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Trial registered on ANZCTR


Registration number
ACTRN12621001510831p
Ethics application status
Submitted, not yet approved
Date submitted
23/09/2021
Date registered
4/11/2021
Date last updated
8/02/2022
Date data sharing statement initially provided
4/11/2021
Type of registration
Prospectively registered

Titles & IDs
Public title
Feasibility randomised pilot trial of Havening by zoom
Scientific title
A feasibility and acceptability randomised pilot trial of an innovative therapeutic strategy for increasing the well-being of staff by decreasing the impact of troubling memory and associated emotions when delivered via zoom.
Secondary ID [1] 304850 0
None
Universal Trial Number (UTN)
Trial acronym
HRCT
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Post Traumatic Stress Disorder 322940 0
Depression 322941 0
Anxiety 322942 0
Condition category
Condition code
Mental Health 320512 320512 0 0
Anxiety
Mental Health 320513 320513 0 0
Depression

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Intervention G
Materials: Computer with Zoom software, private room, chairs suitable for Havening,
Cushion and tissues

All practitioners will be female certified Havening practitioners.
One session of 30 – 90 min will be delivered via zoom. Time of session will vary depending on the participants response to the intervention.

Intervention.
The essential element of Intervention G is self-application of Havening Touch which comprises light stroking touch on the face, around the hair line down towards the chin and across the cheeks toward the ears, down the upper arms from the shoulder to the elbow and the palms of the hands. This touch will be applied through much of the session accompanying a range of verbal prompts and conversation. The structures for the verbal prompts and conversation are described below. All sessions will involve Event Havening, but the other structures will be used flexibly.


Event Havening
1. Check that the participant has a clear memory of an event which they would like to work on, they can speak about the event or not as they choose, but it will be necessary for them to bring the event into their mind for brief periods to rate the associated level of distress. The practitioner will invite the participant to describe the meaning of the event, how it has affected their lives and what change they would like to see.

2. The practitioner will explain the procedure of bringing the memory briefly into their consciousness, activating it, and identifying the SUDS associated with the memory. Then the practitioner will engage the participant in distraction techniques for 5-7 minutes during which time the touch will be applied. Performance in cognitive tasks is neither important nor recorded. The function is to distract the participant from the experience of the memory.


3. Ask the participant to activate the distressing memory by bringing it to mind. Allow a few seconds (up to 10) for recall. The practitioner will ask the participant to estimate Subjective Units of Distress (SUDS) associated with the recall of the event on a scale from 0 to 10.

4. Repeat steps 2, 3 until the SUDS score is 0, 1 or 2 and the participant’s emotional response associated with the event has changed considerably or disappeared.

5. If the SUDS do not reduce, the practitioner would review the memory to check on the specificity of the focus in the memory. It may be that there is an earlier, related memory which would be more useful to focus on.


NB: Cognitive tasks can be any activity which is not emotionally triggering and enables the participant to keep their attention away from the troubling memory. Commonly used examples include:
· Counting backwards in groups of 3 or 7
· Naming towns in NZ
· Explaining how to cook their favourite meal
· Explaining their dream holiday
· Humming a song

‘Transpirational’ Havening
This involves the participant verbally recalling a specific emotion or thought associated with the memory i.e. shame, guilty, worthless. The practitioner will prompt the participant to repeat the named feeling or thought they are experiencing while Havening touch is applied by themselves or the practitioner. The naming of these emotions gives the participant an opportunity to subjectively process them safely. This can be repeated for other emotions or thoughts which arise.
Hopeful Havening
Here, the client imagines looking to the future of good things to come. The feeling of hope should be experienced. The participant comes up with what they are hopeful for, or the practitioner may make suggestions based on what came up in the session. The participant then repeats what they are hopeful for while they or the practitioner apply the Havening touch.

‘Iffirmational’ Havening
This involves the practitioner repeating a statement of the form, “What IF …?” where the … represents a small but significant positive change which the participant can almost believe in. Iffirmational approach is adotped when an affirmation feels unbelievable E.g., ‘What if I forgive myself and others?’ If the participant feels resistance the iffirmation can be adapted to suit the participant; ‘What if a small part of me is willing to believe I could forgive myself and others one day?’
I
Procedure for Intervention G
The practitioner will greet, welcome the participant, take their blood pressure and pulse, attend to their comfort and ensure they are ready to begin.
For ten percent of the sessions the practitioner will confirm consent for the session to be video recorded for fidelity checking. The practitioner will inform the participant they can decline and can ask for the camera to be turned off at any time and for the recording immediately deleted.

