- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01384942
Meaning-based Group Counselling for Bereavement
The Development and Pilot Testing of Meaning-based Group Counselling Intervention for Bereavement
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
-
-
Quebec
-
Montreal, Quebec, Canada, H3T 1E2
- S.M.B.D. Jewish General Hospital / Hope and Cope Program
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: SUPPORTIVE_CARE
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: NONE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Meaning-Based Bereavement Group
|
A 12 week bereavement counselling group with tasks and themes that focus on re-constructing meaning following death.
|
|
Active Comparator: Conventional Bereavement Group
|
An 8 week traditional bereavement group that follows a more conventional approach to grief support.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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 |
24 weeks
|
|
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 |
24 weeks
|
|
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 |
24 Weeks
|
|
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 |
24 Weeks
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- 002645
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.