Clinical trial NCT00133263: Effectiveness of a Standardized Bereavement Intervention in Primary Care
Official title: Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Bereavement
Grief
Keywords: Randomized controlled trial
Primary Care
Lead sponsor: Carlos III Health Institute
Sponsor class: OTHER_GOV
Collaborators: name: Health Department of the Basque Government
First posted: 2005-08-23
Enrollment: 87
Sex: FEMALE
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: Texas Revised Inventory of Grief (TRIG)
timeFrame: at 3, 9, 15 and 21 months since death
Secondary outcomes:
measure: Grief Experience Inventory (GEI)
timeFrame: at 3, 9, 15 and 21 months since death
measure: General Health Questionnaire - 28 items (GHQ-28)
timeFrame: at 3, 9, 15 and 21 months since death
measure: SF-36 Health Profile (SF-36)
timeFrame: at 3, 9, 15 and 21 months since death
Other outcomes:
Locations:
city: Bilbao
country: Spain
facility: Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza
state: Bizkaia
Study officials:
affiliation: Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.
name: Jesus A. Garcia, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.