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Trial registered on ANZCTR

Registration number

ACTRN12619000324112

Ethics application status

Approved

Date submitted

23/02/2019

Date registered

4/03/2019

Date last updated

21/10/2019

Date data sharing statement initially provided

4/03/2019

Date results information initially provided

21/10/2019

Type of registration

Prospectively registered

Titles & IDs

Public title

Where is an emotion? Using body focus as a method of improving emotion regulation to inform suicide prevention initiatives

Scientific title

Where is an emotion? Using targeted visceroception as a method of improving emotion regulation in healthy participants to inform suicide prevention initiatives

Secondary ID [1]

Nil

Universal Trial Number (UTN)

U1111-1221-0201

Trial acronym

Linked study record

Health condition

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

Suicidality

Condition category

Condition code

Mental Health

Suicide

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

Visceroceptive awareness intervention. This involves directing attention to the physiological activity of a part of the body, where these parts differ across experimental groups. One group will focus attention on cardiac activity with another group focussing on gut activity in the lower abdomen.

These groups undertake the intervention over an extended period of 8 weeks, 6 days per week, 20 minutes per day. Participants will be provided with written instructions online (developed by the Principal Investigator) for how to approach this daily task. These instructions will include the body posture to adopt during each session, the focal point for the task (being either cardiac or gastrointestinal, not skeletal), ensuring the set up in the room is comfortable (e.g. comfortable temperature, comfortable and stable chair), and common pitfalls when undertaking meditation (e.g. mind wandering). When beginning the task, participants in the cardiac focus group will be cued with an image highlighting the chest area, with those in the gut focus group being cued by an image highlighting the lower abdomen. They will be instructed to focus within the body at these locations. Further, there will be opportunities for participants to ask questions face to face and/or over email. The intervention (and knowledge of group allocation) will be introduced during an initial laboratory visit, which will be reinforced by the online materials. The first meditation session takes place after the initial laboratory visit.

The Principal Investigator (PI) has based the intervention on instructions provided in journal articles using visceroception, in combination with a meditation framework taken from a traditional Zen Buddhist practice (the PI has 20 years' experience of this framework with the Zen Centre, London). This framework will be used to fix the bodily posture (upright position, curved lower back, chest out, ears in line with the shoulders, eyes lowered, one hand gripping the other in the lap) and set the environmental conditions for each daily session (room temperature, medium level lighting, no noise or other distractions such as food, and ensuring a comfortable room temperature) as well as some guidance on what is meant by focussing attention on physiological activity (i.e. emphasising the difference between attending to bodily locations and thinking about those locations).

The intervention will take place in the participants' own home, using their own computer to access an online guided task. The task includes responding to several questions about any changes in emotional experience throughout the study period.

In terms of adherence, all participants will be logging in to a website to complete the daily task. Each log in is automatically recorded, including time spent and all activities within the session. This includes the responses to the questions indicated previously. In the event that participants do not log in for more than 2 consecutive days, they will be contacted by the researcher. Further, at the 4-week midpoint, the researcher will contact each participant to check for any issues or difficulties they may be experiencing. This will be a brief Skype conversation or, otherwise, an email exchange.

Intervention code [1]

Prevention

Comparator / control treatment

The control group will access the online questions asking about emotional experiences, but will not undertake the visceroception task. Members of the control group will be offered access to the intervention. However, it is envisaged that simply reflecting on emotional experiences in a daily diary may also be of benefit.

The control group will answer this questions the same number of times as the experimental groups (6 days per week for 8 weeks).

In terms of time requirements, the online questions may attract brief or longer responses, depending on any emotionally relevant events occurring in the preceding 24 hours. A respondent may simply indicate nothing to report, or may take substantially longer depending on the number of events experienced and the level of detail they wish to provide. No upper limit will be imposed here. All such data will be qualitative.

Control group

Active

Outcomes

Primary outcome [1]

Change in mean reaction time to the detection of a bodily change in response to emotional stimuli. This is a composite primary outcome.

This will be assessed using emotional images from the International Affective Picture System (IAPS). Negative and neutral images will be presented on a computer screen using the presentation software package "Superlab'. Participants will have their ability to visually orient restricted by the use of a chin rest and a fixation cross onscreen. After each stimulus, reaction time for bodily reactions will be recorded using a mouse button, again recorded on 'Superlab". Heart rate will be recorded using ECG throughout to test for increased heart rate deceleration following negative stimuli (an established physiological reaction) and to control for known differences in cardiac response when an emotional stimulus is presented at systole compared with diastole.

Timepoint [1]

Baseline and 8-week follow-up

Secondary outcome [1]

Changes in emotion regulation ability, measured by a standard questionnaire: The Difficulties in Emotion Regulation Scale.

Timepoint [1]

Baseline and 8-week follow-up

Secondary outcome [2]

Changes in emotion regulation ability, measured by a standard questionnaire: The Emotion Reactivity Scale.

Timepoint [2]

Baseline and 8-week follow up

Eligibility

Key inclusion criteria

(a) BMI equal to or lower than 30; 32 for Maori/PI;
(b) Currently enrolled on a full time medical or nursing degree/diploma or allied health degree/diploma OR already qualified and working as a doctor/nurse/allied health professional;
(c) Regular levels of physical activity: at least 150 minutes of moderate-intensity aerobic physical activity throughout the week or least 75 minutes of vigorous-intensity aerobic physical activity or an equivalent combination of moderate- and vigorous-intensity activity (based on World Health Organisation guidelines);
(d) Normal or corrected vision;
(e) Normal or corrected hearing;
(f) Right-handed;
(g) Aged 18-35 years;
(h) Availability for the entire study period.

