Mental HealthIGFCNCT01177696
Intervention in Groups of Family Caregivers in Primary Health Care
A study testing Psychotherapeutic intervention in people with Mental Health, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud at 1 site in Spain.
Trial summary
Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mental Health
- What is being tested?
- Psychotherapeutic intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteSpain
- Study dates
- Sep 2008to Sep 2010
- 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers
Who cannot join
- Those persons who did not share their place of residence with the relative, or who were impossible to locate either due to a change of address or being admitted to hospital or a nursing home, or on account of the patient's death were excluded
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary care Research unit. La Alamedilla health centre
Salamanca, Salamanca., 37003
About this study
Official title: VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.
Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers.
The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.
To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly face the care.
Read the detailed description
Methods/Design: Design: This is multicentre cross-sectional study, randomized in two parallel groups.
Setting: Two different urban PHC. Study population: 150 caregivers will be included by consecutive sampling. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Of chance form 100 caregivers will be assigned to the experimental group and 50 to the group control.
Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz \& Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed.
Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
Discussion: Psychotherapeutic interventions have been proved to obtain better results to reduce symptomatology and improve emotional state of caregivers. Moreover, this intervention has been proved to be effective in a different setting other than PHC, and was developed by professionals of Mental Health. If we found that this intervention is effective in PHC and with our professionals, it would be an important instrument to offer to caregivers of care-dependent patients.
- Conditions
- Mental Health
- Being tested
- Psychotherapeutic intervention
- Keywords
- caregivers, Family Health, Psychotherapeutic, Primary Health Care
- Medical subject headings
- Psychological Well-Being
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Psychotherapeutic interventionBehavioural
Also called Received usual care.
A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
| Study group | Role | What they receive |
|---|---|---|
| psychotherapy | Experimental | The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health of caregivers.
This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres. Receives: Behavioral: Psychotherapeutic intervention |
| Control | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in caregivers will be the principal measure:
family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz \& Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring.
Measured: Initial and 6 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Aug 2010 (estimated)
- Study startSep 2008
- Primary completionJun 2009 (estimated)
- Study completionSep 2010 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Mental HealthStudies 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
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la Salud
- Sponsor type
- University, hospital or other
- Investigators
- Rodriguez-Sanchez Emiliano, MD, Principal investigator, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.Mora-Simón Sara, Study chair, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.Porras-Santos Nieves, Study chair, La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.Patino-Alonso M. Carmen, MD, Study chair, Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain.Recio-Rodríguez José-Ignacio, Study chair, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, SpainBecerro-Muñoz Concepción, MD, Study chair, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, SpainPérez-Arachaederra Diana, Study chair, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, SpainGómez-Marcos Manuel-Ángel, md, Study chair, La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01177696
- Sponsor's protocol ID
- GRS270A08
- Acronym
- IGFC
- Status last verified
- Aug 2010
- First submitted
- 30 Jul 2010
- Last updated
- 9 Aug 2010
- Results posted
- No
- Data monitoring committee
- No
Publications
Rodriguez-Sanchez E, Mora-Simon S, Porras-Santos N, Patino-Alonso MC, Recio-Rodriguez JI, Becerro-Munoz C, Perez-Arechaederra D, Gomez-Marcos MA, Garcia-Ortiz L. Effectiveness of an intervention in groups of family caregivers of dependent patients for their application in primary health centers. Study protocol. BMC Public Health. 2010 Sep 17;10:559. doi: 10.1186/1471-2458-10-559.
PubMed 20849630
Study at a glance
From the registry record, last updated by the sponsor on 9 Aug 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE.
- ClinicalTrials.gov ID
- NCT01177696
- Acronym / sponsor ID
- IGFC / GRS270A08
- Conditions
- Mental Health
- Keywords
- caregivers, Family Health, Psychotherapeutic, Primary Health Care
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Fundacion para la Investigacion y Formacion en Ciencias de la SaludUniversity, hospital or other
- Study start
- Sep 2008
- Primary completion
- Jun 2009 (estimated)
- Study completion
- Sep 2010 (estimated)
- First posted
- 9 Aug 2010 (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.
