Trial Review

The ANZCTR website will be unavailable from 1pm until 3pm (AEDT) on Wednesday the 30th of October for website maintenance. Please be sure to log out of the system in order to avoid any loss of data.

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
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
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] 297500 0
Nil
Universal Trial Number (UTN)
U1111-1221-0201
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Suicidality 311693 0
Condition category
Condition code
Mental Health 310318 310318 0 0
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] 313742 0
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] 319209 0
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] 319209 0
Baseline and 8-week follow-up
Secondary outcome [1] 367312 0
Changes in emotion regulation ability, measured by a standard questionnaire: The Difficulties in Emotion Regulation Scale.
Timepoint [1] 367312 0
Baseline and 8-week follow-up
Secondary outcome [2] 367598 0
Changes in emotion regulation ability, measured by a standard questionnaire: The Emotion Reactivity Scale.
Timepoint [2] 367598 0
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
75
Accrual to date
Final
65
Recruitment outside Australia
Country [1] 21305 0
New Zealand
State/province [1] 21305 0
Wellington

Funding & Sponsors
Funding source category [1] 302062 0
University
Name [1] 302062 0
University of Otago Wellington
Country [1] 302062 0
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] 301875 0
None
Name [1] 301875 0
Address [1] 301875 0
Country [1] 301875 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 302743 0
University of Otago Human Ethics Committee
Ethics committee address [1] 302743 0
Ethics committee country [1] 302743 0
New Zealand
Date submitted for ethics approval [1] 302743 0
08/10/2018
Approval date [1] 302743 0
24/10/2018
Ethics approval number [1] 302743 0
18/168

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

Contacts
Principal investigator
Name 91242 0
Mr Steven Davey
Address 91242 0
University of Otago Wellington,
23, Mein Street, Newtown, Wellington, 6242
Country 91242 0
New Zealand
Phone 91242 0
+64 273159291
Fax 91242 0
Email 91242 0
[email protected]
Contact person for public queries
Name 91243 0
Steven Davey
Address 91243 0
University of Otago Wellington,
23, Mein Street, Newtown, Wellington, 6242
Country 91243 0
New Zealand
Phone 91243 0
+64 273159291
Fax 91243 0
Email 91243 0
[email protected]
Contact person for scientific queries
Name 91244 0
Steven Davey
Address 91244 0
University of Otago Wellington,
23, Mein Street, Newtown, Wellington, 6242
Country 91244 0
New Zealand
Phone 91244 0
+64 273159291
Fax 91244 0
Email 91244 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
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.TypeCitationLinkEmailOther DetailsAttachment
1445Informed consent form    377046-(Uploaded-23-02-2019-12-37-50)-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
SourceTitleYear of PublicationDOI
EmbaseAdapting a two-stage water load test to measure gastric sensitivity over time.2022https://dx.doi.org/10.1016/j.physbeh.2022.113856
N.B. These documents automatically identified may not have been verified by the study sponsor.