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

Primary Purpose

Depression, Psychological Well-Being

Status

Unknown status

Phase

Phase 2

Locations

Finland

Study Type

Interventional

Intervention

Comprehensive psychosocial support for depressed elderly

About this trial

This is an interventional treatment trial for Depression focused on measuring Depression, Aging, Psychological well-being, Psychosocial intervention

Eligibility Criteria

60 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

age 60+

Exclusion Criteria:

severe memory disease

Sites / Locations

Central Union for the Welfare of the AgedRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Counseling

Arm Description

Outcomes

Primary Outcome Measures

Alleviating depressive symptoms measured with Geriatric Depression Scale

Secondary Outcome Measures

Quality of life measured with WHO QuolBref

Full Information

NCT ID

NCT00845377

First Posted

February 17, 2009

Last Updated

February 17, 2009

Sponsor

Central Union for the Welfare of the Aged

Collaborators

University of Eastern Finland

1. Study Identification

Unique Protocol Identification Number

NCT00845377

Brief Title

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

Official Title

Changing Minds - Studying the Effects of a Tailored Psychosocial Support Model on Depressive Mood and Quality of Life in Depressive Elderly People

Study Type

Interventional

2. Study Status

Record Verification Date

February 2009

Overall Recruitment Status

Unknown status

Study Start Date

April 2008 (undefined)

Primary Completion Date

April 2010 (Anticipated)

Study Completion Date

June 2010 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor

Central Union for the Welfare of the Aged

Collaborators

University of Eastern Finland

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

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

Depression, Psychological Well-Being

Keywords

Depression, Aging, Psychological well-being, Psychosocial intervention

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Counseling

Arm Type

Experimental

Intervention Type

Behavioral

Intervention Name(s)

Comprehensive psychosocial support for depressed elderly

Other Intervention Name(s)

Supporting elderly people with depression, Mental health counseling for elderly people, Individually tailored support model for old age depression

Intervention Description

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

Primary Outcome Measure Information:

Title

Alleviating depressive symptoms measured with Geriatric Depression Scale

Time Frame

base line, 6 months, 1 year

Secondary Outcome Measure Information:

Title

Quality of life measured with WHO QuolBref

Time Frame

base line, 6 months, 1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

60 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: age 60+ Exclusion Criteria: severe memory disease

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Marja K Saarenheimo, PhD

Phone

+358 50 367 6742

marja.saarenheimo@vtkl.fi

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Marja K Saarenheimo, PhD

Organizational Affiliation

Central Union for the Welfare of the Aged

Official's Role

Study Director

Facility Information:

Facility Name

Central Union for the Welfare of the Aged

City

Helsinki

ZIP/Postal Code

00700

Country

Finland

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Marja K Saarenheimo, PhD

12. IPD Sharing Statement

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

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