DepressionPhase 2NCT00845377
Changing Minds - Supporting Depressed Elderly People With an Individually Tailored Service Model
A Phase 2 study testing Comprehensive psychosocial support for depressed elderly in people with Depression and Psychological Well-Being, run by Central Union for the Welfare of the Aged at 1 site in Finland.
Trial 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… Read more about this study
- Who is it for?
- Ages 60 years and olderHealthy volunteers can take part
- Conditions the study is for
- Depression, Psychological Well-Being
- What is being tested?
- Comprehensive psychosocial support for depressed elderly
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 1 siteFinland
- Study dates
- Apr 2008to Jun 2010
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- age 60+
Who cannot join
- severe memory disease
Trial locations and contacts
1 site in 1 country.
Finland1 site, 1 recruiting
- Recruiting
Central Union for the Welfare of the Aged
Helsinki, 00700
Marja K Saarenheimo, PhD
About this study
Official title: Changing Minds - Studying the Effects of a Tailored Psychosocial Support Model on Depressive Mood and Quality of Life in Depressive Elderly People
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.
- Conditions
- Depression, Psychological Well-Being
- Being tested
- Comprehensive psychosocial support for depressed elderly
- Keywords
- Depression, Aging, Psychological well-being, Psychosocial intervention
- Medical subject headings
- Depression, Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Comprehensive psychosocial support for depressed elderlyBehavioural
Also called Supporting elderly people with depression, Mental health counseling for elderly people, Individually tailored support model for old age depression
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
| Study group | Role | What they receive |
|---|---|---|
| Counseling | Experimental | Not described Receives: Behavioral: Comprehensive psychosocial support for depressed elderly |
What is being measured
The primary outcome is the main question the study is designed to answer.
Alleviating depressive symptoms measured with Geriatric Depression Scale
Measured: base line, 6 months, 1 year
Secondary outcomes (1)
Quality of life measured with WHO QuolBref
Measured: base line, 6 months, 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2009 (estimated)
- Study startApr 2008
- Primary completionApr 2010 (estimated)
- Study completionJun 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for DepressionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Union for the Welfare of the Aged
- Sponsor type
- University, hospital or other
- Collaborators
- University of Eastern Finland
- Investigators
- Marja K Saarenheimo, PhD, Study director, Central Union for the Welfare of the Aged
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00845377
- Sponsor's protocol ID
- CUWAged 0901
- Status last verified
- Feb 2009
- First submitted
- 17 Feb 2009
- Last updated
- 18 Feb 2009
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Feb 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Changing Minds - Studying the Effects of a Tailored Psychosocial Support Model on Depressive Mood and Quality of Life in Depressive Elderly People
- ClinicalTrials.gov ID
- NCT00845377
- Acronym / sponsor ID
- CUWAged 0901
- Conditions
- Depression, Psychological Well-Being
- Keywords
- Depression, Aging, Psychological well-being, Psychosocial intervention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Central Union for the Welfare of the AgedUniversity, hospital or other
- Collaborators
- University of Eastern Finland
- Study start
- Apr 2008
- Primary completion
- Apr 2010 (estimated)
- Study completion
- Jun 2010 (estimated)
- First posted
- 18 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Counseling | Experimental | Behavioral: Comprehensive psychosocial support for depressed elderly |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- age 60+
Key exclusion criteria (1 listed)
- severe memory disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Comprehensive psychosocial support for depressed elderlyAlso: Supporting elderly people with depression, Mental health counseling for elderly people, Individually tailored support model for old age depressionThe 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 | Behavioural | Counseling |
Primary outcome
Alleviating depressive symptoms measured with Geriatric Depression Scale
Time frame: base line, 6 months, 1 year
1 secondary outcome
Quality of life measured with WHO QuolBref
Time frame: base line, 6 months, 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Feb 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Marja K Saarenheimo, PhD study director
Central Union for the Welfare of the Aged
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Comprehensive psychosocial support for depressed elderly in people with Depression and Psychological Well-Being, run by Central Union for the Welfare of the Aged at 1 site in Finland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 18 Feb 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Finland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marja K Saarenheimo, PhD (+358 50 367 6742, marja.saarenheimo@vtkl.fi), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Alleviating depressive symptoms measured with Geriatric Depression Scale (time frame: base line, 6 months, 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Feb 2009.