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Completed

NCT Number: NCT00133263

Effectiveness of a Standardized Bereavement Intervention in Primary Care

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.

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Key information

Conditions

Bereavement Grief

Age range

Up to 70 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza

Bilbao, Bizkaia, 48014, Spain

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary Bereavement Care

Behavioral

a standardized bereavement intervention in Primary Care

Other names: Bereavement Primary Care, Bereavement Intervention in Primary Care, Grief Intervention in Primary Care

the current bereavement care in primary care

Behavioral

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

Other names: The current grief care in primary care

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

Sponsors and collaborators

Lead sponsor

Carlos III Health Institute

Other Gov

Collaborators

  • Basque Government Department of Public Health

Registry information

Official study title

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

Important dates

Study start
2001
Primary completion
2005
Study completion
2006
First posted
Aug 23, 2005
Registry last updated
Jul 10, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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