Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000491369
Ethics application status
Approved
Date submitted
12/08/2008
Date registered
30/09/2008
Date last updated
30/09/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
Expressive Writing: An investigation of whether and how writing about stressful experiences can be used to enhance psychological and physical well-being in recently treated adult cancer patients and healthy community volunteers
Scientific title
Expressive Writing: An investigation of whether and how writing about stressful experiences can be used to enhance psychological and physical well-being. Samples: healthy community volunteers and recently treated adult cancer patients. Primary outcomes: stress and psychosomatic symptoms.
Secondary ID [1] 725 0
Nil
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Healthy participants (preventative: stress including PTSD symptoms) 3543 0
Adult cancer patients 3743 0
Condition category
Condition code
Cancer 3699 3699 0 0
Other cancer types
Mental Health 3700 3700 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
There are 2 separate arms to this study:
1. Healthy adult participants randomized to the Expressive Writing (EW) [or to the Neutral Writing/ Control condition]. Healthy participants randomized to the EW condition are asked to write about a nominated personal stressful life experience on 4 consecutive weekly sessions for 20 mins per session.
2. Recently treated adult cancer patients. Similarly there are 2 writing conditions for the cancer arm of this trial. Participants randomized to the EW condition are asked to write about their cancer experience over 4 consecutive weekly sessions for 20 mins per session.
Intervention code [1] 3255 0
Treatment: Other
Comparator / control treatment
1. Healthy adult participants
2. Recently adult treated cancer patients.
For both sub-samples, participants randomized to the Control conditions are asked to write about neutral (non-emotive events) over 4 consecutive weekly sessions for 20 mins per session.
Control group
Active

Outcomes
Primary outcome [1] 4602 0
PTSD symptoms & stress symptoms measured by (1) Impacte of Events Scale-Revised; and (2) Symptom Checklist (SCL-R90) - stress and anxiety subsubscales
Timepoint [1] 4602 0
Baseline/ Pre-writing intervention; 1-month, 6-month, and 12-months follow-up.
Primary outcome [2] 4603 0
Somatic symptoms assessed by Pennebaker Inventory of Limbic Languidness (PILL) scale
Timepoint [2] 4603 0
Baseline/ Pre-writing intervention; peri-intervention; 1-month, 6-month, and 12-months follow-up.
Primary outcome [3] 4604 0
Negative Cognitive Beliefs assessed by the Posttraumatic Cognitions Inventory (PTCI)
Timepoint [3] 4604 0
Baseline/ Pre-writing intervention; 1-month, 6-month, and 12-months follow-up.
Secondary outcome [1] 7767 0
Depressive symptoms assessed by the Symptom Checklist (SCL-R90) - depression subsubscale
Timepoint [1] 7767 0
Baseline/ Pre-writing intervention; 1-month, 6-month, and 12-months follow-up.

Eligibility
Key inclusion criteria
1. Healthy adult participants:
(i) able to speak, read and write basic English;
(ii) minimum 18 years or older

2. Cancer sub-sample
(i) minimum 18 years or older
(ii) completed all medical treatment for their cancer (any type of cancer)
(iii) able to speak, read and write basic English
(iv) medically fit to respond to assessment and intervention protocols
Minimum age
18 Years
Maximum age
85 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Both sub-samples (healthy volunteers and cancer patients):
i) no current suicidal ideation
ii) absence of severe levels of psychopathology (Axis I or II disorders)

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)
Random number table (allocation not concealed)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using randomisation table and stratified by gender
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
1/08/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
200
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)

Funding & Sponsors
Funding source category [1] 3724 0
Government body
Name [1] 3724 0
Australian Research Council
Country [1] 3724 0
Australia
Primary sponsor type
University
Name
Macquarie University
Address
Macquarie University
Department of Psychology
Building C3A - Room717
(Entrance via Waterloo Road)
Ryde, NSW 2109
Country
Australia
Secondary sponsor category [1] 3342 0
None
Name [1] 3342 0
Address [1] 3342 0
Country [1] 3342 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5776 0
Macquarie University - Human Ethics Committee
Ethics committee address [1] 5776 0
Ethics committee country [1] 5776 0
Australia
Date submitted for ethics approval [1] 5776 0
Approval date [1] 5776 0
24/04/2006
Ethics approval number [1] 5776 0
HE25NOV2005-RO4371 (Healthy subsample)/ HE28APR2006-RO4644 (Cancer sub-sample conjoint approval with RPA see Ethics Committee 2)
Ethics committee name [2] 5777 0
Sydney South West Area Health Service (RPA Zone)
Ethics committee address [2] 5777 0
Ethics committee country [2] 5777 0
Australia
Date submitted for ethics approval [2] 5777 0
Approval date [2] 5777 0
30/06/2006
Ethics approval number [2] 5777 0
X06-0092 (for recruitment of cancer patients)

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

Contacts
Principal investigator
Name 28832 0
Address 28832 0
Country 28832 0
Phone 28832 0
Fax 28832 0
Email 28832 0
Contact person for public queries
Name 11989 0
Dr Maria Kangas
Address 11989 0
Department of Psychology
Centre for Emotional Health
Macquarie University
Building C3A - Room 717
(Entrance via Waterloo Road)
Ryde, NSW 2109
Country 11989 0
Australia
Phone 11989 0
(02) 9850 8599
Fax 11989 0
(02) 9850 8062
Email 11989 0
[email protected]
Contact person for scientific queries
Name 2917 0
Dr Maria Kangas
Address 2917 0
Department of Psychology
Centre for Emotional Health
Macquarie University
Building C3A - Room 717
(Entrance via Waterloo Road)
Ryde, NSW 2109
Country 2917 0
Australia
Phone 2917 0
(02) 9850 8599
Fax 2917 0
(02) 9850 8062
Email 2917 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.