Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12619000822189
Ethics application status
Approved
Date submitted
21/05/2019
Date registered
6/06/2019
Date last updated
6/06/2019
Date data sharing statement initially provided
6/06/2019
Type of registration
Retrospectively registered

Titles & IDs
Public title
The impact of writing interventions on wellbeing in healthy adults.
Scientific title
Can clarifying values improve wellbeing? A comparison of writing interventions in healthy adults.
Secondary ID [1] 298204 0
Nil known
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Depressed mood 312793 0
Condition category
Condition code
Mental Health 311291 311291 0 0
Studies of normal psychology, cognitive function and behaviour
Mental Health 311292 311292 0 0
Depression
Public Health 311322 311322 0 0
Other public health

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
All components of this study are web-delivered, completed in participants’ homes and in their own time. The study is divided into 4 parts, which participants complete (individually) at four separate time-points (i.e., pretest survey; writing activity [intervention]; follow-up 1 [7 days postintervention]; follow-up 2 [4 weeks postintervention]). Total participation time is around 90 minutes or less, divided into shorter intervals and delivered over the span of 5 weeks. At pretest, participants read an instructions page detailing the general aims of this study as well as requirements for participating. They must then provide their consent before moving on to the survey. The self-report questionnaires ask about participants’ demographic details, emotions, behaviour patterns, values, sense of meaning/purpose, and life satisfaction. This survey takes approximately 20 minutes to complete. Within 48 hours of submitting their responses, participants are then randomised to one of three conditions (Intervention 1, Intervention 2, or Control) and emailed a link providing them access to their allocated writing activity, as well as instructions that this task must be completed within 7 days from completion of the pretest survey. All participants receive web-delivered written instructions prior to beginning their activity, and all 3 conditions require participants to reflect on aspects of their personal experience and write down their thoughts. All participants are asked to please spend a minimum of 20 minutes on their activity. Directly after the writing task, participants complete a brief post-test survey (less than 5 minutes) requiring them to rate their present emotional state and to evaluate the writing activity along several indices. After completing the intervention, all participants receive a copy of their work (Word document emailed to them). The email also encourages them to continue working on the activity in their own time. Lastly, At 2 follow-up points (1 week and 1 month postintervention), participants are emailed a link to the same set of surveys delivered at pretest. These follow-up surveys require roughly 15 minutes of participants' time at each sitting.

Intervention 1: after reading an instructions page in which personal values and values-consistent activities are defined, participants complete an online procedure whereby they: (1) select the Life Area they would like to work on (Life Areas consist of “Relationships”, “Education/Career”, “Mind/Body/Spirituality”, “Recreation/Interests”, and “Daily Responsibilities”); (2) participants specify their values (up to 3) in their chosen Life Area; (3) participants identify particular activities (1-3 per each value) which would work toward or be consistent with one of their specified values. Participants have the option of working through up to 3 different Life Areas, or they may opt out after exploring one. (4) after electing to “submit” their written work, participants complete the brief post-test survey.

Intervention 2: after reading an instructions page in which the concept of one’s “best possible future self” is defined, participants complete an online procedure wherein they: (1) write about their individual conception of their ideal self in the future, detailing how they imagine their lives would look once all dreams and aspirations have been met; (2) after electing to “submit” their written work, participants complete the brief post-test survey.

Self-reported engagement with intervention: A 12-item self-report questionnaire will be administered immediately post-intervention asking participants to evaluate their assigned writing activity along several dimensions. Participants will rate these items from 1 (strongly disagree) to 5 (strongly agree). To ascertain whether the interventions were evaluated positively or negatively, participants will rate how enjoyable, important, emotional, difficult and upsetting they found the task. Two items will additionally assess mental imagery elicited by the task. Motivation, effort and engagement in the activity will each be measured by one item. Finally, two items will ask participants to rate (1) the extent to which they feel able to control important outcomes in their lives, and (2) the confidence they feel in their ability to take steps toward valued goals.

Within 48 hours of completing the intervention, participants will be emailed a copy of the instructions for their assigned intervention in addition to a copy of their work (Word Document). The email will contain a reminder message in which participants are encouraged to continue building on their activity in their own time. It also states that this additional performance is optional and does not need to be submitted.

At both follow-up times, 1-week postintervention and 4-weeks post-intervention, one item will examine the extent to which participants reflected on/continued working on their assigned activity following the initial intervention. Participants will be asked to quantify the number of times they performed the activity (a) in the past week (at 1-week follow-up) and (b) over the past month (at 4-weeks follow-up).



