NCT01177696

Brief 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. 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
150

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Sep 2008

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2008

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2009

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 30, 2010

Completed
10 days until next milestone

First Posted

Study publicly available on registry

August 9, 2010

Completed
23 days until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
Last Updated

August 9, 2010

Status Verified

August 1, 2010

Enrollment Period

9 months

First QC Date

July 30, 2010

Last Update Submit

August 5, 2010

Conditions

Keywords

caregiversFamily HealthPsychotherapeuticPrimary Health Care

Outcome Measures

Primary Outcomes (1)

  • 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.

    Initial and 6 months later

Study Arms (2)

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.

Behavioral: Psychotherapeutic intervention

Control

NO INTERVENTION

Interventions

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.

Also known as: Received usual care.
psychotherapy

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Caregivers: They provide mostly all the assistance to care-dependent familiars receiving attention in PHC Centers

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Primary care Research unit. La Alamedilla health centre

Salamanca, Salamanca., 37003, Spain

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Psychological Well-Being

Condition Hierarchy (Ancestors)

Personal SatisfactionBehavior

Study Officials

  • Rodriguez-Sanchez Emiliano, MD

    La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain.

    PRINCIPAL INVESTIGATOR
  • 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 CHAIR
  • García Ortiz Luís, MD

    La Alamedilla Health Center, Castilla-León Health Service - SACYL, Salamanca, Spain

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

July 30, 2010

First Posted

August 9, 2010

Study Start

September 1, 2008

Primary Completion

June 1, 2009

Study Completion

September 1, 2010

Last Updated

August 9, 2010

Record last verified: 2010-08

Locations