Group Therapy For Dementia Caregivers At Risk For Complicated Grief (PLGT)

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.

Study Overview

• Status: Completed
• Conditions: Grief
• Intervention / Treatment: Behavioral: Pre-loss group therapy

Detailed 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.

• Study Type: Observational
• Enrollment (Actual): 80

Contacts and Locations

Study Locations

• United States
  • Utah
    • Salt Lake City, Utah, United States, 84115
      • St. Joseph Villa
    • Salt Lake City, Utah, United States, 84117
      • Silverado Care Facility
    • Salt Lake City, Utah, United States, 84148
      • William E. Christoffersen Veterans Home

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-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

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Ecologic or Community
• Time Perspectives: Prospective

Number of groups / cohorts

3

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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; 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 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; 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 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: University of Utah
• Collaborators: Alzheimer's Association

Study record dates

Study Major Dates

• Study Start (Actual): March 1, 2018
• Primary Completion (Actual): May 28, 2021
• Study Completion (Actual): August 30, 2021

Study Registration Dates

• First Submitted: May 26, 2017
• First Submitted That Met QC Criteria: June 5, 2017
• First Posted (Actual): June 6, 2017

Study Record Updates

• Last Update Posted (Actual): November 23, 2021
• Last Update Submitted That Met QC Criteria: November 22, 2021
• Last Verified: November 1, 2021

More Information

Terms related to this study

• Keywords: dementia; caregivers; grief; long-term care; psychotherapy group
• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Dementia
• Other Study ID Numbers: AARG-17-503706

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided
• IPD Plan Description: Research protocol is registered in Open Science Framework. Individual de-identified participant data available only through direct request to PI.

Study Data/Documents

1. Study Protocol
   Information identifier: dtp38
   Information comments: Open Science Framework. we are registered

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No