Cognitive and Health Benefits of Expressive Writing for F... | NCT00303147

Studies
Cognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress

NCT00303147

Sponsor

University of Toronto

Status

Unknown status

Last Update Posted

Mar 15, 2006Estimated

Enrollment

120

Phase

Phase 1

Conditions

Stress, Psychological
Anxiety

Interventions

Expressive Writing

Countries

Canada

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2006

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

May 2003

Primary Completion Date

Not provided

Completion Date

Jul 2005

First Submitted Date

Mar 14, 2006

First Submission Date that Met QC Criteria

Mar 14, 2006

First Posted Date

Mar 15, 2006Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 14, 2006

Last Update Posted Date

Mar 15, 2006Estimated

Name	Class
Baycrest Centre for Geriatric Care	OTHER

Description Module

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).

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

120

Name	Type	Description	Arm Group Labels	Other Names
Expressive Writing	Behavioral

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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 Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
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

Locations

Facility	Status	City	State	ZIP	Country	Contacts
University of Toronto		Toronto	Ontario	M5S 1V6	Canada

Condition Browse Module

MeSH Terms

ID	Term
D013315	Stress, Psychological
D001008	Anxiety Disorders
D000084802	Caregiver Burden

Ancestor Terms

ID	Term
D001526	Behavioral Symptoms
D001519	Behavior
D001523	Mental Disorders

Browse Leaves

Not provided

Browse Branches

Not provided