Stress, PsychologicalPhase 1NCT00303147
Cognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress
A Phase 1 study testing Expressive Writing in people with Stress, Psychological and Anxiety, run by University of Toronto at 1 site in Canada.
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 Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Stress, Psychological, Anxiety
- What is being tested?
- Expressive Writing
- Type of treatment
- Lifestyle or therapy programme
- How many people
- 120 participants
- Where
- 1 siteCanada
- Study dates
- May 2003to Jul 2005
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Primary family caregiver for an older adult with dementia
- Self-reported caregiver stress or burden
- Fluency in written/spoken English
Who cannot join
- non-family or non-primary caregiver
- existing use of expressive writing / diary
Trial locations and contacts
1 site in 1 country.
About this study
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
Read the 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).
- Conditions
- Stress, Psychological, Anxiety
- Being tested
- Expressive Writing
- Keywords
- Expressive Writing, Written Emotional Expression, Caregiver Stress, Cognition
- Medical subject headings
- Stress, Psychological, Anxiety Disorders, Caregiver Burden
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Expressive WritingBehavioural
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2006 (estimated)
- Study startMay 2003
- Study completionJul 2005
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stress, PsychologicalStudies of the same condition, open and under way.
- More trials run by University of TorontoThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants
Sponsor and investigators
- Lead sponsor
- University of Toronto
- Sponsor type
- University, hospital or other
- Collaborators
- Baycrest Centre for Geriatric Care
- Investigators
- Corey S Mackenzie, Ph.D., Principal investigator, University of TorontoLynn Hasher, Ph.D., Principal investigator, University of TorontoDavid Goldstein, Ph.D., Principal investigator, University of Toronto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00303147
- Sponsor's protocol ID
- 11438
- Status last verified
- Mar 2006
- First submitted
- 14 Mar 2006
- Last updated
- 15 Mar 2006
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Mar 2006. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Cognitive and Health Benefits of Expressive Writing for Family Caregivers Under Stress
- ClinicalTrials.gov ID
- NCT00303147
- Acronym / sponsor ID
- 11438
- Conditions
- Stress, Psychological, Anxiety
- Keywords
- Expressive Writing, Written Emotional Expression, Caregiver Stress, Cognition
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants
- Lead sponsor
- University of TorontoUniversity, hospital or other
- Collaborators
- Baycrest Centre for Geriatric Care
- Study start
- May 2003
- Study completion
- Jul 2005
- First posted
- 15 Mar 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Primary family caregiver for an older adult with dementia
- Self-reported caregiver stress or burden
- Fluency in written/spoken English
Key exclusion criteria (2 listed)
- non-family or non-primary caregiver
- existing use of expressive writing / diary
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Expressive Writing | Behavioural | – |
Primary outcome
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)
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Mar 2006.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Corey S Mackenzie, Ph.D. principal investigator
University of Toronto
Lynn Hasher, Ph.D. principal investigator
University of Toronto
David Goldstein, Ph.D. principal investigator
University of Toronto
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Expressive Writing in people with Stress, Psychological and Anxiety, run by University of Toronto at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 15 Mar 2006. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General Health Questionnaire. The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Mar 2006.