The practitioner will introduce and teach the Havening touch and establish if the participant prefers to apply the touch themselves or have the practitioner do it.

The practitioner will guide an orienting conversation, checking the participant’s current level of stress and supporting them to use Havening touch combined with slow breathing to calm and be present.
The default procedure is to begin with Event Havening and follow this with Transpirational or Iffirmational Havening as appropriate. But variation in this order and emphasis is important as each session needs to be tailored to the individual person. For example, if the participant arrives with experience of some distress associated with some recent happening or has difficulty focusing on the memory Havening touch can be used to address these. This might include Transpirational Havening or simply encouraging the person to speak about their concern along with the application of Havening Touch.

At times in the session, eg after Event Havening, the practitioner will check in with the participant as to whether they have emotions or thoughts which still cause concern, or if there are other aspects of the memory they would like to process.
Before ending the session, the practitioner would invite the participant to do a final internal check in on their memory of the event, including scanning their emotions, body sensations and thoughts. At the conclusion of the session, the practitioner will offer the participant coaching in self Havening to address these at home.

Closing the session
If the distress is not able to be reduced to a point where the participant is able to engage in positive movement within an hour the session needs to be closed with incomplete resolution of feelings, thoughts and experiences. This needs to be clearly stated to the participant. If this is the case, the practitioner (while Havening Touch is continuing) will invite the participant to visualise a locked box in which to put the unresolved feelings, thoughts and experiences until appropriate support is available to process them further.

The practitioner will check with the participant about their safety and ability to return to their work and life. They will discuss what further support is appropriate and ensure this is available. This may involve contacting their identified support person and GP, a psychiatrist identified to support the study or the crisis team if indicated. They will check in with them in the next few hours and hand over to the research assistant the need for further checking in to ensure adequate support has been accessed.
Intervention code [1] 321232 0
Treatment: Other
Comparator / control treatment
Materials:
Computer with zoom software, private room, chairs suitable for Havening, cushion, tissues.

All practitioners will be female certified Havening practitioners.
One session of 30 – 90 min will be delivered via zoom. The time of session will vary depending on the participants' response to control treatment.



Intervention E (Control)
No touch will be used.
Safe place strategy.
The practitioner will invite the participant to identify a real or imaginary place where they feel peaceful and calm. The practitioner will coach them to imagine they are in this place and describe what they see, hear, feel when in that place.
The practitioner asks them to reflect on the experience and then to go back into the sanctuary in their imagination 2-3 times. The practitioner recommends the participant use this strategy when they feel distressed.
Exposure to the event.
This involves remembering the event and estimating the subjective units of distress (SUDS) between 0 and 10 they experience when remembering the event.
Empathic conversation.
This will involve minimally structured conversation, inviting the participant to talk about the event as much or as little as they choose. The practitioner will engage in active listening involving supportive attention, summarising and empathising with feelings expressed.
Distraction techniques
These are cognitive tasks which can be any activity which is not emotionally triggering and enables the participant to keep their attention away from the troubling memory. Commonly used examples include:
· Counting backwards in groups of 3 or 7
· Naming towns in NZ
· Explaining how to cook their favourite meal
· Explaining their dream holiday
· Humming a song

Procedure
The practitioner will greet, welcome the participant, take their blood pressure and pulse, attend to their comfort and ensure they are ready to begin.
For ten percent of the sessions the practitioner will confirm consent for the session to be video recorded for fidelity checking. The practitioner will inform the participant they can decline and can ask for the camera to be turned off at any time and for the recording immediately deleted.
The practitioner will teach the Safe Place Strategy.
The practitioner will invite the participant to focus on the memory and rate the SUDS and engage in empathic listening.
The practitioner will describe distraction and invite the participant to engage in cognitive distraction tasks.

