GriefPhase 2NCT01384942
Meaning-based Group Counselling for Bereavement
A Phase 2 study testing Meaning-Based Bereavement Group and Conventional Bereavement Group in people with Grief and Bereavement, run by Jewish General Hospital at 1 site in Canada.
Trial summary
Given that individuals in bereavement tend to experience substantial psychological distress in the first two years following loss, individuals seeking psychological support will need appropriate services grounded in sound empirical scholarship. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Grief, Bereavement
- What is being tested?
- Meaning-Based Bereavement Group and Conventional Bereavement Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteCanada
- Study dates
- Jun 2010to Oct 2013
- Phase
- Phase 2
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals presenting for bereavement services that have experienced a death-related loss within 6 weeks to 2 years of the first meeting of the group, and are experiencing an uncomplicated grief response will be invited to participate.
- Individuals will be assessed for their ability to participate in a group counselling context as well as an uncomplicated grief trajectory. Participants must be 18 years of age or older, have sufficient ability to communicate in English, as well as read English.
Who cannot join
- Following a clinical/diagnostic interview and administration of the PG-13 (Prolonged Grief Disorder-13, Prigerson et al., 2009), individuals experiencing a complicated/prolonged grief trajectory are excluded.
- Furthermore, individuals whose cognitive condition might make the study burdensome or impossible for them are excluded.
Trial locations and contacts
1 site in 1 country.
Canada1 site
S.M.B.D. Jewish General Hospital / Hope and Cope Program
Montreal, Quebec, H3T 1E2
About this study
Official title: The Development and Pilot Testing of Meaning-based Group Counselling Intervention for Bereavement
Given that individuals in bereavement tend to experience substantial psychological distress in the first two years following loss, individuals seeking psychological support will need appropriate services grounded in sound empirical scholarship. There is a lack of studies assessing bereavement groups, despite groups being one of the most common forms by which such services are offered. The prominent and emerging process of meaning-reconstruction in bereavement research is theorized to lead to better psychological adjustment and prevent more prolonged grief reactions. The principal objective of this study is to compare two types of group counseling for individuals in bereavement: A novel meaning-based bereavement counseling group and a conventional bereavement support group.
- Conditions
- Grief, Bereavement
- Being tested
- Meaning-Based Bereavement Group, Conventional Bereavement Group
- Keywords
- Bereavement, Grief, Mourning, Loss, Death, Meaning, Group, Counseling, Psychotherapy, Uncomplicated, Support
- Medical subject headings
- Death
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Meaning-Based Bereavement GroupBehavioural
A 12 week bereavement counselling group with tasks and themes that focus on re-constructing meaning following death.
Conventional Bereavement GroupBehavioural
An 8 week traditional bereavement group that follows a more conventional approach to grief support.
| Study group | Role | What they receive |
|---|---|---|
| Meaning-Based Bereavement Group | Experimental | Not described Receives: Behavioral: Meaning-Based Bereavement Group |
| Conventional Bereavement Group | Active comparator | Not described Receives: Behavioral: Conventional Bereavement Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grief
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures
(1) Grief: Revised Grief Experience Inventory; Core Bereavement; Hogan Grief Reaction Checklist
Measured: 24 weeks
Meaning
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures
(1) Meaning: Purpose in Life Test; The Grief and Meaning-Reconstruction Inventory; The Integration of Stressful Life Experiences Scale
Measured: 24 weeks
Depression
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures
(1) Depression: Center for Epidemiologic Studies Depression Scale
Measured: 24 Weeks
Anxiety
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures
(1)Anxiety: State-Trait Anxiety Scale
Measured: 24 Weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2011 (estimated)
- Study startJun 2010
- Primary completionMar 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies 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 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jewish General Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- McGill University, Canadian Institutes of Health Research (CIHR)
- Responsible party
- Principal investigator, Christopher J. MacKinnon, Jewish General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01384942
- Sponsor's protocol ID
- 002645
- Status last verified
- Aug 2013
- First submitted
- 23 Jun 2011
- Last updated
- 8 Nov 2013
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Development and Pilot Testing of Meaning-based Group Counselling Intervention for Bereavement
- ClinicalTrials.gov ID
- NCT01384942
- Acronym / sponsor ID
- 002645
- Conditions
- Grief, Bereavement
- Keywords
- Bereavement, Grief, Mourning, Loss, Death, Meaning, Group, Counseling
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Jewish General HospitalUniversity, hospital or other
- Collaborators
- McGill University, Canadian Institutes of Health Research (CIHR)
- Study start
- Jun 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 29 Jun 2011 (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.
Given that individuals in bereavement tend to experience substantial psychological distress in the first two years following loss, individuals seeking psychological support will need appropriate services grounded in sound empirical scholarship. There is a lack of studies assessing bereavement groups, despite groups being one of the most common forms by which such services are offered. The prominent and emerging process of meaning-reconstruction in bereavement research is theorized to lead to better psychological adjustment and prevent more prolonged grief reactions. The principal objective of this study is to compare two types of group counseling for individuals in bereavement: A novel meaning-based bereavement counseling group and a conventional bereavement support group.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Meaning-Based Bereavement Group | Experimental | Behavioral: Meaning-Based Bereavement Group |
| Conventional Bereavement Group | Active comparator | Behavioral: Conventional Bereavement Group |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Individuals presenting for bereavement services that have experienced a death-related loss within 6 weeks to 2 years of the first meeting of the group, and are experiencing an uncomplicated grief response will be invited to participate.
- Individuals will be assessed for their ability to participate in a group counselling context as well as an uncomplicated grief trajectory. Participants must be 18 years of age or older, have sufficient ability to communicate in English, as well as read English.
Key exclusion criteria (2 listed)
- Following a clinical/diagnostic interview and administration of the PG-13 (Prolonged Grief Disorder-13, Prigerson et al., 2009), individuals experiencing a complicated/prolonged grief trajectory are excluded.
- Furthermore, individuals whose cognitive condition might make the study burdensome or impossible for them are excluded.
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 |
|---|---|---|
| Meaning-Based Bereavement GroupA 12 week bereavement counselling group with tasks and themes that focus on re-constructing meaning following death. | Behavioural | Meaning-Based Bereavement Group |
| Conventional Bereavement GroupAn 8 week traditional bereavement group that follows a more conventional approach to grief support. | Behavioural | Conventional Bereavement Group |
Primary outcome
Grief
Time frame: 24 weeks
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures (1) Grief: Revised Grief Experience Inventory; Core Bereavement; Hogan Grief Reaction Checklist
Meaning
Time frame: 24 weeks
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures (1) Meaning: Purpose in Life Test; The Grief and Meaning-Reconstruction Inventory; The Integration of Stressful Life Experiences Scale
Depression
Time frame: 24 Weeks
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures (1) Depression: Center for Epidemiologic Studies Depression Scale
Anxiety
Time frame: 24 Weeks
Descriptive statistical analysis (e.g., means, standard deviations, percentage of scale range improvements) will be conducted on the pre-test, post-test, and follow-up scores for both the experimental and control group on the following outcome measures (1)Anxiety: State-Trait Anxiety Scale
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 8 Nov 2013.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Meaning-Based Bereavement Group and Conventional Bereavement Group in people with Grief and Bereavement, run by Jewish General Hospital at 1 site in Canada.
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 2 inclusion and 2 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 8 Nov 2013. 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 Canada. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Grief (time frame: 24 weeks). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 8 Nov 2013.