Back to resultsCognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress
Primary Purpose
Stress, Psychological, Anxiety
Status
Unknown status
Phase
Phase 1
Locations
Canada
Study Type
Interventional
Intervention
Expressive Writing
Sponsored by
About this trial
This is an interventional treatment trial for Stress, Psychological focused on measuring Expressive Writing, Written Emotional Expression, Caregiver Stress, Cognition
Eligibility Criteria
Inclusion Criteria: Primary family caregiver for an older adult with dementia Self-reported caregiver stress or burden Fluency in written/spoken English Exclusion Criteria: non-family or non-primary caregiver existing use of expressive writing / diary
Sites / Locations
- University of Toronto
Outcomes
Primary Outcome Measures
General Health Questionnaire
Impact of Events Scale
Zarit Burden Interview (short form)
California Verbal Learning Test
Ruff 2 & 7 Selective Attention Test
Wechsler Adult Intelligence Scale (WAIS)
Secondary Outcome Measures
Full Information
NCT ID
NCT00303147
First Posted
March 14, 2006
Last Updated
March 14, 2006
Sponsor
University of Toronto
Collaborators
Baycrest Centre for Geriatric Care
1. Study Identification
Unique Protocol Identification Number
NCT00303147
Brief Title
Cognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress
Study Type
Interventional
2. Study Status
Record Verification Date
March 2006
Overall Recruitment Status
Unknown status
Study Start Date
May 2003 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
July 2005 (undefined)
3. Sponsor/Collaborators
Name of the Sponsor
University of Toronto
Collaborators
Baycrest Centre for Geriatric Care
4. Oversight
5. Study Description
Brief Summary
The purpose of this study is to determine if expressive writing is an effective intervention for reducing stress, enhancing cognition, and improving quality of life for caregivers of older adults with dementia
Detailed Description
A significant and growing need exists to support caregivers of older adults with dementia, including methods of support that are easily implemented and targeted at caregivers who can not access multicomponent interventions. The current intervention examines the efficacy of one such approach: expressive writing (EW).
We are examining the efficacy of EW, in terms of its ability to reduce stress, enhance cognition, and improve well-being, by comparing it to two control conditions: objective writing about how caregivers spend their time (time management; TM) and objective writing about non-personal historical events (history writing; HW).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Stress, Psychological, Anxiety
Keywords
Expressive Writing, Written Emotional Expression, Caregiver Stress, Cognition
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
120 (false)
8. Arms, Groups, and Interventions
Intervention Type
Behavioral
Intervention Name(s)
Expressive Writing
Primary Outcome Measure Information:
Title
General Health Questionnaire
Title
Impact of Events Scale
Title
Zarit Burden Interview (short form)
Title
California Verbal Learning Test
Title
Ruff 2 & 7 Selective Attention Test
Title
Wechsler Adult Intelligence Scale (WAIS)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Primary family caregiver for an older adult with dementia
Self-reported caregiver stress or burden
Fluency in written/spoken English
Exclusion Criteria:
non-family or non-primary caregiver
existing use of expressive writing / diary
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Corey S Mackenzie, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Lynn Hasher, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
David Goldstein, Ph.D.
Organizational Affiliation
University of Toronto
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Toronto
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5S 1V6
Country
Canada
12. IPD Sharing Statement
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Cognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress
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