CClinicalTrials.gg
CompletedNCT00133263Updated Jul 10, 2014

Effectiveness of a Standardized Bereavement Intervention in Primary Care

A Phase 3 interventional study of Primary Bereavement Care and the current bereavement care in primary care in Bereavement and Grief, sponsored by Carlos III Health Institute. Completed at 1 site in Spain. Open to female participants aged Up to 70 Years. Per ClinicalTrials.gov, last updated 2014-07-10.

Sponsored by Carlos III Health Institute · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
87
Allocation
Randomized
Ages
Up to 70 Years
Sex
Female
01

Study 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.

Read the 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.

02

Conditions studied

  • Bereavement
  • Grief

Keywords

  • Randomized controlled trial
  • Primary Care
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In context

Lead sponsor

Carlos III Health Institute is the lead sponsor of 5 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
Up to 70 Years
Sexes eligible
Female
Accepts healthy volunteers
No

Inclusion criteria

  • Partner death during the last 3 months.

Exclusion criteria

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.
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
87 participants (actual)

Study arms

  • Experimental
    1

    Behavioral: Primary Bereavement Care

  • Active comparator
    2

    Behavioral: the current bereavement care in primary care

Interventions

  • BehavioralPrimary Bereavement Care

    a standardized bereavement intervention in Primary Care

    Also known as: Bereavement Primary Care, Bereavement Intervention in Primary Care, Grief Intervention in Primary Care

  • Behavioralthe current bereavement care in primary care

    the non-standardized bereavement care that usually provided family physicians in primary care

    Also known as: The current grief care in primary care

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What researchers measure

Primary outcomes

  1. Texas Revised Inventory of Grief (TRIG)

    Time frame: at 3, 9, 15 and 21 months since death

Secondary outcomes

  1. Grief Experience Inventory (GEI)

    Time frame: at 3, 9, 15 and 21 months since death

  2. General Health Questionnaire - 28 items (GHQ-28)

    Time frame: at 3, 9, 15 and 21 months since death

  3. SF-36 Health Profile (SF-36)

    Time frame: at 3, 9, 15 and 21 months since death

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Study locations

1 site
  • Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza
    Bilbao, Bizkaia 48014, Spain
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References and documents

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. PubMed 15871796 ↗
  • 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. PubMed 11256097 ↗
  • 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. PubMed 9280441 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jul 10, 2014, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00133263
Lead sponsor
Carlos III Health Institute
Collaborators
Health Department of the Basque Government
First posted
Aug 23, 2005
Start date
Jan 2001
Primary completion
Apr 2005
Completion
Dec 2006
Last update
Jul 10, 2014

Study contacts

Jesus A. Garcia, MD
principal investigator · Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Mar 2008. You cannot join it, but the record below documents what was studied.

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