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A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia

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ClinicalTrials.gov Identifier: NCT02672800
Recruitment Status : Completed
First Posted : February 3, 2016
Last Update Posted : May 4, 2018
Sponsor:
Information provided by (Responsible Party):
Shelley Peacock, University of Saskatchewan

Study Description
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Brief Summary:
The purpose of this study is to evaluate the feasibility and acceptability of a writing intervention (Reclaiming Yourself), intended to facilitate bereavement for spousal caregivers whose partners died with dementia.

Condition or disease Intervention/treatment Phase
Dementia Bereavement Behavioral: the Reclaiming Yourself tool Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia: Adapting the "Finding Balance" Tool
Study Start Date : March 2016
Actual Primary Completion Date : December 2017
Actual Study Completion Date : March 2018

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Writing intervention Behavioral: the Reclaiming Yourself tool
This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia
No Intervention: Control


Outcome Measures
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Primary Outcome Measures :
  1. 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

  2. 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

  3. 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


Secondary Outcome Measures :
  1. Semi-structured qualitative evaluation interviews [ Time Frame: Post intervention (after 1 month) ]
    Measure of the feasibility and acceptability of the intervention


Eligibility Criteria
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Ages Eligible for Study:   60 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations
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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): NCT02672800


Locations
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Canada, Saskatchewan
University of Saskatchewan
Saskatoon, Saskatchewan, Canada, S7J3Z1
Sponsors and Collaborators
University of Saskatchewan
Investigators
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Principal Investigator: Shelley Peacock, RN, PhD University of Saskatchewan
More Information
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Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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Responsible Party: Shelley Peacock, Assistant Professor, College of Nursing, University of Saskatchewan
ClinicalTrials.gov Identifier: NCT02672800    
Other Study ID Numbers: 15-313
First Posted: February 3, 2016    Key Record Dates
Last Update Posted: May 4, 2018
Last Verified: May 2018
Additional relevant MeSH terms:
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Dementia
Brain Diseases
Central Nervous System Diseases
 Nervous System Diseases
Neurocognitive Disorders
Mental Disorders