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Trial registered on ANZCTR
Registration number
ACTRN12623000474651
Ethics application status
Approved
Date submitted
9/04/2023
Date registered
9/05/2023
Date last updated
13/07/2023
Date data sharing statement initially provided
9/05/2023
Type of registration
Prospectively registered
Titles & IDs
Public title
Can walking enhance the effects of written emotional disclosure?
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Scientific title
Can walking enhance the effects of written emotional disclosure on cognitive processing and mood in adults aged 18-50 years
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Secondary ID [1]
309333
0
Nil known
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Stress
329536
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Condition category
Condition code
Mental Health
326470
326470
0
0
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Studies of normal psychology, cognitive function and behaviour
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Participants will be randomised to one of three conditions, sitting (control treatment), walking on a treadmill (intervention treatment), and walking outside in an urban environment (intervention treatment). The study will be conducted face to face at the University of Auckland medical campus and will involve answering some questionnaires (demographics and mood) and then following a written emotional disclosure protocol (Pennebaker, 1997) with three writing sessions on the same day. Participants will be allocated to one of the three randomised conditions and perform the allocated behaviour (sitting control condition or walking on treadmill intervention condition, or walking outside intervention condition) during a 15 minute break between the first and second, and second and third writing sessions. There will be three writing sessions of 20 minutes each, which will be completed on a computer and will be based on standard written emotional disclosure instructions. Standard written emotional disclosure involves writing about one’s traumatic and upsetting experiences, delving into one's deepest thoughts, feelings, and emotions about the event, ideally not previously shared with others. It is typically performed for 20 minutes a day on three consecutive days, although it can be performed with all three sessions on one day (Symth et al., 2008), which will be done in this experiment. The 15 minute sitting or walking interventions will take place in the breaks between writing. Participants will be supervised by researchers to ensure that they follow instructions and, particularly for the urban walking condition, that they do not stop and talk to anyone or get lost.
Participants will then be asked to complete another mood questionnaire after the final writing session administered on the computer using Qualitrics. They will be contacted by email after a 4 week follow up period to complete a final mood questionnaire remotely over Qualtrics.
To support the blinding of condition, all participants will be asked to walk briefly on a treadmill right at the end of the procedure after the mood questionnaire and writing has been completed for the day. In this way, all participants will think they are in the walking group and this will reduce the risk of placebo effects.
All participants will then be asked if they felt the walking was beneficial. Participants will be given a $30 voucher for taking part.
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Intervention code [1]
325771
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Behaviour
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Comparator / control treatment
The control for the study is the sitting condition, against which the two walking conditions will be compared
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Control group
Active
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Outcomes
Primary outcome [1]
334315
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Change in the use of cognitive processing words (words associated with causation and insight) over the three writing sessions measured with Linguistic Analysis and Word Count (LIWC)
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Assessment method [1]
334315
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Timepoint [1]
334315
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writing sessions are completed sequentially on the day of the experiment.
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Secondary outcome [1]
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changes in mood (measured using the Profile of Mood States, POMS)
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Assessment method [1]
420232
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Timepoint [1]
420232
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POMs will be sampled at baseline, following the third writing exercise and again after a 4 week follow up period.
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Eligibility
Key inclusion criteria
Participants must be:
- 18 - 50 years old
- have experienced a stressful or emotionally challenging event in their lives
- be fluent in English (important for LIWC analysis)
- be able to type on a regular computer
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Minimum age
18
Years
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Maximum age
50
Years
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Sex
Both males and females
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Can healthy volunteers participate?
No
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Key exclusion criteria
Have a walking disability or be unable to walk easily.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation will be concealed and the experimenter will be blind to the allocation until they open the envelope. This will be achieved by using sealed opaque envelopes which will be opened by the experimenter at the time of randomisation (after participants complete the baseline questionnaire). The envelopes will be prepared by someone outside the research group.
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation will be done using the service available on www.random.org. There will be no stratification.
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Masking / blinding
Blinded (masking used)
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Who is / are masked / blinded?
