Depressive SymptomsNCT01786083
Caring for Family Caregivers:a Research-action Study
A study testing Application of Problem Solving Technique in people with Depressive Symptoms and Anxiety, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
Trial summary
The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically ill patients. Read more about this study
- Who is it for?
- Any age, women only
- Conditions the study is for
- Depressive Symptoms, Anxiety, Emotions
- What is being tested?
- Application of Problem Solving Technique
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 122 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2007to Jul 2011
- Phase
- Interventional
- 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 Any age
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Caregivers of chronically ill patients included in the ATDOM programme, who at the time of the intervention had a positive score on the Goldberg scale for anxiety and/or depression.
Who cannot join
- Professional caregivers
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Health Centers, Tarragona Province
Tarragona, Tarragona, 43000
About this study
Official title: Depression and Anxiety Symptoms Reduction and Perceived Wellbeing Improvement in Female Primary Caregivers of Chronically Ill Patients by the Application of Problem Solving Technique by Primary Health Care Nurses
The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically ill patients.
And also to describe and evaluate the process carried out by nurses when implementing the PST as a useful tool for care for family caregivers.
Read the detailed description
Background: In Spain, home care for the chronically ill and their family caregivers should be a priority in health and social policies due to the aging of the population and the progressive increase in dependent individuals. In our case, 88% of healthcare within dependency care is provided by the family and only 12% by health professionals. The family requires comprehensive and multidisciplinary ongoing care, in which the primary healthcare nurse plays a leading role. One of the areas involved is home-based nursing and counselling for family caregivers, in order to improve the quality of the care provided and to prevent issues arising that may adversely affect the caregiver's life.
Method: This is a research-action study with a mixed analysis methodology. Quantitative analysis was used to evaluate the effectiveness of the Problem Solving Technique in reducing symptoms of anxiety and depression among family caregivers. The clinical trial involved a control and experimental group and pre-post intervention measurements, using the Goldberg scale of anxiety and depression. The sample consisted of 122 caregivers who presented one of these positive subscales. The technique's application process was evaluated for the qualitative analysis, with a content analysis of the records of 10 nurses performing the experimental intervention.
- Conditions
- Depressive Symptoms, Anxiety, Emotions
- Being tested
- Application of Problem Solving Technique
- Keywords
- family caregivers, dependency, Problem Solving Technique, home based nursing
- Medical subject headings
- Depression, Anxiety Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Application of Problem Solving TechniqueBehavioural
| Study group | Role | What they receive |
|---|---|---|
| Lifestyle counseling | Experimental | Application of Problem Solving Technique Receives: Behavioral: Application of Problem Solving Technique |
| No counseling | No intervention | Usual care by caregiver |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anxiety
Goldberg Scale
Measured: Two years
Depression
Goldberg scale
Measured: Two years
perceived wellbeing levels
Primary caregiver's Emotional health(NOC 2506)
Measured: two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Feb 2013 (estimated)
- Study startSep 2007
- Primary completionSep 2009
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Depressive SymptomsStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Care provider
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina
- Sponsor type
- University, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01786083
- Sponsor's protocol ID
- 070489
- Status last verified
- Feb 2013
- First submitted
- 1 Feb 2013
- Last updated
- 8 Feb 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Feb 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Depression and Anxiety Symptoms Reduction and Perceived Wellbeing Improvement in Female Primary Caregivers of Chronically Ill Patients by the Application of Problem Solving Technique by Primary Health Care Nurses
- ClinicalTrials.gov ID
- NCT01786083
- Acronym / sponsor ID
- 070489
- Conditions
- Depressive Symptoms, Anxiety, Emotions
- Keywords
- family caregivers, dependency, Problem Solving Technique, home based nursing
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- Fundacio d'Investigacio en Atencio Primaria Jordi Gol i GurinaUniversity, hospital or other
- Collaborators
- Preventive Services and Health Promotion Research Network
- Study start
- Sep 2007
- Primary completion
- Sep 2009 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 7 Feb 2013 (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.
The purpose of this study is to evaluate the effectiveness of the Problem Solving Technique (PST) in reducing symptoms of anxiety and depression among primary caregivers of chronically ill patients.
And also to describe and evaluate the process carried out by nurses when implementing the PST as a useful tool for care for family caregivers.
Detailed description
Background: In Spain, home care for the chronically ill and their family caregivers should be a priority in health and social policies due to the aging of the population and the progressive increase in dependent individuals. In our case, 88% of healthcare within dependency care is provided by the family and only 12% by health professionals. The family requires comprehensive and multidisciplinary ongoing care, in which the primary healthcare nurse plays a leading role. One of the areas involved is home-based nursing and counselling for family caregivers, in order to improve the quality of the care provided and to prevent issues arising that may adversely affect the caregiver's life.
Method: This is a research-action study with a mixed analysis methodology. Quantitative analysis was used to evaluate the effectiveness of the Problem Solving Technique in reducing symptoms of anxiety and depression among family caregivers. The clinical trial involved a control and experimental group and pre-post intervention measurements, using the Goldberg scale of anxiety and depression. The sample consisted of 122 caregivers who presented one of these positive subscales. The technique's application process was evaluated for the qualitative analysis, with a content analysis of the records of 10 nurses performing the experimental intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lifestyle counseling | Experimental | Behavioral: Application of Problem Solving TechniqueApplication of Problem Solving Technique |
| No counseling | No intervention | –Usual care by caregiver |
Who may qualify
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers of chronically ill patients included in the ATDOM programme, who at the time of the intervention had a positive score on the Goldberg scale for anxiety and/or depression.
Key exclusion criteria (1 listed)
- Professional caregivers
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 |
|---|---|---|
| Application of Problem Solving Technique | Behavioural | Lifestyle counseling |
Primary outcome
Anxiety
Time frame: Two years
Goldberg Scale
Depression
Time frame: Two years
Goldberg scale
perceived wellbeing levels
Time frame: two years
Primary caregiver's Emotional health(NOC 2506)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Feb 2013.
- Social and Family Wellbeing Department of the Catalan GovernmentLink provided by the sponsor.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Application of Problem Solving Technique in people with Depressive Symptoms and Anxiety, run by Fundacio d'Investigacio en Atencio Primaria Jordi Gol i Gurina at 1 site in Spain.
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: finished, as of the sponsor's last update on 8 Feb 2013. 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 Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Anxiety (time frame: Two years). The study lists 3 primary outcomes in all. 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 8 Feb 2013.