BereavementPhase 3NCT00133263
Effectiveness of a Standardized Bereavement Intervention in Primary Care
A Phase 3 study testing Primary Bereavement Care and the current bereavement care in primary care in people with Bereavement and Grief, run by Carlos III Health Institute at 1 site in Spain.
Trial 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 more about this study
- Who is it for?
- Ages Up to 70 years, women only
- Conditions the study is for
- Bereavement, Grief
- What is being tested?
- Primary Bereavement Care and the current bereavement care in primary care
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 87 participants
- Where
- 1 siteSpain
- Study dates
- Jan 2001to Dec 2006
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 70 years
- Women only
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Partner death during the last 3 months.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Spain1 site
Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza
Bilbao, Bizkaia, 48014
About this study
Official title: Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial
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.
- Conditions
- Bereavement, Grief
- Being tested
- Primary Bereavement Care, the current bereavement care in primary care
- Keywords
- Randomized controlled trial, Primary Care
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Primary Bereavement CareBehavioural
Also called Bereavement Primary Care, Bereavement Intervention in Primary Care, Grief Intervention in Primary Care
a standardized bereavement intervention in Primary Care
the current bereavement care in primary careBehavioural
Also called The current grief care in primary care
the non-standardized bereavement care that usually provided family physicians in primary care
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Not described Receives: Behavioral: Primary Bereavement Care |
| 2 | Active comparator | Not described Receives: Behavioral: the current bereavement care in primary care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Texas Revised Inventory of Grief (TRIG)
Measured: at 3, 9, 15 and 21 months since death
Secondary outcomes (3)
Grief Experience Inventory (GEI)
Measured: at 3, 9, 15 and 21 months since death
General Health Questionnaire - 28 items (GHQ-28)
Measured: at 3, 9, 15 and 21 months since death
SF-36 Health Profile (SF-36)
Measured: at 3, 9, 15 and 21 months since death
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Aug 2005 (estimated)
- Study startJan 2001
- Primary completionApr 2005
- Study completionDec 2006
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for BereavementStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 87 participants (actual)
Sponsor and investigators
- Lead sponsor
- Carlos III Health Institute
- Sponsor type
- Other government
- Collaborators
- Basque Government Department of Public Health
- Investigators
- Jesus A. Garcia, MD, Principal investigator, Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00133263
- Sponsor's protocol ID
- PI020827
- Other IDs
- 200011007
- Status last verified
- Mar 2008
- First submitted
- 22 Aug 2005
- Last updated
- 10 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
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 15871796Garcia-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 11256097Garcia-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
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of "Primary Bereavement Care" (PBC) in Widows: A Cluster Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT00133263
- Acronym / sponsor ID
- PI020827
- Conditions
- Bereavement, Grief
- Keywords
- Randomized controlled trial, Primary Care
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 87 participants (actual)
- Lead sponsor
- Carlos III Health InstituteOther government
- Collaborators
- Basque Government Department of Public Health
- Study start
- Jan 2001
- Primary completion
- Apr 2005 (actual)
- Study completion
- Dec 2006 (actual)
- First posted
- 23 Aug 2005 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Behavioral: Primary Bereavement Care |
| 2 | Active comparator | Behavioral: the current bereavement care in primary care |
Who may qualify
- Ages
- Up to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (1 listed)
- Partner death during the last 3 months.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Primary Bereavement CareAlso: Bereavement Primary Care, Bereavement Intervention in Primary Care, Grief Intervention in Primary Carea standardized bereavement intervention in Primary Care | Behavioural | 1 |
| the current bereavement care in primary careAlso: The current grief care in primary carethe non-standardized bereavement care that usually provided family physicians in primary care | Behavioural | 2 |
Primary outcome
Texas Revised Inventory of Grief (TRIG)
Time frame: at 3, 9, 15 and 21 months since death
3 secondary outcomes
Grief Experience Inventory (GEI)
Time frame: at 3, 9, 15 and 21 months since death
General Health Questionnaire - 28 items (GHQ-28)
Time frame: at 3, 9, 15 and 21 months since death
SF-36 Health Profile (SF-36)
Time frame: at 3, 9, 15 and 21 months since death
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jul 2014.
- Background: PubMed 15871796Garcia 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.
- Background: PubMed 11256097Garcia-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.
- Background: PubMed 9280441Garcia-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.
- 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.Link provided by the sponsor.
Related trials for Bereavement
Recruiting
Risk and Resilience to Suicide Following Late-Life Spousal Bereavement
Suicide, Bereavement
Active, not recruiting
Musical Playlist of the Grief Journey
Music Therapy, Bereavement
Recruiting
Support for Bereaved Cancer Caregivers
Bereavement, Cancer
Not yet recruiting
Family-authored Digital ICU Diary Intervention to Support Bereaved Family Members in Intensive Care Unit: A Pilot Mixed Methods Study
Bereavement
Not yet recruiting
Comparison of Social Media-Based and Online Training in Grief Counseling Education
Perinatal Grief, Perinatal Loss
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jesus A. Garcia, MD principal investigator
Primary Care Research Unit of Bizkaia, Basque Health Service/Osakidetza.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Primary Bereavement Care and the current bereavement care in primary care in people with Bereavement and Grief, run by Carlos III Health Institute at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Texas Revised Inventory of Grief (TRIG) (time frame: at 3, 9, 15 and 21 months since death). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00133263, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Jul 2014; AzTrials last refreshed its copy on 6 Nov 2026.