Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12611000687998
Ethics application status
Approved
Date submitted
4/07/2011
Date registered
7/07/2011
Date last updated
7/07/2011
Type of registration
Retrospectively registered

Titles & IDs
Public title
Can writing reduce stress and improve health in older people?
Scientific title
In healthy older adults, can a brief expressive writing intervention reduce psychological stress and improve the rate of healing of a 4mm dermal punch biopsy wound on the inner, upper arm?
Secondary ID [1] 262443 0
Nil
Universal Trial Number (UTN)
U1111-1122-3945
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
psychological stress 268137 0
dermal wound healing 268138 0
Condition category
Condition code
Mental Health 268279 268279 0 0
Studies of normal psychology, cognitive function and behaviour
Skin 268280 268280 0 0
Normal skin development and function
Inflammatory and Immune System 268281 268281 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Expressive Writing Intervention (3 days of consecutive writing, 20 minutes of writing on each day).

WRITING INTERVENTION:
Intervention: Expressive Writing Group - Participants in this group will be asked to write about their most traumatic/upsetting experience in their life. Specifically, to disclose their deepest thoughts, feelings, and emotions about the event, ideally not previously shared with others.

Control: Time Management Group - Participants allocated to this group will be asked to write descriptively about time management (i.e. what they will be doing the next day). This group will be asked not to mention emotions, opinions, or beliefs.

Participants will be randomly allocated to either the intervention group or the control group by the RA. Each participant will meet with a research assistant (RA) one-on-one, during which the RA will explain the writing instructions (either the Expressive Writing or Time Management instructions), and provide the participant with an exercise book and pen.

The RA will telephone each participant the next day to remind the participant to complete their writing task, and to answer any questions they may have. The RA follows up with each participant after a few more days to ensure the three writing tasks have been completed.

The writing tasks are unsupervised - they are completed by the participant at a time and place most convenient to them; however, we request the participant finds a quiet place to do the writing, so they will not be disturbed during the 20 minutes.

The exercise books are collected approximately two weeks after they have finished the writing task. The writing is not shared with other participants. Only the researchers and RA have access the essays for analysis.

The researcher collects the exercise books from the participants, and gives these books to the RA. The RA then re-assigns a new ID code to each exercise book (and 'blacks out' the former ID code), and returns the book to the researcher, in order for the researcher to transcribe the essays electronically yet remain blinded to group allocation. (i.e. ID code 2wf will be reassigned a new code by the RA (i.e. 3mp) to prevent the researcher from inadvertently associating the former ID code (2wf) with the essay).

WOUND HEALING:
Punch Biopsy: The punch biopsy occurs approximately two weeks after the first writing session. The punch biopsy procedure is performed by a licensed general practitioner (GP). The punch is 4mm diameter, and is created on the upper, inner non-dominant arm, under local anesthesia. Once the wound is created, a photo of the wound is taken (baseline). The wound is then covered with DuoDerm (a hydrocolloid dressing) and a waterproof bandage for 7 days. After 7 days, the wound is gently cleaned with sterile saline, photographed, and redressed. This same procedure is carried out every 3-4 days until the wound is healed. Healed is defined as full re-epithelialization of the wound, as determined by the study dermatologist, based on the wound photographs taken at each time point.

BLOOD DRAWS:
One blood sample is taken the day of the writing instruction administration, and a second blood sample is taken the day of the punch biopsy.
Intervention code [1] 266817 0
Treatment: Other
Comparator / control treatment
Control: Time Management Group - Participants allocated to this group will be asked to write descriptively about time management (i.e. what they will be doing the next day). This group will be asked not to mention emotions, opinions, or beliefs. They will be asked to write for 20 minutes a day, over three consecutive days.
Control group
Active

Outcomes
Primary outcome [1] 269006 0
(1) The time needed for a 4mm skin biopsy punch wound (inner, upper arm) to heal between individuals in the Expressive Writing group and individuals in the Time Management group (active control)

We define 'healed' as full re-epithelialization of the wound, as determined by the study dermatologist, based on bi-weekly wound photographs.
Timepoint [1] 269006 0
Wounds photographed at Days 0, 7, 10/11, 14, 17/18, 21, 24/25, 28, etc. until 'healed'.
Secondary outcome [1] 276788 0
(1) Pro-inflammatory cytokine concentrations (e.g. IL-1beta, IL-6, TNF-alpha) in lipopolysaccharide-stimulated blood samples (repeated measure; between-groups comparison).
Timepoint [1] 276788 0
Blood collected pre-writing intervention (baseline) and again at post-writing intervention (approximately 2 weeks later)
Secondary outcome [2] 276789 0
(2) Activation of immune cells (e.g. macrophage) and expression of Langerhans cells (antigen presenting dendritic cells) in the skin biopsy tissue.
Timepoint [2] 276789 0
Tissue collected at time of punch biopsy procedure.
Secondary outcome [3] 276790 0
(3) Changes in perceived psychological stress (repeated measure; between-groups comparison)

