Meaning-based Group Counselling for Bereavement

Grief Clinical Trial

Official title:

The Development and Pilot Testing of Meaning-based Group Counselling Intervention for Bereavement

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01384942
• Other study ID #: 002645
• Status: Completed
• Phase: Phase 2
• First received: June 23, 2011
• Last updated: November 7, 2013
• Start date: June 2010
• Est. completion date: October 2013

Study information

• Verified date: August 2013
• Source: Jewish General Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical 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. 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.

Other known NCT identifiers

• NCT01285128

Recruitment information / eligibility

• Status: Completed
• Enrollment: 26
• Est. completion date: October 2013
• Est. primary completion date: March 2012
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Bereavement
• Grief

Intervention

Behavioral:
• Meaning-Based Bereavement Group
A 12 week bereavement counselling group with tasks and themes that focus on re-constructing meaning following death.
• Conventional Bereavement Group
An 8 week traditional bereavement group that follows a more conventional approach to grief support.

Locations

Country	Name	City	State
Canada	S.M.B.D. Jewish General Hospital / Hope and Cope Program	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
Jewish General Hospital	Canadian Institutes of Health Research (CIHR), McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	24 weeks	No
Primary	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	24 weeks	No
Primary	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	24 Weeks	No
Primary	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	24 Weeks	No