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Trial registered on ANZCTR


Registration number
ACTRN12623000656639
Ethics application status
Approved
Date submitted
27/05/2023
Date registered
19/06/2023
Date last updated
23/06/2024
Date data sharing statement initially provided
19/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The efficacy of a brief self-compassionate writing intervention for affect and pregnancy wellbeing in women with Gestational Diabetes Mellitus (GDM): A randomised Controlled Trial
Scientific title
The efficacy of a brief self-compassionate writing intervention for affect and pregnancy wellbeing in women with Gestational Diabetes Mellitus (GDM): A randomised Controlled Trial
Secondary ID [1] 309684 0
Nil known
Universal Trial Number (UTN)
U1111-1292-8362
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 330061 0
Pregnancy 330218 0
Condition category
Condition code
Metabolic and Endocrine 326961 326961 0 0
Diabetes
Reproductive Health and Childbirth 327087 327087 0 0
Fetal medicine and complications of pregnancy

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-compassion intervention:
-The intervention will be individually completed via an electronic survey link accessed on the participants own personal device. Participants will be asked to spend 3 minutes writing a paragraph to themselves according to the instructions provided. The instructions will state, “For the next 3 minutes write a paragraph to yourself (as if you are addressing yourself) expressing kindness, compassion, and understanding towards yourself regarding your mood, well-being, and self-care motivation during your pregnancy”. Written responses will be inspected to assess adherence to the instructions.
-The intervention consists of 1 x 3 minute writing session, completed once only
-There is no one administering the intervention given the online survey is conducted via Qualtrics
-The researchers will be reviewing the intervention responses
Intervention code [1] 326129 0
Treatment: Other
Intervention code [2] 326176 0
Behaviour
Comparator / control treatment
Positive distraction intervention:
The intervention will be individually completed via an electronic survey link accessed on the participants own personal device. Participants will be asked to spend 3 minutes writing a paragraph to themselves according to the instructions provided. The instructions will state, “For the next 3 minutes, write a paragraph to yourself (as if you are addressing yourself) describing a hobby that you enjoy, and please list the reasons why you enjoy this hobby.” Written responses will be inspected to assess adherence to the instructions.
-The intervention consists of 1 x 3 minute writing session, completed once only
-There is no one administering the intervention given the online survey is conducted via Qualtrics
-The researchers will be reviewing the intervention responses
Control group
Active

Outcomes
Primary outcome [1] 334797 0
The State Self-Compassion Scale Short Form (SSCS-S)
Timepoint [1] 334797 0
Pre-intervention and post-intervention (immediately post-intervention)
Primary outcome [2] 334800 0
Positive and Negative Affect Schedule (PANAS-SF) for the overall assessment of affect
Timepoint [2] 334800 0
Pre-intervention and post-intervention (immediately post-intervention)
Primary outcome [3] 334801 0
The Well-being in Pregnancy (WiP) questionnaire
Timepoint [3] 334801 0
Pre-intervention and post-intervention (immediately post-intervention)
Secondary outcome [1] 422118 0
Intentions to engage in self-care behaviours assessed independently
-A composite secondary single-item measure developed for this study
Timepoint [1] 422118 0
Pre-intervention and post-intervention (immediately post-intervention)
Secondary outcome [2] 422306 0
Intentions to engage in help-seeking behaviours assessed independently
-A composite secondary single-item measure developed for this study
Timepoint [2] 422306 0
Pre-intervention and post-intervention (immediately post-intervention)
Secondary outcome [3] 422878 0
The Intrinsic Motivation Inventory (IMI) to assess intrinsic enjoyment and perceived value of the writing task
Timepoint [3] 422878 0
Post-intervention only (immediately post-intervention)

Eligibility
Key inclusion criteria
Eligible participants are Western Health patients 18 years of age or above who are currently pregnant with a diagnosis of GDM and planning on delivering at Joan Kirner Sunshine Hospital (Western Health), can read and write in English, and are able to use a smart phone, tablet, or computer (with reliable access to the internet)
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria
Participants who are experiencing a healthy or normal pregnancy and therefore are not diagnosed with GDM.