Intervention code [1] 314478 0
Treatment: Other
Intervention code [2] 314479 0
Lifestyle
Intervention code [3] 314480 0
Behaviour
Comparator / control treatment
After reading an instructions page directing participants to write about an ordinary day in their lives, participants assigned to the control condition then complete an online procedure consisting of: (1) writing about a typical day in their life, focusing on the ordinary details of that day and writing in as much objective factual detail as they can (e.g., as though moving through that day, hour after hour); (2) after electing to “submit” their written work, participants complete the brief post-test survey.
Control group
Active

Outcomes
Primary outcome [1] 320064 0
Change in emotional distress as measured by the Depression Anxiety Stress Scales-21 (DASS-21)
Timepoint [1] 320064 0
All participants will be assessed on the DASS-21 at three timepoints: baseline, week 1 (primary endpoint) and week 4.
Baseline: survey administered preintervention (maximum of 7 days prior to intervention)
Follow-up 1: 7 days postintervention (primary endpoint)
Follow-up 1: 4 weeks postintervention

Primary outcome [2] 320065 0
Change in positive and negative affect as measured by the Positive and Negative Affect Schedule (PANAS)
Timepoint [2] 320065 0
All participants will be assessed on the PANAS at four timepoints: baseline, post-test (primary endpoint), week 1 and week 4.
Baseline: pretest survey, administered at a maximum of 7 days preintervention
Postintervention: immediately postintervention (writing activity) completion (primary endpoint)
Follow-up 1: 7 days postintervention
Follow-up 1: 4 weeks postintervention
Primary outcome [3] 320218 0
Change in general life satisfaction, as measured by the Satisfaction With Life Scale (SWLS).
Timepoint [3] 320218 0
All participants will be assessed on the SWLS at three timepoints: baseline, week 1 (primary endpoint) and week 4.
Baseline: survey administered preintervention (maximum of 7 days prior to intervention)
Follow-up 1: 7 days postintervention (primary endpoint)
Follow-up 1: 4 weeks postintervention
Secondary outcome [1] 370416 0
*Primary Outcome*
Change in values-consistent living, as measured by the Valued Living Questionnaire (VLQ).
Timepoint [1] 370416 0
All participants will be assessed on the VLQ at three timepoints: baseline, week 1 (primary endpoint) and week 4.
Baseline: survey administered preintervention (maximum of 7 days prior to intervention)
Follow-up 1: 7 days postintervention (primary endpoint)
Follow-up 1: 4 weeks postintervention
Secondary outcome [2] 370417 0
*Primary Outcome*
Change in level of behavioural activation, as measured by the Behavioural Activation for Depression Scale – Short-Form (BADS-SF)
Timepoint [2] 370417 0
All participants will be assessed on the BADS-SF at three timepoints: baseline, week 1 (primary endpoint) and week 4.
Baseline: survey administered preintervention (maximum of 7 days prior to intervention)
Follow-up 1: 7 days postintervention (primary endpoint)
Follow-up 1: 4 weeks postintervention
Secondary outcome [3] 370902 0
*Primary Outcome*
Change in self-reported eudaimonic wellbeing indices, as measured by the Questionnaire for Eudaimonic Wellbeing (QEWB)
Timepoint [3] 370902 0
All participants will be assessed on the QEWB at three timepoints: baseline, week 1 (primary endpoint) and week 4.
Baseline: survey administered preintervention (maximum of 7 days prior to intervention)
Follow-up 1: 7 days postintervention (primary endpoint)
Follow-up 1: 4 weeks postintervention

Eligibility
Key inclusion criteria
At least 18 years of age; English language fluency.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Exclusion criteria: Individuals who are currently experiencing the acute effects of a psychological disorder(s).

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Allocation is not concealed.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Stratified allocation using computerised sequence generation. Gender (male/female) was the factor used for the 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
The primary data of interest will be the self-report questionnaires completed by participants. To analyse the first hypothesis – that the active interventions will be associated with a significant increase in positive emotions compared to the control condition, a 3 x 2 mixed design Analysis of Variance (ANOVA) will be performed. The three independent variables will be condition: Intervention1, Intervention2, or Control. The repeated measures variable will be participants’ self-reported mood ratings (PANAS scores) immediately pre-and-postintervention. It will be assessed whether condition interacted with time such that the active interventions led to immediate increases in positive emotions relative to the control condition.

