- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02672800
A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia
A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia: Adapting the "Finding Balance" Tool
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
The current research is part 3 of a multi-phase project, whose purpose was to examine the experience of bereavement for spousal caregivers to persons with dementia. Based on spouses' shared experiences and the input of experts in the field (i.e. bereavement/dementia researchers, health care providers), an existing writing intervention called the Finding Balance tool was adapted from the context of cancer bereavement to that of dementia.
The purpose of this third phase is to test this adapted writing intervention (Reclaiming Yourself) with bereaved spouses of persons with dementia. Participants will be randomly assigned into one of two groups: treatment (who will receive the tool); and control (who will not be offered the tool until a later stage). The feasibility and acceptability of the intervention will be assessed, as well as the degree to which it facilitated participants' bereavement, ability to find balance, and psychological health.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Saskatchewan
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Saskatoon, Saskatchewan, Canada, S7J3Z1
- University of Saskatchewan
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- bereaved for three months or longer
- were a caregiver for their spouse with advanced dementia
- English speaking
- willing and able to share their bereavement experience
Exclusion Criteria:
- those with other than a spousal relationship to the person with dementia
- spousal caregivers of persons with another terminal disease
- those bereaved less than 3 months
- those unable to provide consent
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
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No Intervention: Control
|
|
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Experimental: Writing intervention
|
This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Inventory of Daily Widowed Life (IDWL)- change at 1 and 2 months post-intervention
Time Frame: The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention
|
Measure of finding balance in bereavement
|
The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention
|
|
Center for Epidemiologic Studies Depression Scale- Revised (CESD-R)- change at 1 and 2 months post-intervention
Time Frame: The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention
|
Measure of depressive symptoms
|
The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention
|
|
Texas Revised Inventory of Grief, Present Feelings- change at 1 and 2 months post-intervention
Time Frame: The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention
|
Measure of grief
|
The measure will be administered pre-intervention, 1 month following the introduction of the intervention, and 2 months following the introduction of the intervention
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Semi-structured qualitative evaluation interviews
Time Frame: Post intervention (after 1 month)
|
Measure of the feasibility and acceptability of the intervention
|
Post intervention (after 1 month)
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Shelley Peacock, RN, PhD, University of Saskatchewan
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 15-313
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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