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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01384942
Other study ID # 002645
Secondary ID
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


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
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