Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Meaning-based Group Counselling for Bereavement

This study has been completed.
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: November 7, 2013
Last verified: August 2013
  Purpose

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.


Condition Intervention Phase
Grief
Bereavement
Behavioral: Meaning-Based Bereavement Group
Behavioral: Conventional Bereavement Group
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
Official Title: The Development and Pilot Testing of Meaning-based Group Counselling Intervention for Bereavement

Resource links provided by NLM:


Further study details as provided by Jewish General Hospital:

Primary Outcome Measures:
  • 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 ] [ 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) Depression: Center for Epidemiologic Studies Depression Scale


  • Anxiety [ 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)Anxiety: State-Trait Anxiety Scale



Enrollment: 26
Study Start Date: June 2010
Study Completion Date: October 2013
Primary Completion Date: March 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Meaning-Based Bereavement Group Behavioral: 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 Behavioral: Conventional Bereavement Group
An 8 week traditional bereavement group that follows a more conventional approach to grief support.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01384942

Locations
Canada, Quebec
S.M.B.D. Jewish General Hospital / Hope and Cope Program
Montreal, Quebec, Canada, H3T 1E2
Sponsors and Collaborators
Jewish General Hospital
McGill University
Canadian Institutes of Health Research (CIHR)
  More Information

No publications provided

Responsible Party: Christopher J. MacKinnon, Psychologist, Jewish General Hospital
ClinicalTrials.gov Identifier: NCT01384942     History of Changes
Obsolete Identifiers: NCT01285128
Other Study ID Numbers: 002645
Study First Received: June 23, 2011
Last Updated: November 7, 2013
Health Authority: Canada: Ethics Review Committee

Keywords provided by Jewish General Hospital:
Bereavement
Grief
Mourning
Loss
Death
Meaning
Group
Counseling
Psychotherapy
Uncomplicated
Support

ClinicalTrials.gov processed this record on November 20, 2014