Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12622001098729
Ethics application status
Approved
Date submitted
19/08/2021
Date registered
9/08/2022
Date last updated
9/08/2022
Date data sharing statement initially provided
9/08/2022
Type of registration
Retrospectively registered

Titles & IDs
Public title
The quality of self-advice: The effect of self-compassionate writing on the perception of negative events in a community sample of adults
Scientific title
The quality of self-advice: How are negative events perceived in a community sample of adults following a self-compassion induction?
Secondary ID [1] 304899 0
Nil
Universal Trial Number (UTN)
N/A
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
A perceived personal problem, which caused feelings of humiliation, failure, or rejection. 323025 0
Condition category
Condition code
Mental Health 320593 320593 0 0
Studies of normal psychology, cognitive function and behaviour

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Self-Compassionate Writing Task

1. The intervention comprises of a pre-intervention writing task, listening to a 10 minute compassion audio recording, and a post intervention self-advice writing task.

2. After initial questionnaires have been completed, participants will be invited to write about a personal problem that generated feelings of failure, humiliation, or rejection.

3. Participants will then be directed to listen to a 10-minute compassion-meditation to induce a self-compassionate attitude before commencing the self-advice writing exercise. The compassion-meditation audio recording was created by Dr James Kirby of the University of Queensland to be used in this study. The audio is not a readily available resource.

4. After listening to the compassion audio, participants will be encouraged to complete an adapted version of the writing exercise developed by Leary et al. (2007). The writing tasks directs the participant to provide self-advice for the problem they wrote about previously, using prompting questions such as "What do you tell yourself about this problem?" and "What advice would you give yourself about this problem?".

5. Participants will then be asked to complete post intervention questionnaires related to affect, self-compassion behaviour, and other questions related to problem intensity, helpfulness of their self-advice, how they new feel about their problem.

6. The study is conducted over two time points, one week apart. Participants are advised that the part one questionnaires, audio, and writing exercises will take approximately 30-40 minutes, however, there is no time limit. Part two, consisting of questionnaires only, will be completed one week after part one and will take approximately 10 minutes.

7. Participants will complete the study on-line from a location of their choice. They will require a computer and access to the internet.
Intervention code [1] 321291 0
Treatment: Other
Intervention code [2] 321740 0
Behaviour
Comparator / control treatment
Active Control Relaxation Writing Task

1. The intervention comprises a pre-intervention writing task, listening to a 10 minute relaxation breathing audio recording, and a post intervention self-advice writing task.

2. After initial questionnaires have been completed, participants will be invited to write about a personal problem that generated feelings of failure, humiliation, or rejection.

3. Participants will then be directed to listen to a 10-minute relaxation breathing audio recording before commencing the self-advice writing exercise. The relaxation breathing audio recording was created by Dr James Kirby of the University of Queensland to be used in this study. The audio is not a readily available resource.

4. After listening to the relaxation breathing audio, participants will be encouraged to complete an adapted version of the writing exercise developed by Leary et al. (2007). The writing tasks directs the participant to provide self-advice for the problem they wrote about previously, using prompting questions such as "What do you tell yourself about this problem?" and "What advice would you give yourself about this problem?".

5. Participants will then be asked to complete post intervention questionnaires related to affect, self-compassion behaviour, and other questions related to problem intensity, helpfulness of their self-advice, how they new feel about their problem.

6. The study is conducted over two time points, one week apart. Participants are advised that the part one questionnaires, audio, and writing exercises will take approximately 30-40 minutes, however, there is no time limit. Part two, consisting of questionnaires only, will be completed one week after part one and will take approximately 10 minutes.

7. Participants will complete the study on-line from a location of their choice. They will require a computer and access to the internet.
Control group
Active

