Group Therapy For Dementia Caregivers At Risk For Complicated Grief

Grief Clinical Trial

— PLGT  

Official title:

Group Therapy For Dementia Caregivers At Risk For Complicated Grief

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03177772
• Other study ID #: AARG-17-503706
• Status: Completed
• Start date: March 1, 2018
• Est. completion date: August 30, 2021

Study information

• Verified date: November 2021
• Source: University of Utah
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Description:

In the investigators previous evaluation of Complicated Grief Group Therapy (CGGT) in bereaved dementia caregivers (2014-NIRG-305569), CGGT was administered to participants in a prospective, randomized-controlled trial. Participants in 5 treatment groups confirmed clinically significant reduction in complicated grief on the Inventory of Complicated Grief. In that study, intervention elements suitable for adaption in a preventative care approach were identified. The investigators are adapting these elements of 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.

Specific Aims: 1) Assess preparedness for death and grief of bereaved and soon-to-be bereaved caregivers. 2) Adapt CGGT treatment elements into a manualized pre-loss preparedness group psychotherapy-(PLGT)-for dementia caregivers at risk for complicated grief. 3) Implement and evaluate three PLGT cohorts (NTotal = 40) in three long-term care facilities with family caregivers at-risk for complicated grief whose care recipient has a life expectancy of 6 months or less and resides in a long-term care facility.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: August 30, 2021
• Est. primary completion date: May 28, 2021
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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 the facility. Caregivers with ADRD residents nearing death will be temporally closer to their grief/preparedness experience permitting 3 month post death follow-up within the study timeline. Eligibility (stage 1). Potential family caregiver participants will be identified by facility leadership (Medical Director, Social Worker and Director of Nursing) by these inclusion criteria:

1. resident ADRD diagnosis,

2. life expectancy, "Would you be surprised if this resident died in the next 6 months?" and

3. caregiver proximity to facility permitting participation. Potential participants will receive an invitation phone call from the ResearchAssistant (RA). Eligibility (stage 2). Interested individuals will be invited to a pre-screening interview with the RA in person at the facility. Those who meet the final inclusion criteria,

4. minimum score of 4 on p-BGQ, and

5. positive scores on 4 of 9 risk factors will qualify

Exclusion Criteria:

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

Related Conditions & MeSH terms

• Dementia
• Grief

Intervention

Behavioral:
• Pre-loss group therapy
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.

Locations

Country	Name	City	State
United States	Silverado Care Facility	Salt Lake City	Utah
United States	St. Joseph Villa	Salt Lake City	Utah
United States	William E. Christoffersen Veterans Home	Salt Lake City	Utah

Sponsors (2)

Lead Sponsor	Collaborator
University of Utah	Alzheimer's Association

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Meaning Making	Change in meaning making as measured by Grief and Meaning Reconstruction Inventory, (Gillies, et al., 2015; GMRI)	3 months post death of care recipient
Secondary	Preparedness	Change in perceived preparedness for death of care recipient as measured by Preparedness question; "How prepared are you/were you for the death of your (spouse/parent)?" (Herbert, Dang & Schulz, 2006).	3 months post death of care recipient