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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]

None

Universal Trial Number (UTN)

U1111-1293-0495

Trial acronym

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Suicidal Ideation

Schizotypy

Condition category

Condition code

Mental Health

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]

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]

Severity of recent suicidal ideation: Suicidal Ideation Attributes Scale (SIDAS).

Timepoint [1]

Baseline, 12 days, 28 days (primary timepoint), and 42 days after intervention commencement.

Primary outcome [2]

Participants' beliefs related to their future experience of pleasureable events: Beliefs About Pleasure Scale (BAPS).

Timepoint [2]

Baseline, 12 days, 28 days (primary timepoint), and 42 days after intervention commencement.

Primary outcome [3]

Participants' beliefs related to their ability to enjoy future events: Savoring Beliefs Inventory (SBI).

Timepoint [3]

Baseline, 12 days, 28 days (primary timepoint), and 42 days after intervention commencement.

Secondary outcome [1]

Participants' self-defeating beliefs, social indifference beliefs, and expectancies of low pleasure: Demotivating Beliefs Inventory (DBI)

Timepoint [1]

Baseline, 12 days, 28 days, and 42 days after intervention commencement.

Secondary outcome [2]

Current affect: Positive and Negative Affect Schedule (PANAS)

Timepoint [2]

Baseline, 12 days, 28 days, and 42 days after intervention commencement.

Secondary outcome [3]

Future Orientation: Future Orientation Scale (FOS)

Timepoint [3]

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?

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]

New Zealand

State/province [1]

Otago

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago

Address [1]

275 Leith Walk
Dunedin North
Dunedin 9016

Country [1]

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]

None

Name [1]

Address [1]

Country [1]

Other collaborator category [1]

Individual

Name [1]

A/Professor Richard Linscott

Address [1]

Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016

Country [1]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
PO Box 5013
Wellington 6140

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

26/07/2023

Approval date [1]

06/09/2023

Ethics approval number [1]

Summary

Brief summary

We seek to determine whether an online psychological intervention (positive episodic future thinking, EFT-P) effectively increases positive beliefs about the future and decreases suicidal ideation. Through this, we seek to understand how personality influences the beliefs that one holds and one’s responsiveness to future reward and pleasure over time, and whether these influence one’s propensity to think about suicide.

Our first aim is to investigate whether one’s beliefs about the future can be altered by improving one’s ability to mentally simulate positive events in one’s personal future, and whether these increased positive beliefs lead to a reduction in suicidal thinking.

A secondary aim was to examine who may benefit most from EFT-P. Specifically, we propose to examine whether EFT-P is more effective for people with schizotypy, a subclinical manifestation of schizophrenia. In addition, we examine whether the EFT-P’s effectiveness is associated with factors such as the individual’s mood, their existing tendency to use mental imagery in everyday scenarios, and their general optimism towards the future.

Trial website

Trial related presentations / publications

Public notes

Understanding how specific personality traits contribute to the development of suicidality is important to decreasing the rates of suicide in the wider population. Schizotypy, the subclinical expression of schizophrenia, has been identified as an important predictor of suicidal thinking. As with schizophrenia, schizotypy has positive (e.g., hallucinations; delusions) and negative (e.g., decrease in emotional expression, motivation, and speech) components. Previous research has found that negative schizotypy predicts STB without any specific confounding factors (O’Hare et al., 2020). That is, evidence suggests that negative schizotypy may cause STB.

In research we have conducted previously (University of Otago Human Ethics Committee (Health); H21/081, H22/095), we have found that this relationship is heavily influenced by anticipation of future pleasure and core beliefs relating to one’s personal future. These beliefs about the future could be modifiable, and increasing one’s positive beliefs about their future experience of pleasurable experiences could lead to a reduction in suicidal thinking.

One approach that shows promise in improving people’s anticipation and beliefs are interventions aimed at improving one’s ability to mentally visualise positive future experiences (episodic future thinking, EFT; Hallford et al., 2020; Renner et al., 2019, 2021). In the proposed research, we investigate whether episodic future thinking of positive events (EFT-P) will be successful in reducing negative beliefs about the future and reducing suicidal thinking. In addition, we hope to determine whether EFT-P is more effective for individuals with high levels of negative schizotypy.

Contacts

Principal investigator

Name

Miss Rebecca Salzano

Address

Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016

Country

New Zealand

Phone

+64 22 403 2583

Fax

salre948@student.otago.ac.nz

Contact person for public queries

Name

Rebecca Salzano

Address

Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016

Country

New Zealand

Phone

+64 22 403 2583

Fax

salre948@student.otago.ac.nz

Contact person for scientific queries

Name

Rebecca Salzano

Address

Department of Psychology
University of Otago
275 Leith Walk
Dunedin North
Dunedin 9016

Country

New Zealand

Phone

+64 22 403 2583

Fax

salre948@student.otago.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

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.	Type	Citation	Link	Email	Other Details	Attachment
19258	Study protocol					385965-(Uploaded-25-05-2023-14-02-34)-Study-related document.docx
19259	Informed 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.

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No additional documents have been identified.

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