Perceived stress will be assessed using the 10-item Perceived Stress Scale (paper-and-pen self-report questionnaire)
Timepoint [3] 276790 0
Perceived Stress will be assessed at baseline (pre-writing intervention), at 2 weeks, and at 8 weeks.
Secondary outcome [4] 276791 0
(4) Changes in the frequency of causal/insightful words included in essays over the course of the three writing sessions (a measure of cognitive restructuring) (repeated measure; between-groups comparison)


Note: hand-written essays will be electronically transcribed and analyzed using the LIWC (Linguistic Inquiry and Word Counts) software package.
Timepoint [4] 276791 0
Essays from Day 1, 2, and 3.
Secondary outcome [5] 276792 0
(5) Number of doctor's visits in a 12 week period (repeated measure; between-groups comparison).
Timepoint [5] 276792 0
Participants are asked at baseline for the pre-intervention time point, and telephoned at 12 weeks post punch biopsy procedure for the post-intervention time point.
Secondary outcome [6] 276802 0
(6) Changes in mood state (repeated measure; between-groups comparison)

Mood state will be assessed using the 15-item Geriatric Depression Scale (paper-and-pen self-report questionnaire)
Timepoint [6] 276802 0
Mood will be assessed at baseline (pre-writing intervention), at 2 weeks, and at 8 weeks.

Eligibility
Key inclusion criteria
healthy older adults (>65 years) living in 'independent living' accommodations at retirement villages in Auckland area
Minimum age
65 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
(1) unable to hand-write or type (e.g. on a computer or typewriter) in English
(2) Cognitive impairments that prevent making informed consent
(3) currently have clinical depression
(4) skin complaints (e.g. eczema, psoriasis, keloid scarring)
(5) smoker
(6) allergic to lignocaine

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Study flyers are distributed to the letterboxes of 'independent living' residents at retirement villages (providing management consent). When permitted, a brief (20 minute) presentation about the study is provided to independent living residents at the retirement villages.
Interested residents can sign up to be volunteers after the presentation, or they can call the researchers to volunteer.

Allocation concealment procedures:

All interested individuals undergo a 'pre-study' interview screen over the telephone, to ensure eligibility. This 'pre-study' interview is carried out by the researcher.


If eligible to participate, the researcher would then assign this individual a 'participant ID' code. This ID code is
a 3 digit alpha-numeric code (i.e. 2wf).


Next, the researcher would give the 'participant ID' code to a RA, and the RA would assign this ID code to either the Expressive Writing or Time Management Group (based on a computer generated randomiszation table).

The RA (NOT the researcher) administers the writing instructions (i.e. Expressive Writing or Time Management instructions) in order to keep the researcher blinded to group allocation. The RA also requests that the participant does not share details about their writing instructions to others (i.e. other participants and/or residents in the retirement village).

The RA also follows up with each participant over the days following the writing intervention to answer any questions they have about the writing task, to keep the other researchers blinded to group allocation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software (i.e. "research randomizer" http://www.randomizer.org/form.htm)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
23/03/2011
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
70
Accrual to date
Final
Recruitment outside Australia
Country [1] 3640 0
New Zealand
State/province [1] 3640 0
Auckland

Funding & Sponsors
Funding source category [1] 267289 0
University
Name [1] 267289 0
The University of Auckland Faculty Research Development Fund
Country [1] 267289 0
New Zealand
Funding source category [2] 267290 0
Charities/Societies/Foundations
Name [2] 267290 0
Maurice and Phyllis Paykel Trust
Country [2] 267290 0
New Zealand
Funding source category [3] 267291 0
University
Name [3] 267291 0
Performance Based Research Fund - School of Medicine - The University of Auckland
Country [3] 267291 0
New Zealand
Primary sponsor type
University
Name
The University of Auckland
Address
The University of Auckland
Private Bag 92019 Auckland
Mail Centre Auckland
1142 New Zealand
Country
New Zealand
Secondary sponsor category [1] 266350 0
None
Name [1] 266350 0
Address [1] 266350 0
Country [1] 266350 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 269283 0
The University of Auckland Human Participants Ethics Committee (UAHPEC)
Ethics committee address [1] 269283 0
Ethics committee country [1] 269283 0
New Zealand
Date submitted for ethics approval [1] 269283 0
Approval date [1] 269283 0
10/12/2010
Ethics approval number [1] 269283 0
2010/532

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 32773 0
Address 32773 0
Country 32773 0
Phone 32773 0
Fax 32773 0
Email 32773 0
Contact person for public queries
Name 16020 0
Elizabeth Broadbent
Address 16020 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Auckland, New Zealand
Country 16020 0
New Zealand
Phone 16020 0
64 9 373 7599 ext 86756
Fax 16020 0
Email 16020 0
[email protected]
Contact person for scientific queries
Name 6948 0
Elizabeth Broadbent
Address 6948 0
Department of Psychological Medicine
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre 1142
Auckland, New Zealand
Country 6948 0
New Zealand
Phone 6948 0
64 9 373 7599 ext 86756
Fax 6948 0
Email 6948 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.