To analyse the additional hypotheses – that the beneficial effects of participating in the active conditions (as indicated via superior self-report ratings on the wellbeing measures) relative to those in the control condition will be maintained at Time 2 (1 week follow-up) and Time 3 (4 weeks follow-up) – a similar method will be employed. A 3 x 3 mixed design ANOVA will be conducted with condition as the independent variable and Times 1 (preintervention), Time 2 (1 week postintervention), and Time 3 (4 weeks postintervention) as the repeated measures variables. The dependent variables (self-report wellbeing ratings) will be partitioned into four conceptually distinct groups comprising (1) emotional distress (as measured by the DASS-21), hedonic wellbeing (as measured by the PANAS and SWLS), eudaimonic wellbeing (as measured by the QEWB and the VLQ), and general positive functioning (as assessed by the BADS-SF). To control for inflation of familywise error rate in the hedonic and eudaimonic categories, each will be analysed at a Bonferroni adjusted alpha-level of .025.

To explore whether participant ratings of their assigned activity differed according to which writing task they completed, a series of between-subjects one-way ANOVAs will be employed. Condition will be the between-subjects factor and participants’ evaluation of experimental task will be the dependent variable. It will in this way be determined whether the extent to which participants enjoyed their assigned activity significantly differed according to condition.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
17/04/2019
Date of last participant enrolment
Anticipated
20/09/2019
Actual
Date of last data collection
Anticipated
25/10/2019
Actual
Sample size
Target
70
Accrual to date
21
Final
Recruitment in Australia
Recruitment state(s)
WA

Funding & Sponsors
Funding source category [1] 302748 0
University
Name [1] 302748 0
Curtin University
Country [1] 302748 0
Australia
Primary sponsor type
University
Name
Curtin University
Address

Faculty of Health Sciences,
School of Psychology
Curtin University, Bentley Campus
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 302724 0
Individual
Name [1] 302724 0
Dr Trevor Mazzucchelli
Address [1] 302724 0

Faculty of Health Sciences,
School of Psychology
Curtin University, Bentley Campus
Kent St, Bentley WA 6102
Country [1] 302724 0
Australia
Other collaborator category [1] 280717 0
Individual
Name [1] 280717 0
Temily Cao
Address [1] 280717 0

Faculty of Health Sciences,
School of Psychology
Curtin University, Bentley Campus
Kent St, Bentley WA 6102
Country [1] 280717 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 303347 0
Curtin University Human Research Ethics Committee (HREC)
Ethics committee address [1] 303347 0
Ethics committee country [1] 303347 0
Australia
Date submitted for ethics approval [1] 303347 0
02/03/2018
Approval date [1] 303347 0
28/03/2018
Ethics approval number [1] 303347 0
HRE2018-0132

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

Contacts
Principal investigator
Name 93362 0
Dr Trevor Mazzucchelli
Address 93362 0
Room 401.116,
Psychology Building,
Curtin University, Bentley Campus
Kent St, Bentley WA 6102
Country 93362 0
Australia
Phone 93362 0
+61 892667182
Fax 93362 0
Email 93362 0
[email protected]
Contact person for public queries
Name 93363 0
Temily Cao
Address 93363 0
Psychology Building,
Curtin University, Bentley Campus
Kent St, Bentley WA 6102
Country 93363 0
Australia
Phone 93363 0
+61 434 8349 084
Fax 93363 0
Email 93363 0
[email protected]
Contact person for scientific queries
Name 93364 0
Trevor Mazzucchelli
Address 93364 0
Room 401.116,
Psychology Building,
Curtin University, Bentley Campus
Kent St, Bentley WA 6102
Country 93364 0
Australia
Phone 93364 0
+61 892667182
Fax 93364 0
Email 93364 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
Participants' responses on the primary outcome measures of interest (self-report questionnaires) will be included in the written report of this study. Participant data will be completely deidentified wherever IPD are shared.
When will data be available (start and end dates)?
Beginning immediately following publication; no end date determined.
Available to whom?
Data will be made available on a case-by-case basis, at the discretion of Primary Sponsor.
Available for what types of analyses?
Any purpose.
How or where can data be obtained?
Access subject to approvals by Principal Investigator


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
2096Ethical approval    377576-(Uploaded-15-05-2019-00-18-13)-Study-related document.pdf
2097Informed consent form    Informed consent & study protocol. 377576-(Uploaded-15-05-2019-00-46-05)-Study-related document.pdf



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.