Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12620000448943
Ethics application status
Approved
Date submitted
1/04/2020
Date registered
6/04/2020
Date last updated
22/10/2021
Date data sharing statement initially provided
6/04/2020
Type of registration
Prospectively registered

Titles & IDs
Public title
Expressive Writing To Combat Distress Associated With The COVID-19 Pandemic In People With Inflammatory Bowel Disease
Scientific title
Expressive Writing To Combat Distress Associated With The COVID-19 Pandemic In People With Inflammatory Bowel Disease
Secondary ID [1] 300899 0
Nil known
Universal Trial Number (UTN)
Trial acronym
WriteForIBD
Linked study record

Health condition
Health condition(s) or problem(s) studied:
inflammatory bowel disease 316833 0
Crohn's disease 316834 0
ulcerative colitis 316835 0
indeterminate colitis 316836 0
COVID-19 316973 0
Condition category
Condition code
Oral and Gastrointestinal 315043 315043 0 0
Inflammatory bowel disease
Oral and Gastrointestinal 315126 315126 0 0
Crohn's disease
Oral and Gastrointestinal 315127 315127 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon
Mental Health 315128 315128 0 0
Anxiety
Mental Health 315129 315129 0 0
Depression
Infection 315130 315130 0 0
Other infectious diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Expressive/gratitude writing intervention – This group will participate in the adapted evidenced-based 4-day writing program (Pennebaker 1997). Participants will meet with the facilitator (a researcher with a Psychology degree) using Zoom / over the phone or will access a recording of the intervention (if the time difference makes a Zoom/phone session impractical) in a group format four times in one week for approx. 30 minutes (25 minutes of writing time). Daily e-mail reminders will be sent during the 4 days of writing. Session structure – 1 min to complete the distress VAS measure (before), 5 minutes write any reflection from last session, 15 minutes spent writing about your thoughts and feelings, 5 minutes writing about the things you are grateful for, 1 min to complete the distress VAS measure (after). The instruction each day will be (adapted from Pennebaker):
“Please write about your thoughts and feelings about your IBD and the recent situation with COVID-19. Try to select something that you had a strong reaction to – perhaps this was a thought that was challenging or unpleasant. Feel free to really let go and explore your very deepest emotions and thoughts. You might tie your topic to your relationships with others, including parents, lovers, friends or relatives, to your past, your present, your future, or to who you have been, who you would like to be, or who you are now. All of your writing will be completely confidential. Please don’t worry about spelling, sentence structure, or grammar. Feel free to type or write by hand.”
Participants will not be asked to share their writing with the study investigators, to ensure free expression.
Intervention code [1] 317233 0
Behaviour
Intervention code [2] 317273 0
Treatment: Other
Intervention code [3] 317274 0
Prevention
Comparator / control treatment
Active control – This group will write about trivial untherapeutic topics for 4 consecutive days. Participants will meet with the facilitator (a researcher with a Psychology degree) using Zoom / over the phone or will access a recording of the intervention (if the time difference makes a Zoom/phone session impractical) in a group format (audio required, video use is optional) four times in one week for approx. 30 minutes (25 minutes of writing time). Daily e-mail reminders will be sent during the 4 days of writing. Session structure: 1 min to complete the distress VAS measure (before), 5 minutes write any reflection from last session, 20 minutes of writing (i.e. day 1 – describe the furniture in your room, day 2 – describe the place of your work, day 3 – describe your suburb, day 4 – describe your best friend), 1 min to complete the distress VAS measure (after).
Control group
Active

Outcomes
Primary outcome [1] 323364 0
Distress measured on Kessler Psychological Distress Scale (K10)
Timepoint [1] 323364 0
Baseline, post-intervention (within one week since the completion of the intervention, primary endpoint), 3 months post-intervention
Secondary outcome [1] 381653 0
Anxiety measured on the DASS
Timepoint [1] 381653 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention
Secondary outcome [2] 381654 0
Quality of life measured on AQOL8D
Timepoint [2] 381654 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention
Secondary outcome [3] 381655 0
Resilience measured on the Brief Resilience Scale
Timepoint [3] 381655 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention
Secondary outcome [4] 381656 0
Self-efficacy measured on the General Self-efficacy Scale
Timepoint [4] 381656 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention
Secondary outcome [5] 381657 0
Perceived social support measured on the Multidimensional Scale of Perceived Social Support
Timepoint [5] 381657 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention
Secondary outcome [6] 381658 0
Disease activity measured on Manitoba Index and IBD Control Scale
Timepoint [6] 381658 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention
Secondary outcome [7] 381659 0
Satisfaction measured using the following:

1. VAS 0-10 satisfaction rating:
On a scale from 0-10 how satisfied are you with the writing intervention you participated in?

2. Open-ended questions: what was the best aspect of this intervention? What was the worst aspect of this intervention? How did the writing experience affect your mental health?
Timepoint [7] 381659 0
Post-intervention (within one week since the completion of the intervention)
Secondary outcome [8] 381825 0
Depression measured on the DASS
Timepoint [8] 381825 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention
Secondary outcome [9] 381826 0
Stress measured on the DASS
Timepoint [9] 381826 0
Baseline, post-intervention (within one week since the completion of the intervention), 3 months post-intervention

Eligibility
Key inclusion criteria
Diagnosis of IBD: Crohn’s disease, ulcerative colitis or indeterminate colitis established using standard criteria (we will ask for the details of patient's gastroenterologist, and these will be verified by our team);
Distress: at least mild distress on K10 (scores 20-29);
Age: 18 years and older;
Other: able to read and write in English, with access to internet/telephone to participate in online/telephone intervention and available to participate for approx. 30 minutes for 4 consecutive days (likely in the evening).
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
Severe distress based on K10 (scores 30-50 very high distress) as these participants would require a more intensive therapeutic approach.

