ANZCTR - Registration

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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]

None

Universal Trial Number (UTN)

Trial acronym

HRCT

Linked study record

Health condition

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

Post Traumatic Stress Disorder

Depression

Anxiety

Condition category

Condition code

Mental Health

Anxiety

Mental Health

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]

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]

Between group comparison of IES scores at two-weeks and six-weeks post-intervention

Timepoint [1]

IES will be measured at initial consent and screening and two and six weeks after the intervention.

Primary outcome [2]

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]

These scales will be measured at the time of recruitment and two and six weeks after the intervention

Primary outcome [3]

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]

Week 1, and week 6 post intervention

Secondary outcome [1]

Between group comparison of WEMWBS scores at two-weeks and six-weeks post-intervention

Timepoint [1]