The people receiving the treatment/s
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
Efficacy
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Statistical methods / analysis
We carried out a power analysis using G*Power software for a fixed effects, omnibus, one-way ANOVA, using power level of .80 and Type I error probability of alpha = .05. We based the analysis on an expected effect of d = .70 (f = 0.35) based on the first study in a paper on the effects of walking on divergent thinking (Oppezzo & Schwartz, 2014). These parameters guide us to recruit a sample of 84 people, 28 in each group. We estimate a low attrition rate because only a single visit to the lab will be required and follow-up can be done online. To allow for attrition we will recruit 90 people (6 extra people)..
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Recruitment
Recruitment status
Recruiting
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Date of first participant enrolment
Anticipated
6/06/2023
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Actual
9/06/2023
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Date of last participant enrolment
Anticipated
29/10/2023
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Actual
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Date of last data collection
Anticipated
3/11/2023
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Actual
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Sample size
Target
90
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Accrual to date
9
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Final
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Recruitment outside Australia
Country [1]
25361
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New Zealand
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State/province [1]
25361
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Auckland
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Funding & Sponsors
Funding source category [1]
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University
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Name [1]
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University of Auckland
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Address [1]
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Department of Psychological Medicine
The University of Auckland
Level 3
22-30 Park Ave, Grafton
Auckland 1023,
New Zealand
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Country [1]
313534
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New Zealand
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Primary sponsor type
University
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Name
University of Auckland
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Address
Department of Psychological Medicine
The University of Auckland
Level 3
22-30 Park Ave, Grafton
Auckland 1023,
New Zealand
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Country
New Zealand
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Secondary sponsor category [1]
315314
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None
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Name [1]
315314
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Address [1]
315314
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Country [1]
315314
0
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Ethics approval
Ethics application status
Approved
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Ethics committee name [1]
312716
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Auckland Health Research Ethics Committee
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Ethics committee address [1]
312716
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Auckland Health Research Ethics Committee
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
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Ethics committee country [1]
312716
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New Zealand
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Date submitted for ethics approval [1]
312716
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13/03/2023
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Approval date [1]
312716
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17/03/2023
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Ethics approval number [1]
312716
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AH25540
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Summary
Brief summary
The study aims to determine if adding walking to the written emotional disclosure paradigm can increase cognitive processing, leading to greater positive effects on mood. The primary hypothesis is that walking participants will use more cognitive processing words than sitting participants in the last two writing sessions, as measured by the LIWC program. The secondary hypothesis is that walking outside will have greater effects than walking on a treadmill. The tertiary hypothesis is that all walking subjects will experience greater positive changes in mood, measured by the POMS subscales, compared to the control group. The POMS will be administered at baseline, the end of the in-person session, and at the 4-week follow-up.
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Trial website
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
125654
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Prof Elizabeth Broadbent
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Address
125654
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Faculty of Medical and Health Science
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
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Country
125654
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New Zealand
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Phone
125654
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+64 9 3737599
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Fax
125654
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Email
125654
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[email protected]
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Contact person for public queries
Name
125655
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Prof Elizabeth Broadbent
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Address
125655
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Faculty of Medical and Health Science
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
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Country
125655
0
New Zealand
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Phone
125655
0
+64 9 3737599
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Fax
125655
0
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Email
125655
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[email protected]
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Contact person for scientific queries
Name
125656
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Prof Elizabeth Broadbent
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Address
125656
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Faculty of Medical and health Science
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
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Country
125656
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New Zealand
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Phone
125656
0
+64 9 3737599
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Fax
125656
0
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Email
125656
0
[email protected]
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Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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No/undecided IPD sharing reason/comment
An important consideration for any studies within New Zealand is the data sovereignty of tanagta whenua. This precludes the sharing of any data, including de-identified data, with anyone not located in New Zealand. For this reason, and because we cannot guarantee that data will not be re-shared outside New Zealand we cannot share any data.
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What supporting documents are/will be available?
No Supporting Document Provided
Doc. No.
Type
Citation
Link
Email
Other Details
Attachment
18796
Study protocol
[email protected]
18797
Statistical analysis plan
[email protected]
18798
Ethical approval
[email protected]
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.
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