Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623000617662
Ethics application status
Approved
Date submitted
26/05/2023
Date registered
6/06/2023
Date last updated
11/08/2024
Date data sharing statement initially provided
6/06/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Positive Beliefs about the Future and Suicidal Ideation in University Students
Scientific title
Evaluating the Efficacy of Positive Episodic Future Thinking (EFT-P) to Increase Positive Beliefs about the Future and Decrease Suicidal Ideation in University Students
Secondary ID [1] 309746 0
None
Universal Trial Number (UTN)
U1111-1293-0495
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidal Ideation 330142 0
Schizotypy 330143 0
Condition category
Condition code
Mental Health 327022 327022 0 0
Suicide

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Participants will complete 8 sessions of positive episodic future thinking (EFT-P) every 4 days, over the course of 28 days. In each of the EFT-P sessions, participants will be provided with a series of audio prompts on the Qualtrics platform, each corresponding to a new visualisation exercise where participants will be encouraged to close their eyes and immerse themselves in the described scenario as though they were actively involved and experiencing it through their own eyes. Each of these sessions will last roughly 15 minutes. On Days 0, 12, 28, and 42, participants will be asked to complete pre-, mid-, post-, and follow-up questionnaires. These will each take roughly 20 minutes to complete.

In each of the sessions during the first and second weeks (Days 0, 4, 8, and 12), formal training exercises will consist of the imagination of four positive hypothetical events. In each exercise, participants will listen to a recording of a script, verbally guiding them through the imagination of a positive scenario or activity. In each session in the third week (Days 16 and 20), there will be three guided exercises. In each exercise, participants will listen to a recording of a script which will prompt them to imagine a pleasant experience that will really happen to them within the next three days. In each session in the fourth week (Days 24 and 28), there will be three guided exercises. In each exercise, participants will listen to a recording of a script which will ask them to think about an event in the far future that involves their idealised self in a future where everything has worked out in the best possible way.

Qualtrics analytics will be used to monitor adherence to the intervention. Completion rates will be tracked for each stage of the intervention, and time spent on activities will be measured to ensure participants are engaging adequately. Response quality will be assessed with manipulation checks after each exercise, evaluating vividness, difficulty, pleasure, and excitement of visualisations. In two open-response spaces, participants will be asked to write down as many details from their visualisation as possible. In addition, psychometric measures in the surveys will incorporate measures of participants' disingenuous responses (e.g., "To show you are reading, select the answer that means strongly disagree").
Intervention code [1] 326187 0
Treatment: Other
Comparator / control treatment
Participants will not complete any sessions of EFT-P. They will complete the same online surveys as the intevention group at the same time points relative to their commencement of participation in the study. That is, participants will be asked to complete four online surveys at Days 0, 12, 28, and 42. These online surveys will contain psychometric measures of suicidal ideation, beliefs related to the future and one's capacity to experience pleasure, mood, schizotypy, and use of mental imagery. Each of these surveys will take roughly 20 minutes to complete.
Control group
Active

Outcomes
Primary outcome [1] 334885 0
Severity of recent suicidal ideation: Suicidal Ideation Attributes Scale (SIDAS).
Timepoint [1] 334885 0
Baseline, 12 days, 28 days (primary timepoint), and 42 days after intervention commencement.
Primary outcome [2] 334943 0
Participants' beliefs related to their future experience of pleasureable events: Beliefs About Pleasure Scale (BAPS).
Timepoint [2] 334943 0
Baseline, 12 days, 28 days (primary timepoint), and 42 days after intervention commencement.
Primary outcome [3] 334944 0
Participants' beliefs related to their ability to enjoy future events: Savoring Beliefs Inventory (SBI).
Timepoint [3] 334944 0
Baseline, 12 days, 28 days (primary timepoint), and 42 days after intervention commencement.
Secondary outcome [1] 422342 0
Participants' self-defeating beliefs, social indifference beliefs, and expectancies of low pleasure: Demotivating Beliefs Inventory (DBI)
Timepoint [1] 422342 0
Baseline, 12 days, 28 days, and 42 days after intervention commencement.
Secondary outcome [2] 422499 0
Current affect: Positive and Negative Affect Schedule (PANAS)
Timepoint [2] 422499 0
Baseline, 12 days, 28 days, and 42 days after intervention commencement.
Secondary outcome [3] 422500 0
Future Orientation: Future Orientation Scale (FOS)
Timepoint [3] 422500 0
Baseline, 12 days, 28 days, and 42 days after intervention commencement.