Outcomes
Primary outcome [1] 328432 0
Primary Outcome 1 : Self- Compassion.
Any change in levels of self-compassion will be measured at post-intervention, and at follow-up, as measured by the Compassion Motivation and Action Scale's (CMAS; Steindl et al., 2021) total score.
Timepoint [1] 328432 0
Primary Timepoint 1 : This primary outcome will be measured immediately after completing the intervention, and again at seven (7) day follow up.
Secondary outcome [1] 398993 0
Secondary Outcome 1: Positive Affect.
Any change in levels of positive affect will be measured at pre-intervention, post-intervention, and follow-up, as measured by The Positive and Negative Affect Schedule (PANAS; Watson et al., 1988).
Timepoint [1] 398993 0
Secondary Timepoint 1: This outcome will be measured at pre intervention, immediately after completing the intervention, and again at seven (7) days follow up..
Secondary outcome [2] 398994 0
Secondary Outcome 2: Problem Intensity Rating.
Any change in the perceived intensity of the participants problem between writing about the problem and after providing self-advice, and at follow-up, will be measured by the Problem Intensity Rating. The problem intensity rating scale will ask participants to respond to the following question using a 7 point Likert scale ranging from Not at all to Extreme:
"Overall, how intensely would you rate the problem you experienced?"
Timepoint [2] 398994 0
Secondary Timepoint 2: This outcome will be measured after the initial writing task regarding the personal problem, after the intervention, and again at 7 day follow up..
Secondary outcome [3] 398995 0
Secondary Outcome 3: Future use of a writing approach to manage personal problems.
The likelihood of using a writing approach to manage personal problems in the future will be measured at follow up. The questionnaire will ask participants to respond to the following statement using a 7-point Likert scale ranging from Strongly Disagree to Strongly Agree:
"I am likely to use this writing approach to manage future problems".
Timepoint [3] 398995 0
SecondaryTimepoint 3: The participants will be asked to respond to the question at seven (7) day follow up.
Secondary outcome [4] 401019 0
Secondary outcome 4: The perceived helpfulness of participants self-advice.
Participants will be asked to rate the helpfulness of their self-advice measured using a 7-point Likert scale ranging from strongly agree to strongly agree, by responding to the following statement:
"I found the writing approach helpful in managing my problem".
Timepoint [4] 401019 0
This secondary outcome will be assessed immediately after completing the intervention, and again at seven (7) day follow up.
Secondary outcome [5] 401481 0
Secondary Outcome 5: The perceived supportiveness of participants self-advice.
Participants will be asked to rate the supportiveness of their advice. This outcome will be measured on a 7-point Likert scale ranging from strongly agree to strongly agree.
Timepoint [5] 401481 0
This secondary outcome will be assessed immediately after completing the intervention,
Secondary outcome [6] 401484 0
Secondary Outcome 6: Participants perception of their problem as less of an issue.
Participants will be asked to rate how if they now perceive their personal problem as less of an issue. This outcome will be measured on a 7-point Likert scale ranging from strongly disagree to strongly agree.
Timepoint [6] 401484 0
This secondary outcome will be measured immediately after completing the intervention.
Secondary outcome [7] 412692 0
Secondary Outcome 7: Negative Affect.
Any change in levels of negative affect will be measured at pre-intervention, post-intervention, and follow-up, as measured by The Positive and Negative Affect Schedule (PANAS; Watson et al., 1988).
Timepoint [7] 412692 0
Secondary Timepoint 7: This outcome will be measured at pre intervention, immediately after completing the intervention, and again at seven (7) days follow up..

Eligibility
Key inclusion criteria
Eligible participants include individuals who are over the age of 18-years, fluent in English, have access to the internet, and of any nationality.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Nil

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 concealment was performed using the randomisation feature on Qualtrics Survey.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Qualtrics randomisation feature generates the sequence.
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
Hypotheses will be tested using a Generalised Linear Mixed Model (GLMM), executed via SPSS’s (version 25) GENLINMIXED procedure.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
19/07/2022
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
9/09/2022
Actual
Sample size
Target
150
Accrual to date
47
Final
Recruitment in Australia
Recruitment state(s)
NSW,WA,VIC
Recruitment outside Australia
Country [1] 24934 0
United Kingdom
State/province [1] 24934 0
All
Country [2] 24935 0
United States of America
State/province [2] 24935 0
All

Funding & Sponsors
Funding source category [1] 309271 0
University
Name [1] 309271 0
Curtin University
Country [1] 309271 0
Australia
Primary sponsor type
University
Name
Curtin University
Address
Curtin University
Kent St, Bentley WA 6102
Country
Australia
Secondary sponsor category [1] 310255 0
University
Name [1] 310255 0
University of Queensland
Address [1] 310255 0
University of Queensland
Sir Fred Schonell Dr
St Lucia QLD 4067
Country [1] 310255 0
Australia

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 309110 0
Curtin University Human Research Ethics Committee
Ethics committee address [1] 309110 0
Ethics committee country [1] 309110 0
Australia
Date submitted for ethics approval [1] 309110 0
02/07/2021
Approval date [1] 309110 0
19/08/2021
Ethics approval number [1] 309110 0
HRE2021-0495

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

Contacts
Principal investigator
Name 113010 0
Dr Trevor Mazzucchelli
Address 113010 0
Curtin University
Kent St, Bentley WA 6102
Country 113010 0
Australia
Phone 113010 0
+61 8 9266 7182
Fax 113010 0
Email 113010 0
[email protected]
Contact person for public queries
Name 113011 0
Trevor Mazzucchelli
Address 113011 0
Curtin University
Kent St, Bentley WA 6102
Country 113011 0
Australia
Phone 113011 0
+61 8 9266 7182
Fax 113011 0
Email 113011 0
[email protected]
Contact person for scientific queries
Name 113012 0
Trevor Mazzucchelli
Address 113012 0
Curtin University
Kent St, Bentley WA 6102
Country 113012 0
Australia
Phone 113012 0
+61 8 9266 7182
Fax 113012 0
Email 113012 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?
Individual participant data underlying published results only.
When will data be available (start and end dates)?
Immediately following publication, and data will be stored for 25 years.
Available to whom?
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?
Data can be obtained from the Curtin Research Data Collection.
https://library.curtin.edu.au/about/research-data-collection/


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12941Informed consent form    382488-(Uploaded-19-08-2021-17-04-24)-Study-related document.pdf
12942Ethical approval    382488-(Uploaded-19-08-2021-17-04-40)-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.