The practitioner will again encourage the participant to practise use of the Safe Place technique and advocate use of this and distractions at times participant is finding emotions, thoughts, or memories challenging.
The practitioner will check on the participant’s wellbeing. If appropriate they will seek further support as described for Intervention G.
Control group
Active

Outcomes
Primary outcome [1] 328343 0
Between group comparison of IES scores at two-weeks and six-weeks post-intervention
Timepoint [1] 328343 0
IES will be measured at initial consent and screening and two and six weeks after the intervention.
Primary outcome [2] 328344 0
Between group comparison of proportion of participants with a IES score lesser than or equal to 34 at two-weeks and six-weeks post-intervention
Timepoint [2] 328344 0
These scales will be measured at the time of recruitment and two and six weeks after the intervention
Primary outcome [3] 330382 0
Qualitative information about the acceptability and feasibility of Havening via zoom. Likert scales collected at 1 and 6 week post-intervention, and two semi-structured qualitative interviews. First conducted within the first week post- intervention, and the second interview conducted at week 6.
Timepoint [3] 330382 0
Week 1, and week 6 post intervention
Secondary outcome [1] 398668 0
Between group comparison of WEMWBS scores at two-weeks and six-weeks post-intervention
Timepoint [1] 398668 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [2] 398669 0
Between group comparison of proportion of participants with a WEMWBS score greater than or equal to 41 at two-weeks and six-weeks post-intervention
Timepoint [2] 398669 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [3] 401889 0
Between group comparison of GAD7 scores at two-weeks and six-weeks post-
Timepoint [3] 401889 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [4] 402559 0
Between group comparison of proportion of participants with a GAD7 score lesser than or equal to five at two-weeks and six-weeks post-intervention
Timepoint [4] 402559 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [5] 402665 0
Between group comparison of PHQ9 scores at two-weeks and six-weeks post-intervention
Timepoint [5] 402665 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [6] 402666 0
Between group comparison of proportion of participants with a PHQ9 score lesser than or equal to six at two-weeks and six-weeks post-intervention
Timepoint [6] 402666 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [7] 402667 0
Between group comparison of Emoqol scores at two-weeks and six-weeks post-intervention
Timepoint [7] 402667 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [8] 402668 0
Between group comparison of proportion of participants with a Emoqol score greater than or equal to 70 at two-weeks and six-weeks post-intervention
Timepoint [8] 402668 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [9] 402669 0
Between group comparison of blood pressure and pulse at five-minutes post-intervention
Timepoint [9] 402669 0
Scales will be measured at the time of recruitment and two and six weeks after the intervention
Secondary outcome [10] 406041 0
Qualitative information as to how acceptable participants found Havening and the control condition. Likert scales collected at 1 and 6 week post-intervention, and two semi-structured qualitative interviews. First conducted within the first week post- intervention, and the second interview conducted at week 6.
Timepoint [10] 406041 0
Week 1 and week 6 post intervention
Secondary outcome [11] 406042 0
Qualitative information as to adverse effects of Havening and the control intervention. Likert scales collected at 1 and 6 week post-intervention, and two semi-structured qualitative interviews. First conducted within the first week post- intervention, and the second interview conducted at week 6.
Timepoint [11] 406042 0
Week 1 and week 6 post intervention
Secondary outcome [12] 406043 0
Data about the feasibility of the measures used, challenges involved in collecting data. Likert scales collected at 1 and 6 week post-intervention, and two semi-structured qualitative interviews. First conducted within the first week post- intervention, and the second interview conducted at week 6.
Timepoint [12] 406043 0
Week 1 and Week 6 poster intervention
Secondary outcome [13] 406044 0
Data about recruitment response to advertisements for people with a troubling memory and description of the population recruited. we will gather data and observe the recruitment statistics over time(Rate, demographic, follow-up, how they heard about it (in the semi structured interview).
Timepoint [13] 406044 0
Screening and recruitment throughout the study period

Eligibility
Key inclusion criteria
Pre recruitment adaption:
1. Aged 18 years - 75 years.
2. Having a well recalled memory of a previous event which causes them distress or symptoms.
Minimum age
18 Years
Maximum age
75 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
1. People with scores above 20 on the PHQ or suicidal with plans.
2. People who are not agreeing to identify a support person and GP and give consent for them to be contacted in the context of concern about their wellbeing being identified in the course of the study.
3. People who are unable to comprehend the information sheet and the consent form.
4. People who are not fluent in English