Eligibility
Key inclusion criteria
Participants will be undergraduate psychology students from the University of Otago. They will be asked to take part in this study if they had previously indicated experiencing suicidal ideation in the past month.
Minimum age
18 Years
Maximum age
45 Years
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
None

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 is not concealed
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation feature in Qualtrics
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
Assuming a medium effect size of 0.5 and alpha level of 0.05, a power analysis suggests that a sample size of 31 participants would be required to achieve 90% power to detect a significant difference between pre-, mid-, post-, and follow-up intervention scores on the primary outcome measure (suicidal ideation) using a repeated-measures ANOVA. To accommodate a control group in the sample size, a total sample size of 62 participants would be needed to achieve 90% power to detect a significant difference between the intervention and control groups using a mixed-design ANOVA.

It is possible that some participants may drop out or fail to complete all the assessments. Assuming a 30% dropout rate, it is reasonable to aim for a sample size of at least 80 participants to ensure adequate statistical power and account for potential attrition.

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
1/08/2023
Actual
7/09/2023
Date of last participant enrolment
Anticipated
1/08/2024
Actual
20/06/2024
Date of last data collection
Anticipated
15/09/2024
Actual
2/08/2024
Sample size
Target
100
Accrual to date
Final
127
Recruitment outside Australia
Country [1] 25557 0
New Zealand
State/province [1] 25557 0
Otago

Funding & Sponsors
Funding source category [1] 313933 0
University
Name [1] 313933 0
University of Otago
Country [1] 313933 0
New Zealand
Primary sponsor type
University
Name
University of Otago
Address
275 Leith Walk
Dunedin North
Dunedin 9016
Country
New Zealand
Secondary sponsor category [1] 315800 0
None
Name [1] 315800 0
Address [1] 315800 0
Country [1] 315800 0
Other collaborator category [1] 282688 0
Individual
Name [1] 282688 0
A/Professor Richard Linscott
Address [1] 282688 0
Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016
Country [1] 282688 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 313078 0
Health and Disability Ethics Committees
Ethics committee address [1] 313078 0
Ethics committee country [1] 313078 0
New Zealand
Date submitted for ethics approval [1] 313078 0
26/07/2023
Approval date [1] 313078 0
06/09/2023
Ethics approval number [1] 313078 0

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

Contacts
Principal investigator
Name 126918 0
Miss Rebecca Salzano
Address 126918 0
Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016
Country 126918 0
New Zealand
Phone 126918 0
+64 22 403 2583
Fax 126918 0
Email 126918 0
[email protected]
Contact person for public queries
Name 126919 0
Rebecca Salzano
Address 126919 0
Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016
Country 126919 0
New Zealand
Phone 126919 0
+64 22 403 2583
Fax 126919 0
Email 126919 0
[email protected]
Contact person for scientific queries
Name 126920 0
Rebecca Salzano
Address 126920 0
Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016
Country 126920 0
New Zealand
Phone 126920 0
+64 22 403 2583
Fax 126920 0
Email 126920 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
In describing confidentiality to participants, we propose to undertake not disclosing to others any information they provide in the course of the research. It is crucial to maintain participants' privacy and autonomy, and sharing their information without their explicit consent could breach their confidentiality and compromise their trust in the study.


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
19258Study protocol    385965-(Uploaded-25-05-2023-14-02-34)-Study-related document.docx
19259Informed consent form    385965-(Uploaded-25-05-2023-13-40-12)-Study-related document.docx



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.