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Trial record 4 of 26 for:    Recruiting, Not yet recruiting, Available Studies | "Bereavement"

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

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ClinicalTrials.gov Identifier: NCT03177772
Recruitment Status : Recruiting
First Posted : June 6, 2017
Last Update Posted : April 17, 2018
Sponsor:
Collaborator:
Alzheimer's Association
Information provided by (Responsible Party):
Katherine Supiano, University of Utah

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.

Condition or disease Intervention/treatment
Grief 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
Estimated Enrollment : 80 participants
Observational Model: Ecologic or Community
Time Perspective: Prospective
Official Title: Group Therapy For Dementia Caregivers At Risk For Complicated Grief
Actual Study Start Date : March 1, 2018
Estimated Primary Completion Date : June 2020
Estimated Study Completion Date : August 2020

Resource links provided by the National Library of Medicine


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.




Primary Outcome Measures :
  1. Grief [ Time Frame: 3 months post death of care recipient ]
    Change in pre-loss grief as measured by Inventory of Complicated Grief-revised (Prigerson, et al., 1995; ICG-r)


Secondary Outcome Measures :
  1. Meaning Making [ Time Frame: 3 months post death of care recipient ]
    Change in meaning making as measured by Grief and Meaning Reconstruction Inventory, (Gillies, et al., 2015; GMRI)

  2. Preparedness [ Time Frame: 3 months post death of care recipient ]
    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).



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes 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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03177772


Contacts
Contact: Katherine Supiano, PhD 8015512322 katherine.supiano@hsc.utah.edu
Contact: Troy C Andersen, PhD 8015879648 troy.andersen@hsc.utah.edu

Locations
United States, Utah
Silverado Care Facility Recruiting
Salt Lake City, Utah, United States, 84117
Contact: Crystal Shelley, MSW    801-272-8000    sshelley@silverado.com   
Sponsors and Collaborators
University of Utah
Alzheimer's Association

Study Data/Documents: Study Protocol  This link exits the ClinicalTrials.gov site
Identifier: dtp38
Open Science Framework. we are at preregistration phase

Responsible Party: Katherine Supiano, Associate Professor, University of Utah
ClinicalTrials.gov Identifier: NCT03177772     History of Changes
Other Study ID Numbers: AARG-17-503706
First Posted: June 6, 2017    Key Record Dates
Last Update Posted: April 17, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Research protocol is registered in Open Science Framework. Individual de-identified participant data available only through direct request to PI.

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Katherine Supiano, University of Utah:
caregivers
grief
dementia
long-term care
psychotherapy group

Additional relevant MeSH terms:
Dementia
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurocognitive Disorders
Mental Disorders