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)
Randomisation is done centrally by computer.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Participants are recruited and randomly assigned to either the intervention or the control group using automated randomization systems (e.g. computer generated).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s

The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Intention-to-treat analysis will be applied. The interventions to be compared with controls.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/03/2022
Actual
Date of last participant enrolment
Anticipated
31/08/2022
Actual
Date of last data collection
Anticipated
14/09/2022
Actual
Sample size
Target
80
Accrual to date
Final
Recruitment outside Australia
Country [1] 24000 0
New Zealand
State/province [1] 24000 0
Auckland

Funding & Sponsors
Funding source category [1] 309223 0
Hospital
Name [1] 309223 0
Starship Children's Hospital
Country [1] 309223 0
New Zealand
Primary sponsor type
Individual
Name
Josephine Stanton
Address
Child and Family Unit
Level 1 Starship
Starship Children's Hospital
2 Park Rd
Grafton
Auckland, 1023
Country
New Zealand
Secondary sponsor category [1] 310186 0
Individual
Name [1] 310186 0
Briar Greedus
Address [1] 310186 0
ADHB
Grafton Site
2 Park Road,
Grafton,
Auckland 1023
Country [1] 310186 0
New Zealand
Secondary sponsor category [2] 310964 0
Individual
Name [2] 310964 0
Bruce Arroll
Address [2] 310964 0
Department of General Practice and Primary Health Care
Faculty of Medical and Health Sciences
The University of Auckland
Private Bag 92019
Auckland Mail Centre
Auckland 1142
New Zealand
Country [2] 310964 0
New Zealand
Secondary sponsor category [3] 310965 0
Individual
Name [3] 310965 0
Karen Lindsay
Address [3] 310965 0
Department of Clinical Immunology and Allergy
Auckland City Hospital
2 Park Rd
Grafton
Auckland 1023
Country [3] 310965 0
New Zealand
Secondary sponsor category [4] 310966 0
Individual
Name [4] 310966 0
Shamsul Shah
Address [4] 310966 0
Department of Palliative Care
Auckland City Hospital
2 Park Rd
Grafton
Auckland 1023
Country [4] 310966 0
New Zealand
Secondary sponsor category [5] 310967 0
Individual
Name [5] 310967 0
Kamaia Pere
Address [5] 310967 0
NDHB
Whangarei Hospital
Maunu Road,
Private Bag 9742,
Whangarei
0148
Country [5] 310967 0
New Zealand

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 309072 0
AHRECS
Ethics committee address [1] 309072 0
Ethics committee country [1] 309072 0
New Zealand
Date submitted for ethics approval [1] 309072 0
13/08/2021
Approval date [1] 309072 0
Ethics approval number [1] 309072 0

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

Contacts
Principal investigator
Name 112874 0
Dr Josephine Stanton
Address 112874 0
Child and Family Unit
Level 1 Starship
2 Park Rd
Grafton
Auckland 1023
Country 112874 0
New Zealand
Phone 112874 0
+64 21683962
Fax 112874 0
+6493078944
Email 112874 0
[email protected]
Contact person for public queries
Name 112875 0
Josephine Stanton
Address 112875 0
Child and Family Unit
Level 1 Starship
2 Park Rd
Grafton
Auckland 1023
Country 112875 0
New Zealand
Phone 112875 0
+64 21683962
Fax 112875 0
+6493078944
Email 112875 0
[email protected]
Contact person for scientific queries
Name 112876 0
Josephine Stanton
Address 112876 0
Child and Family Unit
Level 1 Starship
2 Park Rd
Grafton
Auckland 1023
Country 112876 0
New Zealand
Phone 112876 0
+64 21683962
Fax 112876 0
+6493078944
Email 112876 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
Yes
What data in particular will be shared?
All de-identified data can be shared
When will data be available (start and end dates)?
April 2022 to April 2023
Available to whom?
Bonafide researchers in the area
Available for what types of analyses?
Any
How or where can data be obtained?
Via principal investigator, Dr Josephine Stanton, [email protected] or [email protected]


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
12792Ethical approval  [email protected]
12793Informed consent form  [email protected]



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.