ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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]

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.

Condition category

Condition code

Mental Health

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]

Treatment: Other

Intervention code [2]

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]

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]

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]

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]

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]

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]

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]

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]

SecondaryTimepoint 3: The participants will be asked to respond to the question at seven (7) day follow up.

Secondary outcome [4]

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]

This secondary outcome will be assessed immediately after completing the intervention, and again at seven (7) day follow up.

Secondary outcome [5]

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]

This secondary outcome will be assessed immediately after completing the intervention,

Secondary outcome [6]

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]

This secondary outcome will be measured immediately after completing the intervention.

Secondary outcome [7]

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]

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

Final

Recruitment in Australia

Recruitment state(s)

NSW,WA,VIC

Recruitment outside Australia

Country [1]

United Kingdom

State/province [1]

All

Country [2]

United States of America

State/province [2]

All

Funding & Sponsors

Funding source category [1]

University

Name [1]

Curtin University

Address [1]

Curtin University
Kent St, Bentley WA 6102

Country [1]

Australia

Primary sponsor type

University

Name

Curtin University

Address

Curtin University
Kent St, Bentley WA 6102

Country

Australia

Secondary sponsor category [1]

University

Name [1]

University of Queensland

Address [1]

University of Queensland
Sir Fred Schonell Dr
St Lucia QLD 4067

Country [1]

Australia

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Curtin University Human Research Ethics Committee

Ethics committee address [1]

Curtin University 
Kent St, Bentley WA 6102

Ethics committee country [1]

Australia

Date submitted for ethics approval [1]

02/07/2021

Approval date [1]

19/08/2021

Ethics approval number [1]

HRE2021-0495

Summary

Brief summary

Writing is a cost-efficient intervention that has been shown to help people cope with negative life events by expressively writing about that particular experience. This study investigates if a self-compassionate attitude influences the way in which we provide self-advice regarding our experiences, and to understand if this approach is more helpful than a relaxed mindset. 

Despite the growing evidence regarding self-compassion, there is a paucity of research on our understanding of the perceived usefulness of self-compassionate writing, and the likelihood of participants engaging in this treatment. The present study aims to examine the acceptability and effectiveness of self-compassionate writing to cope with personal problems. 

A randomised controlled design with longitudinal follow up was adopted for this study. Participants will be randomly assigned into either the self-compassion writing condition or the relaxation breathing control writing condition, with outcome measures administered at three intervals (pretest, post-test, and 1-week follow-up). In the initial phase, participants will be encouraged to write about a personal problem which caused them to feel failure, humiliation, or rejection. They will then be directed to listen to a 10 minute audio recording, either a self-compassionate or relaxation breathing recording dependant on random group assignment. and provide self-advice related to the problem previously described.

All participants will be administered the Positive and Negative Affect Scale, the Compassion Motivation and Action Scale, and other questionnaires related to problem intensity, helpfulness of their self-advice, and the likelihood that would use this approach to address future personal problems.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Trevor Mazzucchelli

Address

Curtin University
Kent St, Bentley WA 6102

Country

Australia

Phone

+61 8 9266 7182

Fax

trevor.mazzucchelli@curtin.edu.au

Contact person for public queries

Name

Trevor Mazzucchelli

Address

Curtin University
Kent St, Bentley WA 6102

Country

Australia

Phone

+61 8 9266 7182

Fax

trevor.mazzucchelli@curtin.edu.au

Contact person for scientific queries

Name

Trevor Mazzucchelli

Address

Curtin University
Kent St, Bentley WA 6102

Country

Australia

Phone

+61 8 9266 7182

Fax

trevor.mazzucchelli@curtin.edu.au

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.	Type	Citation	Link	Email	Other Details	Attachment
12941	Informed consent form					382488-(Uploaded-19-08-2021-17-04-24)-Study-related document.pdf
12942	Ethical 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.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically