Effectiveness of a Standardized Bereavement Intervention in Primary Care

Bereavement Clinical Trial

Official title:

Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00133263
• Other study ID #: PI020827
• Secondary ID: 200011007
• Status: Completed
• Phase: Phase 3
• First received: August 22, 2005
• Last updated: July 9, 2014
• Start date: January 2001
• Est. completion date: December 2006

Study information

• Verified date: March 2008
• Source: Carlos III Health Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Ministry of Health and Consumption
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of "Primary Bereavement Care" (PBC) -a standardized bereavement intervention- delivered by family physicians (FP), in widows.

Description:

Nowadays there is little evidence about what is the best bereavement intervention in primary care and each family physician (FP) assists bereaved people in a different way. The death of a loved one is the most stressful life event that can face a person; in fact, bereavement is associated with an increased risk of depression, generalized anxiety and panic disorder, alcohol abuse and use of medications, sudden cardiac events, suicide, and an increased demand for health resources. The FP is the only specialist who -through his position in the health system and in the community- can give emotional support to the bereaved and simultaneously deal with the health problems associated with the process. In response to this, our work group has designed a guide specifically for FP: Primary Bereavement Care (PBC), and is currently testing its efficacy in a randomized controlled study.

Comparison (s): Recently widows attended by FP trained in PBC through seven PBC sessions, compared to recently widows attended by FP not trained in PBC through seven "ordinary" sessions.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: December 2006
• Est. primary completion date: April 2005
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A to 70 Years

Eligibility

Inclusion Criteria:

• Partner death during the last 3 months.

Exclusion Criteria:

• Partner death through suicide or AIDS.

• Son or daughter death during the last 3 years.

• Parent or sibling death the year before.

• Alcohol or drug abuse.

• Psychotic disorder or dementia.

• To be confined to bed

• Illiteracy.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Bereavement
• Grief

Intervention

Behavioral:
• Primary Bereavement Care
a standardized bereavement intervention in Primary Care
• the current bereavement care in primary care
the non-standardized bereavement care that usually provided family physicians in primary care

Locations

Country	Name	City	State
Spain	Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza	Bilbao	Bizkaia

Sponsors (2)

Lead Sponsor	Collaborator
Carlos III Health Institute	Health Department of the Basque Government

Country where clinical trial is conducted

Spain, 

References & Publications (3)

García García JA, Landa Petralanda V, Trigueros Manzano MC, Gaminde Inda I. [Texas revised inventory of grief: adaptation to Spanish, reliability and validity]. Aten Primaria. 2005 Apr 30;35(7):353-8. Spanish. — View Citation

García-García JA, Landa Petralanda V, Trigueros Manzano MC, Calvo Aedo P, Gaminde Inda I. [Grief for loss of a spouse: a study with discussion groups in primary care]. Aten Primaria. 1996 Nov 30;18(9):475-9. Spanish. — View Citation

García-García JA, Landa Petralanda V, Trigueros Manzano MC, Gaminde Inda I. [Inventory of experiences in grief (IEG): adaptation to Spanish, reliability and validity]. Aten Primaria. 2001 Feb 15;27(2):86-93. Spanish. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Texas Revised Inventory of Grief (TRIG)		at 3, 9, 15 and 21 months since death	Yes
Secondary	Grief Experience Inventory (GEI)		at 3, 9, 15 and 21 months since death	Yes
Secondary	General Health Questionnaire - 28 items (GHQ-28)		at 3, 9, 15 and 21 months since death	Yes
Secondary	SF-36 Health Profile (SF-36)		at 3, 9, 15 and 21 months since death	Yes

External Links

•   In this presentation we explain the rationale of Primary Bereavement Care (PBC) and the PBC general techniques (REFINO), and summarize the project.
•   Landa V, García JA. Duelo. Guías Clínicas. Cuidados Primarios de Duelo. 2011. This is a summary in Spanish of the intervention - Primary Bereavement Care - which is used in our project.