Effectiveness of a Standardized Bereavement Intervention in Primary Care

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Bereavement, Grief

Intervention / Treatment
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* Behavioral: Primary Bereavement Care
* Behavioral: the current bereavement care in primary care


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Maximum Age: 70 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Behavioral: Primary Bereavement Care<br>* a standardized bereavement intervention in Primary Care<br>* Other names: Grief Intervention in Primary Care;|
| Active Comparator: 2<br> | Behavioral: the current bereavement care in primary care<br>* the non-standardized bereavement care that usually provided family physicians in primary care<br>* Other names: The current grief care in primary care;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Texas Revised Inventory of Grief (TRIG) |  | at 3, 9, 15 and 21 months since death | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Grief Experience Inventory (GEI) |  | at 3, 9, 15 and 21 months since death | 
| General Health Questionnaire - 28 items (GHQ-28) |  | at 3, 9, 15 and 21 months since death | 
| SF-36 Health Profile (SF-36) |  | at 3, 9, 15 and 21 months since death | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Randomized controlled trial, Primary Care