Effectiveness of a Standardized Bereavement Intervention in Primary Care

• Sponsor: Carlos III Health Institute (Other)
• Overall Status: Completed
• CT.gov ID: NCT00133263
• Collaborator: Health Department of the Basque Government (Other)
• Enrollment: 87
• Location: 1
• Arms: 2
• Duration (Months): 71
• Patients Per Site Per Month: 1.2

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bereavement; Grief	Behavioral: Primary Bereavement Care; Behavioral: the current bereavement care in primary care	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 87 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial
• Study Start Date: Jan 1, 2001
• Actual Primary Completion Date: Apr 1, 2005
• Actual Study Completion Date: Dec 1, 2006

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

1. Texas Revised Inventory of Grief (TRIG) [at 3, 9, 15 and 21 months since death]

Secondary Outcome Measures

1. Grief Experience Inventory (GEI) [at 3, 9, 15 and 21 months since death]

2. General Health Questionnaire - 28 items (GHQ-28) [at 3, 9, 15 and 21 months since death]

3. SF-36 Health Profile (SF-36) [at 3, 9, 15 and 21 months since death]

Eligibility Criteria

Criteria

• Ages Eligible for Study: N/A to 70 Years
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza	Bilbao	Bizkaia	Spain	48014

Sponsors and Collaborators

• Carlos III Health Institute
• Health Department of the Basque Government

Investigators

• Principal Investigator: Jesus A. Garcia, MD, Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

• 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.

Publications

• 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.
• 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.
• 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.

• ClinicalTrials.gov Identifier: NCT00133263
• Other Study ID Numbers: PI020827; 200011007
• First Posted: Aug 23, 2005
• Last Update Posted: Jul 10, 2014
• Last Verified: Mar 1, 2008

• Keywords provided by , ,: Randomized controlled trial; Primary Care

Study Results

No Results Posted as of Jul 10, 2014