Trial Review

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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?
Scientific title
Can walking enhance the effects of written emotional disclosure on cognitive processing and mood in adults aged 18-50 years
Secondary ID [1] 309333 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Stress 329536 0
Condition category
Condition code
Mental Health 326470 326470 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
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.
Intervention code [1] 325771 0
Behaviour
Comparator / control treatment
The control for the study is the sitting condition, against which the two walking conditions will be compared
Control group
Active

Outcomes
Primary outcome [1] 334315 0
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)
Timepoint [1] 334315 0
writing sessions are completed sequentially on the day of the experiment.
Secondary outcome [1] 420232 0
changes in mood (measured using the Profile of Mood States, POMS)
Timepoint [1] 420232 0
POMs will be sampled at baseline, following the third writing exercise and again after a 4 week follow up period.

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
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Have a walking disability or be unable to walk easily.

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)
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.
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.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
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)..

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
6/06/2023
Actual
9/06/2023
Date of last participant enrolment
Anticipated
29/10/2023
Actual
Date of last data collection
Anticipated
3/11/2023
Actual
Sample size
Target
90
Accrual to date
9
Final
Recruitment outside Australia
Country [1] 25361 0
New Zealand
State/province [1] 25361 0
Auckland

Funding & Sponsors
Funding source category [1] 313534 0
University
Name [1] 313534 0
University of Auckland
Country [1] 313534 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Department of Psychological Medicine
The University of Auckland
Level 3
22-30 Park Ave, Grafton
Auckland 1023,
New Zealand
Country
New Zealand
Secondary sponsor category [1] 315314 0
None
Name [1] 315314 0
Address [1] 315314 0
Country [1] 315314 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 312716 0
Auckland Health Research Ethics Committee
Ethics committee address [1] 312716 0
Auckland Health Research Ethics Committee
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Ethics committee country [1] 312716 0
New Zealand
Date submitted for ethics approval [1] 312716 0
13/03/2023
Approval date [1] 312716 0
17/03/2023
Ethics approval number [1] 312716 0
AH25540

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.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 125654 0
Prof Elizabeth Broadbent
Address 125654 0
Faculty of Medical and Health Science
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 125654 0
New Zealand
Phone 125654 0
+64 9 3737599
Fax 125654 0
Email 125654 0
e.broadbent@auckland.ac.nz
Contact person for public queries
Name 125655 0
Prof Elizabeth Broadbent
Address 125655 0
Faculty of Medical and Health Science
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 125655 0
New Zealand
Phone 125655 0
+64 9 3737599
Fax 125655 0
Email 125655 0
e.broadbent@auckland.ac.nz
Contact person for scientific queries
Name 125656 0
Prof Elizabeth Broadbent
Address 125656 0
Faculty of Medical and health Science
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country 125656 0
New Zealand
Phone 125656 0
+64 9 3737599
Fax 125656 0
Email 125656 0
e.broadbent@auckland.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
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.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
18796Study protocol  e.broadbent@auckland.ac.nz
18797Statistical analysis plan  e.broadbent@auckland.ac.nz
18798Ethical approval  e.broadbent@auckland.ac.nz



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.