- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00303147
Cognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress
Study Overview
Status
Conditions
Intervention / Treatment
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).
Study Type
Enrollment
Phase
- Phase 1
Contacts and Locations
Study Locations
-
-
Ontario
-
Toronto, Ontario, Canada, M5S 1V6
- University of Toronto
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
|---|
|
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)
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Corey S Mackenzie, Ph.D., University of Toronto
- Principal Investigator: Lynn Hasher, Ph.D., University of Toronto
- Principal Investigator: David Goldstein, Ph.D., University of Toronto
Study record dates
Study Major Dates
Study Start
Study Completion
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 11438
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.