NCT01384942

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
26

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2010

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2010

Completed
1.1 years until next milestone

First Submitted

Initial submission to the registry

June 23, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 29, 2011

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2012

Completed
1.6 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2013

Completed
Last Updated

November 8, 2013

Status Verified

August 1, 2013

Enrollment Period

1.8 years

First QC Date

June 23, 2011

Last Update Submit

November 7, 2013

Conditions

Keywords

BereavementGriefMourningLossDeathMeaningGroupCounselingPsychotherapyUncomplicatedSupport

Outcome Measures

Primary Outcomes (4)

  • 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

  • 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

  • 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

  • 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

Study Arms (2)

Meaning-Based Bereavement Group

EXPERIMENTAL
Behavioral: Meaning-Based Bereavement Group

Conventional Bereavement Group

ACTIVE COMPARATOR
Behavioral: Conventional Bereavement Group

Interventions

A 12 week bereavement counselling group with tasks and themes that focus on re-constructing meaning following death.

Meaning-Based Bereavement Group

An 8 week traditional bereavement group that follows a more conventional approach to grief support.

Conventional Bereavement Group

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

S.M.B.D. Jewish General Hospital / Hope and Cope Program

Montreal, Quebec, H3T 1E2, Canada

Location

MeSH Terms

Conditions

Death

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Psychologist

Study Record Dates

First Submitted

June 23, 2011

First Posted

June 29, 2011

Study Start

June 1, 2010

Primary Completion

March 1, 2012

Study Completion

October 1, 2013

Last Updated

November 8, 2013

Record last verified: 2013-08

Locations