NCT03177772

Brief Summary

The investigators are adapting Complicated Grief Group Therapy (CGGT) for soon-to-be bereaved dementia caregivers at risk for complicated grief-Pre-Loss Group Therapy (PLGT) to facilitate healthy death preparedness and eventual bereavement. This will be the first known application of proven therapeutic strategies to address complicated grief applied to high-risk dementia caregivers prior to care recipient death to mitigate complicated grief. If proven to be effective in attenuating poor bereavement outcomes, PLGT could be translated into comprehensive caregiver support programs and delivered to active caregivers of living persons with dementia at risk for complicated grief through community-based caregiver support groups.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
80

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Mar 2018

Typical duration for all trials

Geographic Reach
1 country

3 active sites

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

First Submitted

Initial submission to the registry

May 26, 2017

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 6, 2017

Completed
9 months until next milestone

Study Start

First participant enrolled

March 1, 2018

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 28, 2021

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2021

Completed
Last Updated

November 23, 2021

Status Verified

November 1, 2021

Enrollment Period

3.2 years

First QC Date

May 26, 2017

Last Update Submit

November 22, 2021

Conditions

Keywords

caregiversgriefdementialong-term carepsychotherapy group

Outcome Measures

Primary Outcomes (1)

  • Grief

    Change in pre-loss grief as measured by Inventory of Complicated Grief-revised (Prigerson, et al., 1995; ICG-r)

    3 months post death of care recipient

Secondary Outcomes (2)

  • Meaning Making

    3 months post death of care recipient

  • Preparedness

    3 months post death of care recipient

Study Arms (3)

LTC Facility 1

Pre-loss Grief Support Group offered in long-term care facility for dementia family caregivers anticipating the death of their care recipient within next 6 month. Two hour sessions for 10 weeks include psychoeducation, motivational interviewing, cognitive behavioral and exposure approaches. Supportive others, selected by participants are included in two sessions.

Behavioral: Pre-loss group therapy

LTC Facility 2

Pre-loss Grief Support Group offered in long-term care facility for dementia family caregivers anticipating the death of their care recipient within next 6 month. Two hour sessions for 10 weeks include psychoeducation, motivational interviewing, cognitive behavioral and exposure approaches. Supportive others, selected by participants are included in two sessions.

Behavioral: Pre-loss group therapy

LTC Facility 3

Pre-loss Grief Support Group offered in long-term care facility for dementia family caregivers anticipating the death of their care recipient within next 6 month. Two hour sessions for 10 weeks include psychoeducation, motivational interviewing, cognitive behavioral and exposure approaches. Supportive others, selected by participants are included in two sessions.

Behavioral: Pre-loss group therapy

Interventions

The PLGT intervention will include CGGT treatment elements modified to address the pre-loss preparation of caregivers at risk for complicated grief, and will focus on the perceived relationship and attachment status between caregiver and care recipient, how memories of the life together, the illness and the death are interpreted, and strategies for preparing for life without the care recipient. These activities include elements of motivational interviewing, cognitive behavioral therapy and prolonged exposure therapy.

LTC Facility 1LTC Facility 2LTC Facility 3

Eligibility Criteria

Age18 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Study participants will be ADRD caregivers at risk for CG with a family member diagnosed with ADRD having a life expectancy of less than 6 months and residing in one of three partner Long-term care the facilities

You may qualify if:

  • resident ADRD diagnosis,
  • life expectancy, "Would you be surprised if this resident died in the next 6 months?" and
  • minimum score of 4 on p-BGQ, and
  • positive scores on 4 of 9 risk factors will qualify

You may not qualify if:

  • Active suicidality (likely hospitalization) will exclude interested individuals from participating

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (3)

St. Joseph Villa

Salt Lake City, Utah, 84115, United States

Location

Silverado Care Facility

Salt Lake City, Utah, 84117, United States

Location

William E. Christoffersen Veterans Home

Salt Lake City, Utah, 84148, United States

Location

MeSH Terms

Conditions

Dementia

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System DiseasesNeurocognitive DisordersMental Disorders

Study Design

Study Type
observational
Observational Model
ECOLOGIC OR COMMUNITY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

May 26, 2017

First Posted

June 6, 2017

Study Start

March 1, 2018

Primary Completion

May 28, 2021

Study Completion

August 30, 2021

Last Updated

November 23, 2021

Record last verified: 2021-11

Locations