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 involve contacting the holder of the allocation schedule (the study statistician) who is based at central administration site with no access to participants
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. computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Patients in both treatment arms will remain on their current IBD medication. All participants will complete questionnaires before and after the intervention and at 3 months post-intervention.
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Analyses will be carried out on intention-to-treat basis, and significance tests will be two-sided at the 5% level. No adjustment for multiple testing will be made to p-values, however, effect sizes for each outcome measure will be presented. The study hypothesis will be tested with the linear mixed effects models which are known to compensate for missing data. In these models, the dependent variable is the outcome measure, with predictors being Time, Group and the Interaction between Time and Group - the coefficient for Interaction being the formal test of the hypothesis. A per protocol analysis will also be undertaken, with adjustment for adherence to intervention. The latter will be defined as =80% of sessions completed. Other adjustments (e.g. age, sex) will be made, if required. We will also conduct an exploratory analysis to stratify by treatment (e.g. biologics versus steroids).

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Participant recruitment difficulties
Date of first participant enrolment
Anticipated
1/06/2020
Actual
20/06/2020
Date of last participant enrolment
Anticipated
30/06/2021
Actual
7/06/2021
Date of last data collection
Anticipated
1/10/2021
Actual
8/09/2021
Sample size
Target
154
Accrual to date
Final
19
Recruitment in Australia
Recruitment state(s)
ACT,NSW,NT,QLD,SA,TAS,WA,VIC
Recruitment outside Australia
Country [1] 23294 0
New Zealand
State/province [1] 23294 0
all country
Country [2] 23295 0
Singapore
State/province [2] 23295 0
all country
Country [3] 23922 0
United Kingdom
State/province [3] 23922 0
all country
Country [4] 23923 0
United States of America
State/province [4] 23923 0
all country
Country [5] 23924 0
Canada
State/province [5] 23924 0
all country
Country [6] 23925 0
South Africa
State/province [6] 23925 0
all country

Funding & Sponsors
Funding source category [1] 305349 0
University
Name [1] 305349 0
Deakin University Faculty of Health Mid-Career Fellowship
Country [1] 305349 0
Australia
Funding source category [2] 307448 0
Commercial sector/Industry
Name [2] 307448 0
Janssen Australia
Country [2] 307448 0
Australia
Primary sponsor type
University
Name
Deakin University
Address
Faculty of Health
Deakin University
221 Burwood Highway
3125 Burwood VIC
Country
Australia
Secondary sponsor category [1] 305736 0
Charities/Societies/Foundations
Name [1] 305736 0
Crohn's & Colitis Australia
Address [1] 305736 0
4/363 Camberwell Rd, Camberwell VIC 3124
Country [1] 305736 0
Australia
Other collaborator category [1] 281254 0
Hospital
Name [1] 281254 0
Barwon Health
Address [1] 281254 0
University Hospital Geelong
Bellerine Street
PO Box 281
Geelong VIC 3220
Country [1] 281254 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 305681 0
Deakin University Human Research Ethics Committee
Ethics committee address [1] 305681 0
Ethics committee country [1] 305681 0
Australia
Date submitted for ethics approval [1] 305681 0
01/04/2020
Approval date [1] 305681 0
26/05/2020
Ethics approval number [1] 305681 0
2020-122

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

Contacts
Principal investigator
Name 101210 0
A/Prof Antonina Mikocka-Walus
Address 101210 0
School of Psychology, Deakin University, 221 Burwood Highway, Burwood 3125 VIC
Country 101210 0
Australia
Phone 101210 0
+61 3 924 68575
Fax 101210 0
Email 101210 0
[email protected]
Contact person for public queries
Name 101211 0
Antonina Mikocka-Walus
Address 101211 0
School of Psychology, Deakin University, 221 Burwood Highway, Burwood 3125 VIC
Country 101211 0
Australia
Phone 101211 0
+61 3 924 68575
Fax 101211 0
Email 101211 0
[email protected]
Contact person for scientific queries
Name 101212 0
Antonina Mikocka-Walus
Address 101212 0
School of Psychology, Deakin University, 221 Burwood Highway, Burwood 3125 VIC
Country 101212 0
Australia
Phone 101212 0
+61 3 924 68575
Fax 101212 0
Email 101212 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
We did not seek permission from our REC to share the data as we believe participants (a chronically ill cohort) might be reluctant to participate if we decided to share their health-related data. Further, we are initiating a program of research in this area and want our team to be able to use the data in future publications. This is not a large dataset and thus by opening it to others we might lose the opportunity to publish the data ourselves.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
10075Ethical approval    379538-(Uploaded-16-11-2020-14-20-20)-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
SourceTitleYear of PublicationDOI
EmbaseExpressive writing to combat distress associated with the COVID-19 pandemic in people with inflammatory bowel disease (WriteForIBD): A trial protocol.2020https://dx.doi.org/10.1016/j.jpsychores.2020.110286
N.B. These documents automatically identified may not have been verified by the study sponsor.