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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT00303147
Other study ID # 11438
Secondary ID
Status Active, not recruiting
Phase Phase 1
First received March 14, 2006
Last updated March 14, 2006
Start date May 2003
Est. completion date July 2005

Study information

Verified date March 2006
Source University of Toronto
Contact n/a
Is FDA regulated No
Health authority Canada: Ethics Review Committee
Study type Interventional

Clinical Trial 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


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).


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 120
Est. completion date July 2005
Est. primary completion date
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility 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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Behavioral:
Expressive Writing


Locations

Country Name City State
Canada University of Toronto Toronto Ontario

Sponsors (2)

Lead Sponsor Collaborator
University of Toronto Baycrest Centre for Geriatric Care

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary General Health Questionnaire
Primary Impact of Events Scale
Primary Zarit Burden Interview (short form)
Primary California Verbal Learning Test
Primary Ruff 2 & 7 Selective Attention Test
Primary Wechsler Adult Intelligence Scale (WAIS)
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