Minimum age

18 Years

Maximum age

35 Years

Sex

Both males and females

Can healthy volunteers participate?

Yes

Key exclusion criteria

(a) Poor physical health (including gastrointestinal disorders, heart disease, kidney disease, respiratory disease, plus medication use that may influence awareness or creation of bodily sensations);
(b) Poor psychological, psychiatric or neurological health (e.g. alexithymia, schizophrenia, depression, anxiety, brain injury);
(c) Somatosensory amplification;
(d) If female: in pregnancy;
(e) Formal dance or drama training;
(f) Formal musical training;
(g) Formal meditation or mindfulness training.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

This will be achieved using sealed notes provided to participants during their initial laboratory visit.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

This will be achieved using permuted block randomisation.

Masking / blinding

Blinded (masking used)

Who is / are masked / blinded?

The people administering the treatment/s
The people assessing the outcomes

Intervention assignment

Parallel

Other design features

Phase

Not Applicable

Type of endpoint/s

Efficacy

Statistical methods / analysis

A biostatistician was consulted for the power analysis calculation. This was based on the reaction time (RT) measures in the most closely related published research paper, which show a mean RT of 2134.1ms (SD = 856.6ms) pre-treatment and 1403.6ms (SD = 462.3ms) post-treatment for meditators, and 1865.1ms (SD = 800.4ms) pre-treatment and 1893ms (SD = 780.6ms) post-treatment for controls. This gave a treatment-by-time partial eta-squared of 0.15, with a p-value of 0.03. Using the same partial eta-squared for the three group, three time point studies, with alpha = 0.05 and 80% power, a minimum of 54 participants would be required in total (across all group conditions). We will aim for 25 participants per group, assuming a dropout rate of at least 20%.

Generalised Estimating Equations (GEE) will be used to analyse the 2 data points, including variable interactions. GEE can account for repeated measures as well as the potential problem that the outcome variable (RT) may not be normally distributed (although it will be continuous). Using GEE, the effects of the predictors on RT can be modelled under different circumstances, and the interrelationships between predictors can also be investigated.

Recruitment

Recruitment status

Completed

Date of first participant enrolment

Anticipated

1/04/2019

Actual

13/05/2019

Date of last participant enrolment

Anticipated

1/05/2019

Actual

13/05/2019

Date of last data collection

Anticipated

Actual

2/10/2019

Sample size

Target

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Wellington

Funding & Sponsors

Funding source category [1]

University

Name [1]

University of Otago Wellington

Address [1]

23, Mein Street, Newtown, Wellington. 6242

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Otago Wellington

Address

23, Mein Street, Newtown, Wellington. 6242

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

Address [1]

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

University of Otago Human Ethics Committee

Ethics committee address [1]

1st Floor, Scott/Shand House, 90 St David's Street, Dunedin, 9016

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

08/10/2018

Approval date [1]

24/10/2018

Ethics approval number [1]

18/168

Summary

Brief summary

The project will investigate whether the awareness of emotion (by a process of "visceroception" - sensing the viscera) as it manifests in the body is connected with the ability to manage it effectively (i.e. “emotion regulation”). The central focus of the project is a particular aspect of this manifestation: whether emotional feeling is physically localised. Further, it investigates whether an inhibitory process impedes awareness of localisation and whether it is possible to train people to identify it. The ultimate aim of the project is to assess whether there are grounds for thinking this training could be used in suicide prevention efforts.

The primary hypothesis is: one of the visceroception groups will show significantly faster reaction times (RTs) to emotional stimuli compared with both of the other groups after baseline and there will be a greater change between baseline and follow-up. Each of the visceroception groups separately and combined will show significantly faster RTs than the control group.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Mr Steven Davey

Address

University of Otago Wellington,
23, Mein Street, Newtown, Wellington, 6242

Country

New Zealand

Phone

+64 273159291

Fax

[email protected]

Contact person for public queries

Name

Mr Steven Davey

Address

University of Otago Wellington,
23, Mein Street, Newtown, Wellington, 6242

Country

New Zealand

Phone

+64 273159291

Fax

[email protected]

Contact person for scientific queries

Name

Mr Steven Davey

Address

University of Otago Wellington,
23, Mein Street, Newtown, Wellington, 6242

Country

New Zealand

Phone

+64 273159291

Fax

[email protected]

Data sharing statement

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

No/undecided IPD sharing reason/comment

The ethical approval for the study was provided on the basis that the data would be stored securely in the University for a period of 5 years before being securely disposed of, without mention of sharing publicly.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
1445	Informed consent form					377046-(Uploaded-23-02-2019-12-37-50)-Study-related document.pdf

Results publications and other study-related documents

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No documents have been uploaded by study researchers.

Documents added automatically

Source	Title	Year of Publication	DOI
Embase	Adapting a two-stage water load test to measure gastric sensitivity over time.	2022	https://dx.doi.org/10.1016/j.physbeh.2022.113856

N.B. These documents automatically identified may not have been verified by the study sponsor.

Trial Review

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