are treated solely with antidepressants.

The aim of this project is to study the effects of a comprehensive psychosocial intervention on the psychological well-being, quality of life and use of services in depressed elderly people. In addition, the processes of intervention are studied from the perspective of the participants as well as the service system. The research is conducted in collaboration with the city of Espoo. The design of the study combines clinical trial with qualitative process analysis.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

200Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Counseling	Experimental		Behavioral: Comprehensive psychosocial support for depressed elderly

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Comprehensive psychosocial support for depressed elderly	Behavioral	The model includes a psychiatric nurse as a care manager, a multiprofessional team with a physiotherapist, psychologist and psychiatrist. Each participant receives individually tailored services such as therapeutic groups, conversation groups, physical exercise, music therapy, art therapy and nutritional counseling

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Alleviating depressive symptoms measured with Geriatric Depression Scale		base line, 6 months, 1 year

Secondary Outcomes

Measure	Description	Time Frame
Quality of life measured with WHO QuolBref		base line, 6 months, 1 year

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

age 60+

Exclusion Criteria:

severe memory disease

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

60 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marja K Saarenheimo, PhD	Contact	+358 50 367 6742		marja.saarenheimo@vtkl.fi

Overall Officials

Name	Affiliation	Role
Marja K Saarenheimo, PhD	Central Union for the Welfare of the Aged	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Central Union for the Welfare of the Aged	Recruiting	Helsinki		00700	Finland

Condition Browse Module

MeSH Terms

ID	Term
D003863	Depression
D000092862	Psychological Well-Being

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D010549	Personal Satisfaction

Browse Leaves

Not provided

Browse Branches

Not provided