GriefPLGTNCT03177772
Group Therapy For Dementia Caregivers At Risk For Complicated Grief
An observational study of Grief, run by University of Utah at 3 sites in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Grief
- What is being tested?
- Pre-loss group therapy
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 80 participants
- Where
- 3 sitesUnited States
- Study dates
- 1 Mar 2018to 30 Aug 2021
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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:
- resident ADRD diagnosis,
- life expectancy, "Would you be surprised if this resident died in the next 6 months?" and
- 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,
- minimum score of 4 on p-BGQ, and
- positive scores on 4 of 9 risk factors will qualify
Who cannot join
- Active suicidality (likely hospitalization) will exclude interested individuals from participating
Trial locations and contacts
3 sites in 1 country.
United States3 sites
St. Joseph Villa
Salt Lake City, Utah, 84115
Silverado Care Facility
Salt Lake City, Utah, 84117
William E. Christoffersen Veterans Home
Salt Lake City, Utah, 84148
About this study
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.
Read the 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.
- Conditions
- Grief
- Being tested
- Pre-loss group therapy
- Keywords
- caregivers, grief, dementia, long-term care, psychotherapy group
- Medical subject headings
- Dementia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pre-loss group therapyBehavioural
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: Behavioral: Pre-loss group therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Grief
Change in pre-loss grief as measured by Inventory of Complicated Grief-revised (Prigerson, et al., 1995; ICG-r)
Measured: 3 months post death of care recipient
Secondary outcomes (2)
Meaning Making
Change in meaning making as measured by Grief and Meaning Reconstruction Inventory, (Gillies, et al., 2015; GMRI)
Measured: 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).
Measured: 3 months post death of care recipient
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2017
- Study start1 Mar 2018
- Primary completion28 May 2021
- Study completion30 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GriefStudies of the same condition, open and under way.
- More trials run by University of UtahThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Utah
- Sponsor type
- University, hospital or other
- Collaborators
- Alzheimer's Association
- Responsible party
- Principal investigator, Katherine Supiano, University of Utah
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03177772
- Sponsor's protocol ID
- AARG-17-503706
- Acronym
- PLGT
- Status last verified
- Nov 2021
- First submitted
- 26 May 2017
- Last updated
- 23 Nov 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: Research protocol is registered in Open Science Framework. Individual de-identified participant data available only through direct request to PI.
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Group Therapy For Dementia Caregivers At Risk For Complicated Grief
- ClinicalTrials.gov ID
- NCT03177772
- Acronym / sponsor ID
- PLGT / AARG-17-503706
- Conditions
- Grief
- Keywords
- caregivers, grief, dementia, long-term care, psychotherapy group
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- University of UtahUniversity, hospital or other
- Collaborators
- Alzheimer's Association
- Study start
- 1 Mar 2018 (actual)
- Primary completion
- 28 May 2021 (actual)
- Study completion
- 30 Aug 2021 (actual)
- First posted
- 6 Jun 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| LTC Facility 1 | – | Behavioral: Pre-loss group therapyPre-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. |
| LTC Facility 2 | – | Behavioral: Pre-loss group therapyPre-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. |
| LTC Facility 3 | – | Behavioral: Pre-loss group therapyPre-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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (6 listed)
- 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:
Key exclusion criteria (1 listed)
- Active suicidality (likely hospitalization) will exclude interested individuals from participating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Pre-loss group therapyThe 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. | Behavioural | LTC Facility 1, LTC Facility 2, LTC Facility 3 |
Primary outcome
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)
2 secondary outcomes
Meaning Making
Time frame: 3 months post death of care recipient
Preparedness
Time frame: 3 months post death of care recipient
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Nov 2021.
- Individual participant dataSharing planned: Undecided. Research protocol is registered in Open Science Framework. Individual de-identified participant data available only through direct request to PI.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Grief, run by University of Utah at 3 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Grief (time frame: 3 months post death of care recipient). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Nov 2021.