A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia

May 1, 2018 updated by: Shelley Peacock, University of Saskatchewan

A Psychosocial Intervention for Bereaved Spousal Caregivers of Persons With Dementia: Adapting the "Finding Balance" Tool

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.

Study Overview

Status

Completed

Conditions

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

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Saskatchewan
      • Saskatoon, Saskatchewan, Canada, S7J3Z1
        • University of Saskatchewan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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
No Intervention: Control
Experimental: Writing intervention
This tool is a behavioural writing intervention, intended to facilitate bereavement for spousal caregivers of persons with dementia

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

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Shelley Peacock, RN, PhD, University of Saskatchewan

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2016

Primary Completion (Actual)

December 1, 2017

Study Completion (Actual)

March 1, 2018

Study Registration Dates

First Submitted

January 28, 2016

First Submitted That Met QC Criteria

February 1, 2016

First Posted (Estimate)

February 3, 2016

Study Record Updates

Last Update Posted (Actual)

May 4, 2018

Last Update Submitted That Met QC Criteria

May 1, 2018

Last Verified

May 1, 2018

More Information

Terms related to this study

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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