NCT00303147

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

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
120

participants targeted

Target at P75+ for phase_1

Timeline
Completed

Started May 2003

Typical duration for phase_1

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2003

Completed
2.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 14, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 15, 2006

Completed
Last Updated

March 15, 2006

Status Verified

March 1, 2006

First QC Date

March 14, 2006

Last Update Submit

March 14, 2006

Conditions

Stress, PsychologicalAnxiety

Keywords

Expressive WritingWritten Emotional ExpressionCaregiver StressCognition

Outcome Measures

Primary Outcomes (6)

  • 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)

Interventions

Expressive WritingBEHAVIORAL

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Primary family caregiver for an older adult with dementia
  • Self-reported caregiver stress or burden
  • Fluency in written/spoken English

You may not qualify if:

  • non-family or non-primary caregiver
  • existing use of expressive writing / diary

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Toronto

Toronto, Ontario, M5S 1V6, Canada

Location

MeSH Terms

Conditions

Stress, PsychologicalAnxiety DisordersCaregiver Burden

Condition Hierarchy (Ancestors)

Behavioral SymptomsBehaviorMental Disorders

Study Officials

  • 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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 1
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 14, 2006

First Posted

March 15, 2006

Study Start

May 1, 2003

Study Completion

July 1, 2005

Last Updated

March 15, 2006

Record last verified: 2006-03

Locations

CA(1)