Effectiveness of a Standardized Bereavement Intervention in Primary Care

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

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.

Study Overview

• Status: Completed
• Conditions: Grief; Bereavement
• Intervention / Treatment: Behavioral: Primary Bereavement Care; Behavioral: the current bereavement care in primary care

Detailed 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.

• Study Type: Interventional
• Enrollment (Actual): 87
• Phase: Phase 3

Contacts and Locations

Study Locations

• Spain
  • Bizkaia
    • Bilbao, Bizkaia, Spain, 48014
      • Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 70 years (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 1	Behavioral: Primary Bereavement Care; a standardized bereavement intervention in Primary Care; Other Names: Bereavement Primary Care; Bereavement Intervention in Primary Care; Grief Intervention in Primary Care
Active Comparator: 2	Behavioral: the current bereavement care in primary care; the non-standardized bereavement care that usually provided family physicians in primary care; Other Names: The current grief care in primary care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Texas Revised Inventory of Grief (TRIG)	at 3, 9, 15 and 21 months since death

Secondary Outcome Measures

Outcome Measure	Time Frame
Grief Experience Inventory (GEI)	at 3, 9, 15 and 21 months since death
General Health Questionnaire - 28 items (GHQ-28)	at 3, 9, 15 and 21 months since death
SF-36 Health Profile (SF-36)	at 3, 9, 15 and 21 months since death

Collaborators and Investigators

• Sponsor: Carlos III Health Institute
• Collaborators: Health Department of the Basque Government
• Investigators: Principal Investigator: Jesus A. Garcia, MD, Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.

Publications and helpful links

General Publications

• Garcia Garcia 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. doi: 10.1157/13074293. Spanish.
• Garcia-Garcia 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. doi: 10.1016/s0212-6567(01)78779-3. Spanish.
• Garcia-Garcia 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.

Helpful Links

• 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.

Study record dates

Study Major Dates

• Study Start: January 1, 2001
• Primary Completion (Actual): April 1, 2005
• Study Completion (Actual): December 1, 2006

Study Registration Dates

• First Submitted: August 22, 2005
• First Submitted That Met QC Criteria: August 22, 2005
• First Posted (Estimate): August 23, 2005

Study Record Updates

• Last Update Posted (Estimate): July 10, 2014
• Last Update Submitted That Met QC Criteria: July 9, 2014
• Last Verified: March 1, 2008

More Information

Terms related to this study

• Keywords: Primary Care; Randomized controlled trial
• Other Study ID Numbers: PI020827; 200011007