Effectiveness of a Standardized Bereavement Intervention in Primary Care

Phase 3

Completed

• Conditions: Bereavement; Grief
• Interventions: Behavioral: Primary Bereavement Care; Behavioral: the current bereavement care in primary care

• Registration Number: NCT00133263
• Lead Sponsor: Carlos III Health Institute

Brief 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.

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 Timeline

• Study Start: 2001-01
• Primary Completion: 2005-04
• Study First Submitted: 2005-08-22
• Study First Submitted QC: 2005-08-22
• Study First Posted: 2005-08-23
• Study Completion: 2006-12
• Status Verified: 2008-03
• Last Update Submitted: 2014-07-09
• Last Update Posted: 2014-07-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 87

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

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
1	Primary Bereavement Care	-
2	the current bereavement care in primary care	-

Primary Outcome Measures

Name	Time	Method
Texas Revised Inventory of Grief (TRIG)	at 3, 9, 15 and 21 months since death

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza; 🇪🇸 Bilbao, Bizkaia, Spain