Intervention in Groups of Family Caregivers in Primary Health Care (IGFC)
Recruitment status was Active, not recruiting
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Mental Health |
Behavioral: Psychotherapeutic intervention |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| Official Title: | VALIDATION OF AN INTERVENTION EFFECTIVE IN GROUPS OF FAMILY CAREGIVERS OF DEPENDENT PATIENTS FOR THEIR APPLICATION IN CENTRES OF PRIMARY HEALTH CARE. |
- Change in caregivers will be the principal measure: [ Time Frame: Initial and 6 months later ] [ Designated as safety issue: No ]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.
| Estimated Enrollment: | 150 |
| Study Start Date: | September 2008 |
| Estimated Study Completion Date: | September 2010 |
| Estimated Primary Completion Date: | June 2009 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: psychotherapy
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. |
Behavioral: Psychotherapeutic 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.
Other Name: Received usual care.
|
| No Intervention: Control |
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.
Eligibility| Ages Eligible for Study: | 18 Years and older |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers
Exclusion Criteria:
- 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
Contacts and Locations| Spain | |
| Primary care Research unit. La Alamedilla health centre | |
| Salamanca., Spain, 37003 | |
| Principal Investigator: | Rodriguez-Sanchez Emiliano, MD | La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain. |
| Study Chair: | Mora-Simón Sara | La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain. |
| Study Chair: | Porras-Santos Nieves | La Alamedilla Health Center, Castilla y León Health Service - SACYL, Salamanca, Spain. |
| Study Chair: | Patino-Alonso M. Carmen, MD | Departamento de Estadística. Universidad de Salamanca. Salamanca. Spain. |
| Study Chair: | Recio-Rodríguez José-Ignacio | La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain |
| Study Chair: | Becerro-Muñoz Concepción, MD | La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain |
| Study Chair: | Pérez-Arachaederra Diana | La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain |
| Study Chair: | Gómez-Marcos Manuel-Ángel, md | La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain |
| Study Director: | García Ortiz Luís, MD | La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain |
More Information
Additional Information:
No publications provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Fundacion para la Investigacion y Formacion en Ciencias de la Salud |
| ClinicalTrials.gov Identifier: | NCT01177696 History of Changes |
| Other Study ID Numbers: | GRS270A08 |
| Study First Received: | July 30, 2010 |
| Last Updated: | August 5, 2010 |
| Health Authority: | Spain: Ethics Committee |
Keywords provided by Fundacion para la Investigacion y Formacion en Ciencias de la Salud:
|
caregivers Family Health Psychotherapeutic Primary Health Care |
Additional relevant MeSH terms:
|
Psychotropic Drugs Central Nervous System Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 16, 2013