Meaning-based Group Counselling for Bereavement

This study is ongoing, but not recruiting participants.

Sponsor:

Collaborators:

McGill University

Canadian Institutes of Health Research (CIHR)

Information provided by (Responsible Party):

Christopher J. MacKinnon, Jewish General Hospital

ClinicalTrials.gov Identifier:

NCT01384942

First received: June 23, 2011

Last updated: August 31, 2012

Last verified: August 2012

History of Changes

Tracking Information
First Received Date ^ICMJE	June 23, 2011
Last Updated Date	August 31, 2012
Start Date ^ICMJE	June 2010
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: August 31, 2012)	Grief [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] 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 ] [ Designated as safety issue: No ] 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
Original Primary Outcome Measures ^ICMJE (submitted: June 28, 2011)	Grief [ Time Frame: 24 weeks ] [ Designated as safety issue: No ] A 2 by 3 repeated-measures factorial ANOVA will be conducted on the pre-test, post-test, and follow-up differences for both the experimental and control group on the following outcome measures Depression: Center for Epidemiologic Studies Depression Scale Anxiety: State-Trait Anxiety Scale Grief: Revised Grief Experience Inventory; Core Bereavement; Hogan Grief Reaction Checklist Meaning: Purpose in Life Test; The Grief and Meaning-Reconstruction Inventory; The Integration of Stressful Life Experiences Scale
Change History	Complete list of historical versions of study NCT01384942 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE	Not Provided
Original Secondary Outcome Measures ^ICMJE	Not Provided
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Meaning-based Group Counselling for Bereavement
Official Title ^ICMJE	The Development and Pilot Testing of Meaning-based Group Counselling Intervention for Bereavement
Brief 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.
Detailed Description	Not Provided
Study Type ^ICMJE	Interventional
Study Phase	Phase 2
Study Design ^ICMJE	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Supportive Care
Condition ^ICMJE	Grief Bereavement
Intervention ^ICMJE	Behavioral: Meaning-Based Bereavement Group A 12 week bereavement counselling group with tasks and themes that focus on re-constructing meaning following death. Behavioral: Conventional Bereavement Group An 8 week traditional bereavement group that follows a more conventional approach to grief support.
Study Arm (s)	Experimental: Meaning-Based Bereavement Group Intervention: Behavioral: Meaning-Based Bereavement Group Active Comparator: Conventional Bereavement Group Intervention: Behavioral: Conventional Bereavement Group
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Active, not recruiting
Estimated Enrollment ^ICMJE	32
Estimated Completion Date	January 2013
Primary Completion Date	March 2012 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	18 Years and older
Accepts Healthy Volunteers	Yes
Contacts ^ICMJE	Contact information is only displayed when the study is recruiting subjects
Location Countries ^ICMJE	Canada

Administrative Information
NCT Number ^ICMJE	NCT01384942
Other Study ID Numbers ^ICMJE	002645
Has Data Monitoring Committee	Not Provided
Responsible Party	Christopher J. MacKinnon, Jewish General Hospital
Study Sponsor ^ICMJE	Jewish General Hospital
Collaborators ^ICMJE	McGill University Canadian Institutes of Health Research (CIHR)
Investigators ^ICMJE	Not Provided
Information Provided By	Jewish General Hospital
Verification Date	August 2012
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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