Although Primary Health Care (PHC) Teams are used to deal with prevention and treatment of sanitary problems in adults with chronic diseases, they usually have a lack of experience in development of psychotherapeutic interventions. However, these interventions are the ones that achieve better results to reduce symptomatology and improve emotional state of caregivers.
The study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health and quality of life of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres.
To assess a cognitive-behavioural intervention to modify dysfunctional thoughts to properly face the care.
Detailed description
Methods/Design: Design: This is multicentre cross-sectional study, randomized in two parallel groups.
Setting: Two different urban PHC. Study population: 150 caregivers will be included by consecutive sampling. They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers. Of chance form 100 caregivers will be assigned to the experimental group and 50 to the group control.
Measurements: Each caregiver will be evaluated on a personal interview. The caregivers' assessment protocol: 1) Assessment of different socio-demographic related to care, and caregiver's personal situation. 2)Care-dependent individuals will also be assessed by Barthel Index and Pfeiffer Questionnaire (SPMSQ). 3)Change in caregivers will be the principal measure: family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz \& Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring. 4) Intervention implementation measures will also be assessed.
Intervention: A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia.
Discussion: Psychotherapeutic interventions have been proved to obtain better results to reduce symptomatology and improve emotional state of caregivers. Moreover, this intervention has been proved to be effective in a different setting other than PHC, and was developed by professionals of Mental Health. If we found that this intervention is effective in PHC and with our professionals, it would be an important instrument to offer to caregivers of care-dependent patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| psychotherapy | Experimental | Behavioral: Psychotherapeutic interventionThe study aims to evaluate the effectiveness of an intervention of psychotherapy in improving the mental health of caregivers. This intervention is based on theoretical approaches to care adjusted to cognitive theory, in order to be applied in primary health care centres. |
| Control | No intervention | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers
Key exclusion criteria (1 listed)
- Those persons who did not share their place of residence with the relative, or who were impossible to locate either due to a change of address or being admitted to hospital or a nursing home, or on account of the patient's death were excluded
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 |
|---|---|---|
| Psychotherapeutic interventionAlso: Received usual care.A psychotherapeutic intervention will be 8 sessions of 90 minutes in a pilot study groups. This intervention has been initially developed for family caregivers of patients with dementia. | Behavioural | psychotherapy |
Primary outcome
Change in caregivers will be the principal measure:
Time frame: Initial and 6 months later
family function (Family APGAR Questionnaire), burden short questionnaire (Short Zarit Burden Interview), quality of life (Ruiz \& Baca: 1993 Questionnaire), the Duke-UNK Functional Social Support Questionnaire, the General Health Questionnaire-12, and changes in Dysfunctional Thoughts about caring.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Aug 2010.
- Derived from this study: PubMed 20849630Rodriguez-Sanchez E, Mora-Simon S, Porras-Santos N, Patino-Alonso MC, Recio-Rodriguez JI, Becerro-Munoz C, Perez-Arechaederra D, Gomez-Marcos MA, Garcia-Ortiz L. Effectiveness of an intervention in groups of family caregivers of dependent patients for their application in primary health centers. Study protocol. BMC Public Health. 2010 Sep 17;10:559. doi: 10.1186/1471-2458-10-559.
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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.
Rodriguez-Sanchez Emiliano, MD principal investigator
La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
Mora-Simón Sara study chair
La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.
Porras-Santos Nieves study chair
La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Psychotherapeutic intervention in people with Mental Health, run by Fundacion para la Investigacion y Formacion en Ciencias de la Salud 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: status not confirmed, as of the sponsor's last update on 9 Aug 2010. 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?
Results are not available in the source record.
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?
Change in caregivers will be the principal measure: (time frame: Initial and 6 months later). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01177696, which also lists 1 linked publication.
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 9 Aug 2010.