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)
This will occur using concealed central randomisation via Qualtrics electronic survey software.
The researcher is not required to manually enrol or assign participants to the intervention as this will be automatically completed by Qualtrics.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
This will occur using computerised sequence generation. Participants will be randomly allocated to either the self-compassion (intervention) or positive distraction (control) group using the Qualtrics randomisation function to eliminate confounding factors.
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
An a priori power analysis using G*Power software revealed that a sample size of 150 participants would be sufficient to detect a medium effect in 2 x 2 mixed model ANOVA (f = 0.25) with 80% power and an alpha of .05. As there could be some attrition or participants not completing the intervention, it is intended that a minimum sample of 200 participants will be recruited (100 in each group).
The efficacy of the writing task will be analysed using a 2 (Group: intervention, control) x 2 (Time: pre-intervention, post-intervention) mixed ANOVA. Follow-up tests will compare the self-compassion group to the control group at each time point as relevant for the measure. Trait variables may be included in analyses as covariates or to check for moderation as relevant.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
1/09/2023
Actual
16/01/2024
Date of last participant enrolment
Anticipated
1/03/2025
Actual
Date of last data collection
Anticipated
1/03/2025
Actual
Sample size
Target
200
Accrual to date
57
Final
Recruitment in Australia
Recruitment state(s)
VIC
Recruitment hospital [1] 24796 0
Joan Kirner Women’s and Children’s Hospital - St Albans
Recruitment postcode(s) [1] 40439 0
3021 - St Albans

Funding & Sponsors
Funding source category [1] 313878 0
Hospital
Name [1] 313878 0
Western Health Hospital
Country [1] 313878 0
Australia
Funding source category [2] 314060 0
University
Name [2] 314060 0
Deakin University
Country [2] 314060 0
Australia
Primary sponsor type
Individual
Name
Dr Robyn Moffitt
Address
Deakin University, 221 Burwood Highway, Burwood, Victoria 3125
Country
Australia
Secondary sponsor category [1] 315724 0
Individual
Name [1] 315724 0
A/Prof Peter Shane Hamblin
Address [1] 315724 0
Western Health Sunshine Hospital, 176 Furlong Rd, St Albans VIC 3021
Country [1] 315724 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313025 0
Western Health Low Risk Ethics Panel
Ethics committee address [1] 313025 0
Western Health Office for Research
Level 3, Western Centre for Health, Research & Education (CHRE)
Sunshine Hospital, Furlong Rd, St Albans VIC 3021
Ethics committee country [1] 313025 0
Australia
Date submitted for ethics approval [1] 313025 0
19/08/2022
Approval date [1] 313025 0
16/11/2022
Ethics approval number [1] 313025 0
HREC/22/WH/86484
Ethics committee name [2] 313026 0
Deakin University Human Research Ethics Committee
Ethics committee address [2] 313026 0
Deakin University
75 Pigdons Road, Waurn Ponds, VIC 3216
Ethics committee country [2] 313026 0
Australia
Date submitted for ethics approval [2] 313026 0
09/02/2023
Approval date [2] 313026 0
14/02/2023
Ethics approval number [2] 313026 0
2023-037

Summary
Brief summary
The aim of this RCT is to investigate whether a written self-compassion intervention can improve affect and pregnancy wellbeing in women with GDM. For this study, participants will be randomly allocated to either the self-compassion or positive distraction group. It is anticipated that participants allocated to the self-compassion reflective writing task (using expressions of self-warmth and self-kindness) will report lower levels of affect, and enhanced pregnancy wellbeing at post-intervention relative to participants allocated to the positive distraction group.
The outcome measures will include self-compassion, positive and negative affect, pregnancy wellbeing, and intentions to engage in self-care and help-seeking behaviours.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 126726 0
A/Prof Peter Shane Hamblin
Address 126726 0
Sunshine Hospital
176 Furlong Road
St Albans, VIC, 3021
Country 126726 0
Australia
Phone 126726 0
+6138345 6666
Fax 126726 0
Email 126726 0
peter.hamblin@wh.org.au
Contact person for public queries
Name 126727 0
Dr Robyn Moffitt
Address 126727 0
Deakin University
221 Burwood Hwy, Burwood VIC 3125
Country 126727 0
Australia
Phone 126727 0
+61392446963
Fax 126727 0
Email 126727 0
r.moffitt@deakin.edu.au
Contact person for scientific queries
Name 126728 0
Dr Robyn Moffitt
Address 126728 0
Deakin University
221 Burwood Hwy, Burwood VIC 3125
Country 126728 0
Australia
Phone 126728 0
+61392446963
Fax 126728 0
Email 126728 0
r.moffitt@deakin.edu.au

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
Only aggregated participant data will be published.


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.